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2020 Predictions in Real-World Evidence, The Renewed Importance of Documentation
The Renewed Importance of Documentation
Inadequate/inaccurate case histories form the second most commonly cited deficiency in US-FDA inspections of clinical investigator sites.
Similarly, source documentation issues ranked 5th among the top 10 findings from European Medicines Agency (EMA) inspections of investigator sites in 2009 and in some instances the findings were classified ‘critical’. Not surprisingly, clinical trial monitors and auditors also report documentation issues as a frequent area of GCP concern.
In what’s being called the “post-truth” era, we need more steak and less sizzle. Healthcare is too important to be cavalier in patient treatment or in the drug and device development space. In both our methods and our discourse, it is incumbent upon us to give documented evidence and eliminate any cause for doubt in our claims. If we truly want to establish the value of drugs and devices—and put appropriate concerns over inappropriate pricing in perspective—we need to reaffirm the importance of using appropriate scientific methods to generate useful, persuasive, impactful data.
Regulatory and quasi-governmental agencies are articulating more defined expectations over real-world data as the basis for assertions of real-world value. In light of these conditions, life sciences companies are affording greater autonomy and authority to internal teams in 2020, to the extent that even the most seemingly benign story may not go unsubstantiated.
We will get to see greater emphasis on clarity in communications so that transparency and candor—particularly regarding the analytical limitations of real-world evidence—become hallmarks of integrity and responsible citizenship within the healthcare community.
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Scientists To Study Typhoid Infection Via Controlled Human Infection Models
India has a significant burden of typhoid, especially in young children. And, this disease is becoming more and more widespread along the length and breadth of the country. To help the entire country stay prevented against this disease, and effectively treat those that are already infected with it, it is essential that we first understand how the pathogen transmits the disease, how the disease progresses, how an individual responds to it, and how an effective treatment can be formulated to encounter the disease. In order to understand all of this, researchers have proposed Clinical Human Infection Model (CHIM) studies, in which healthy participants will be infected with a weakened strain of the pathogen in a controlled setting so that every detail about the disease can be learnt, in order to be able to develop appropriate vaccines.
Why CHIM?
There is already a rotavirus vaccine that has been tested in other countries, and shows 90% efficacy. Now you may ask why we simply cannot use this vaccine, instead of putting our fellow citizens at risk. The reason here is that while the vaccine shows 90% efficacy in other countries, it shows only 50% results in India. Similarly, oral vaccinations for other diseases like cholera and polio have shown good results in other countries, but low efficacy in India. This is why we cannot depend on other populations for testing and vaccines, when we clearly know that Indians have a different genetic makeup, socio-economic backgrounds, and nutritional demands. This is why researchers have come up with the CHIM proposal, which can prove to be a faster way to develop vaccines after studying about the disease in human models. And, this can prove to be the best solution for typhoid, as typhoid strains can only be present in humans, and cannot be artificially developed or cultured in labs.
How can CHIM be conducted?
Now one problem here is that India has an ethical obligation where clinical trials cannot be conducted on humans. This is why typhoid strains that were developed in India, were tested in the Oxford University in UK. Why it is important to conduct the same on humans is firstly because typhoid affects only humans, and secondly because animals and humans have different physiologies. Thus, it has been decided to test typhoid pathogens on humans, starting with only a few people, say five, which can then be conducted on a larger number of people if the studies go well. However, even though only five people are selected, it is important to have the volunteers and their family members informed thoroughly about the disease and any kinds of risks involved. Although the entire study will be done in a controlled setting under the supervision of experts, after which the volunteers will be examined for an entire year, there could be rare chances of side effects like mild fever or nausea. Also, volunteers will be isolated from the community for a defined period of infectivity of the pathogen, in order to avoid transmission of the disease to the community.
To help your countrymates with many such progresses and advancements, you can join the league of researchers trying to do their job perfectly. And for this, you will need the best clinical research training in Bangalore from a reputed institute like Avigna Clinical Research Institute.
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India Joins Global Antimicrobial Resistance Research And Development Hub
India is among the countries with the highest amount of bacterial diseases in the world, and is also the largest consumer of antibiotics in the world, wherein the consumption has increased by 103% from 2000 to 2015! This is the highest increase in low and middle income countries. As per the reports of the World Health Organization, more than 7,00,000 people die from microbial infections every year! And, this number is only set to rise above the mark of 10 million deaths per year in the coming years, if no proper action is taken. Microbial infection has thus become a cause of worry not only in India, but also many other developing nations where the burden of infectious disease is high, and the healthcare spending is low.
India Joins Global Antimicrobial Resistance Research And Development Hub
With such high number of bacterial disease patients, India gives a great platform for relevant researches. And, this is why the country has become a part of the Global Antimicrobial Resistance Research and Development Hub on 12 September 2019. This development hub was launched during the 71st session of the World Health Assembly in 2018, aiming to help countries decide the allocation of resources for research and development on antimicrobial resistance, by identifying gaps and overlaps. The hub will also promote coordination among governments in the fight against antimicrobial resistance.
What is the Hub?
This hub is headquartered in Germany, whose membership is open to countries and philanthropic foundations. This global partnership includes a total number of 16 countries, the European Commision, four international organizations, and two philantrophic foundations. And now, with India being a member, the hub now represents more than half the world’s population!
What is the role of this Hub?
The developmental hub has a provisional work plan from 2018 to 2021 to propose to develop a dynamic dashboard, establish operational activities and procedures, and engage experts in ad-hoc Expert Advisory Groups to understand the range of R&D incentives and gaps in the incentive toolbox. With this work plan, a global network of researchers ReAct, pointed out six issues in September 2018. They not only wanted to reduce the threat of antibiotics resistance, but also wanted more clarity in the hub’s role in taking action and influencing decision-making, needing to look beyond antibiotic R&D pipeline, and avoiding distorting the prioritization of investments.
What does Renu Swarup have to say?
Renu Swarup, secretary department of biotechnology, Union Ministry of Science & Technology, in a press release, said, “We all have a role to play to protect the efficacy of antimicrobial agents and to support the efforts of the different sectors at national, regional and global levels. Working together, we can address this threat and change the trajectory of health for humanity. By partnering, with the Global AMR R&D Hub, we look forward to working with all partners to leverage their existing capabilities, resources and collectively focus on new R&D intervention to address drug resistant infections.”
As India goes global, it brings more and more opportunities for researchers to get amazing job opportunities. But for this, one needs the best clinical research training in Bangalore from a reputed institute like Avigna Clinical Research Institute.
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No Clinical Trials In India Approved!
The blog title may scare you for once, wondering how you can take a medication without having it tested and approved. But hold on, there is more to what you have just read. You can trust the Indian government to not risk anyone’s life. So then, what it is about, you may wonder.
What is the no-approval decision for clinical trials?
The fact is that the Indian government has decided not to conduct clinical trials for new drugs that have been tested and approved for use in America, United Kingdom, Australia, and Japan. However, this approval will be permitted only if the global trials of such developed markets included Indian patients. A senior government official confirmed this by giving an example, saying that, “If a US based company conducted clinical trials that also included Indian patients and the drug is marketed in the US, there will be no need for conducting local clinical trials to prove its efficacy in India.”
What is the motive behind this move?
This move is expected to reduce the time taken by pharmaceutical firms to introduce drugs in India, while also preventing duplication of studies. In this way, drugs can be introduced in Indian markets sooner. This seems to be great for those patients who are suffering from serious illnesses and can’t seem to find a solution. Maybe a new treatment that has been developed and approved for Indians out of the country works for such patients.
What other changes have been made?
After the new Drugs and Clinical Trials Rules 2019, the requirement of local clinical trials has also been waived off for the drugs approved and marketed in the above mentioned countries. The data generated outside the country will be acceptable, provided that the data includes Indians too.
The government has also removed a clause in the clinical trials rules that commanded the sponsor to pay 60% of compensation upfront in case of death or permanent disability of a patient during a clinical trial. Once it is proven that the injury or death has occurred due to the clinical trial, only then will the company have to pay the total amount in compensation. Also, the government made it compulsory for firms to provide medical management as long as required, or till a time that it is established that the injury is not related to the clinical trial.
In case of application of conducting a clinical trial of a new drug as part of discovery, research, and manufacture in India, the application will be disposed off within a period of 30 days. And, in case of no communication from the Drug Controller General of India within this time period, the application will be considered approved.
With all these changes made, let us wait and look at how the clinical trials rules work for the country. To help, you can also take up clinical research as your career. And for this, you need the best clinical research training in Bangalore from a reputed institute like Avigna Clinical Research Institute.
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History Of Clinical Trials Rules
All of us who are concerned with or interested in the clinical research field of our country would be aware of the New Drugs and Clinical Trials Rules 2019 that have been in effect since 19 March 2019. But, the journey of clinical trials hasn’t been easy to reach the level where it stands today. There have been lots of ups and downs in the journey, ever since the rules that were set up in the year 1945. There were also lots of amendments made after which we see the current rules that are being abided by so carefully in India. Let us take a look at this difficult and challenging journey that our clinical trials have been through since.
1945 – The first rules for clinical research came up in 1945, where the trials were conducted in accordance with the requirements set out in Schedule Y of the Drugs and Cosmetics Rules 1945. But, there were concerns regarding patient safety and compensation provided to the patients in cases of adverse effects suffered during the participation in clinical trials.
2013 – A Public Interest Litigation (PIL) was filed in the year 2012 by a patient-centric NGO before the Supreme Court of India, claiming malpractices in the conduct of clinical trials by both governmental and non-governmental organizations. As a response to this PIL, certain amendments were made to the rules to regulate the clinical trials conducted in India, and confirm that the approvals were based on all relevant aspects of safety and efficacy. As per the modified rules, there was provision for compensation to an affected participant in case of death or injury during the trial. Also, the new rules included the requirement of obtaining approval by an Ethics Committee, registration of the trial with the Clinical Trials Registry of India, and submission of reports of serious adverse events.
2018 – Then, in 2018, the draft of the current rules was published. Drafted on 1st February, 45 days were given to the stakeholders to send comments on these rules. However, there was much delay in considering the rules and finalizing them; which finally were confirmed and notified on 19 March 2019.
The current clinical trials rules
Now, the latest rules, named as the new Drugs And Clinical Trials Rules 2019, aim to promote clinical research in India through transparent and faster approval processes. As per these rules,
Any drugs discovered in India will be deemed approved within 30 working days.
Any drugs developed and approved of outside India will be approved to be used in India within 90 working days.
Any drug that needs to be used for the first time on a patient will be provided free of cost by the sponsor.
Any drugs permitted to be imported in India for sale and distribution needn’t require a clinical trial to be executed in India again.
For application for conduct of clinical trials for orphan drugs, there will be no fee charged.
In case of any injury caused to the participant because of the clinical trial, medical management will be provided as long as required.
In case of death or permanent disability of the participant because of the clinical trial, compensation to the participant will be decided upon by the Drug Controller General of India.
With these incredibly helpful rules having been set up this year, the clinical research industry is all set to boost, making India the next clinical trial ground for foreign companies. Use this opportunity to set up a successful career in clinical research by enrolling at Avigna Clinical Research Institute and getting the best clinical research training in Bangalore!
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Every Individual Involved In Clinical Research Is A Partner
The only purpose of clinical research is to find new drugs and devices to help improve the health of every citizen of the country, and even the world. Now, you may think how thoughtful it is for those clinical researchers to put out all their efforts and time into bringing up a medicine or medical device to help their countrymates. True it is that such professionals, after receiving the best clinical research training in Bangalore or any other such big city, put in years of efforts to come up with such effective yet safe innovations to help the mass. But, have you thought about the individuals on the other side – those who risk their lives to get the clinical trials experimented on them? Yes, we speak here about those candidates who register themselves for such clinical trials to be performed on their bodies. While some may be patients themselves looking for an effective treatment, there are others who aren’t ill, but just want to help! Looking at both the sides, we can clearly say that not one, but people on both sides of the trials are superheroes in their own ways! One side has those people who put in years of efforts and practice to bring up an innovation, while the other side has those who risk their lives to help try out the innovations.
Professor Gagandeep Kang at the 14th International Conference
This is the reason why Professor Gagandeep Kang, Executive Director at the Translational Health Science and Technology Institute, has said, “Everyone who participates in clinical trials is a partner, and should be deemed as champions of the cause, and hence it is the responsibility of us professionals to serve these people to the best of our ability. Without their trust, the advancement of both clinical science and medical practice would falter.” Being a professor, she has addressed the goodness of those candidates participating in the trials. She said this at the inaugural session of the 14th International Conference on Public Policy and Management, organized by the Centre for Public Policy at the Indian Institute of Management Bangalore, which was held from August 22 to 24, 2019.
The current standards of clinical trials
Professor Kang further said that clinical trials need to be carried out very responsibly and ethically, based on the relationship of trust with the participants, where total understanding is given, and the findings are shared with the communities. She confirmed that there are regulatory bodies to raise the standard of clinical research and curb unethical practices, but yet even though there are very good basic biology institutes, investment is still not up to the level that it should be. She also said that the factors that have worked so far in the domain include identification of needs in public health research, partners who provided appropriate training, targeted and monitored mentoring, commitment to the communities that professionals work in, commitment to quality, building multidisciplinary research groups of young faculty, availability of academic positions and funding, and working in collaboration with the government and like-minded institutions. But, more investment is definitely needed. There is also a lack of value systems, sclerotic bureaucracy, hierarchy, restrictive policies, and institutional support, which have proven to be some of the challenges of clinical research. She also added, “Going forward, we need to focus on setting priorities, looking at evaluating effectiveness, access, and healthcare management. As academicians, we need to help the Government in setting priorities, carry research, translate results into practice in India, and extend and reinforce research and training. High quality clinical research is being and can be done in India. Policies can be changed with planning and evidence accumulation”.
Going forward with the flow and success of clinical research in India, you can also join in on either side – a researcher or a candidate. To become a researcher, you need the best clinical research training in Bangalore from a reputed institute like Avigna Clinical Research Institute; while, to become a candidate, you can register online.
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ICMR To Set Up Clinical Trials To Bring Down Costs Of Drugs
The Nipah virus outbreak that was observed in Kerala was a nightmare, and has thrown several challenges that need to be addressed. Recalling the adverse effect of the outbreak, Dr. Chandni Sajeevan, professor and Emergency Medical Relief Head at Government Medical College, Kozhikode, said that everything came to a standstill and it hit the economy very badly.
Need for setting up clinical trial centres
In containment of this outbreak, Dr. R R Gangakhedkar, head of the Epidemiology division at the Indian Council of Medical Research (ICMR), said that the virus episode was a learning experience on their preparedness. The challenges faced during the Nipah virus outbreak has addressed the need for setting up clinical trial centres in the country and region, and further raise the levels of preparedness. He also admitted that the new drug development in India was still weak; thus, there was a need for government centres to set up a permanent unit to test the drugs. Considering this, the ICMR decided to set up a clinical trial platform at both the regional and national level to evaluate new drugs.
August 26-27
August 26 and August 27 will see a merging of all medical research councils of the region to propose the concept of setting up a regional clinical trial platform for research. Taking into account the Nipah virus outbreak, India will want to take a lead for monoclonal antibody testing to neutralize the virus, which will require samples. But, the samples will be fewer in India as the occurrences are few; thus requiring to take up samples from a country that has more prominence of the virus, like Bangladesh. The ICMR has established 11 Phase-I clinical trial units, and is considering on setting up another 4 Phase-II and Phase-III clinical trial units. Setting up such a regional platform will help resolve issues related to the emerging diseases in the region, rather than waiting for other developed countries to come and help with the interventions. This is one important measure that can also help in bringing down the cost of drugs and encourage the Make-In-India initiative.
One Health Centre in Nagpur
In addition to the above, a “One Health” centre will soon come up at Nagpur as part the ICMR-NIV effort, with an aim to address emerging zoonotic infections and study animal-human interface. “One Health” is an initiative that seeks greater integration of human and veterinary medicine in areas like infectious disease control and translational medical research. Dr. D T Mourya, the Director of ICMR, told The Indian Express that the centre will bring together experts from veterinary sciences, biotechnology, and other disciplines, towards better surveillance of infectious diseases in animals to anticipate emergence of new zoonoses and to protect humans.
Join the league of clinical trials and serve your country to help them get the best medical aid for every possible disease. And for this, you need to get the best clinical research training in Bangalore from a prestigious institute like Avigna Clinical Research Institute.
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Why Are People Dying Of Muscular Dystrophy? Isn’t There A Solution?
Muscular Dystrophy (MD) is a genetic disease caused by progressive degeneration and weakness of the muscles, which arises due to mutations or deletions in the MD gene on the X chromosome, affecting any of its 79 exons. MD results in lots of problems like difficulty in sitting, standing, and walking. If children succumb to this problem, they can hardly live for 20 years. However, if they are lucky enough or have access to very good medical facilities, they may live up to 40 years, but now more than that. As per the WHO report, 1 in every 3500 people is affected with MD, with 54 babies being born every day with this disorder! With such high number of Indians (almost 8-10 lakhs) suffering from MD, it definitely calls for a good amount of attention!
Muscular Dystrophy – No treatment in India yet!
With such huge numbers of Indians suffering from the disease, there are only a handful who have the capacity to travel abroad and get the right treatment. Living in India, patients have a very small hope of getting treated because of the lack of drugs available; and bringing in drugs from countries abroad can be an extremely costly affair. There is no cure or treatment in India at present for this disease; in spite of the large number of people suffering from it. However, the disorder has now come into the limelight, which is why scientists in three different institutes in Kolkata and Bangalore (IACS, ICH, and DART) have started working on the development of a medicine to treat this disease. Out of the three, DART has already conducted a successful trial of an RNA-based molecule on a patient, with permission from the ICMR; and has also applied for further clinical trials of the same to the DCGI. But, this seems no good for those currently suffering from the disease. This is because, even if approved, the drug will only be available in the market in the next 10-12 years. After all, drug development is a very lengthy process, involving lots of trials and approvals.
Muscular Dystrophy – The expenses and extensiveness involved
Looking at this, the parents of almost every child suffering from MD want their child to be a part of these clinical trials with the hope of being treated effectively for the disease. These trials are the only hope for such parents and children. This is because there are many drugs available abroad; for example, the USA drug Exondy51; but such drugs cost Rs. 2-3 crores annually, with one injection being given per week, for 52 weeks! This amount is generally not in the range of an average Indian family. Moreover, the overall management of this disease is extensive, including checks on a regular basis from a wide range of specialists and constant investment towards travelling, accommodation, and medicine in upcoming novel therapies. Then, there are wheelchairs, hists, calipers, transfer boards, leg braces, knee braces, and all sorts of devices used by such patients to keep them at ease.
No one drug suits all!
Apart from all of the above, one other consideration to make is that there are nine different types of MD, with each targeting a different exon in the X chromosome. Thus, there can be no “one solution” for all types of MD. Every different type of MD requires a different kind of medicine; so you can imagine the huge costs involved in the drug development of each drug!
However, we cannot let lakhs of our countrymates succumb to death only because of one particular disorder. We strive to work towards achieving Made-In-India drugs to help such patients, no matter how much time or money it takes. Join hands and put in your efforts and knowledge too by achieving the best clinical research training in Bangalore from Avigna Clinical Research Institute, so that you are eligible to work with professional scientists in our country, and bring about a variety of positive changes in the health sector of India.
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Can Restenosis Be Prevented With The New Drug-Combination?
Heart bypass surgeries are one of the most common cardiac surgeries being performed across the country. Thousands of people are undergoing the surgery every year, 5-7% of whom succumb to restenosis within months of undergoing the surgery. Restenosis is the re-narrowing of a coronary artery after a blockage has been treated. There is an almost 50% chance of occurrence of restenosis in patients who undergo heart surgeries; looking at the risk of which a new patent-pending drug combination has been developed, which promises to prevent as well as treat the condition to reduce the risk for heart-surgery patients.
The new drug combination
After more than 20 years of research, hematologist Jagmohan Singh Oberoi has sought a patent on the drug combination. At present, there are a number of drugs that seem to prevent the issue, but they are unable to do so successfully, as they target to treat only half the problem of the blockage. So, as there is no medication at present that ensures 100% prevention of restenosis, but the new drug combination holds the potential to reduce the risk by 70-75%. However, the risk with expensive heart procedures, even if very small, still remains.
How is the new drug combination different from the current drugs?
The drugs that are currently used treat only 50% of the blood clot problem, known as thrombosis, by targeting only the heamoglobin part in the blood. They do not treat the non-haemoglobin part, which increases the risk of patients reverting into the blockage of the arteries after the treatment. On the other hand, in the new drug combination, the combination of two enzymes targets both the haemoglobin and non-haemoglobin parts of thrombosis, which increases the chances of complete recovery.
Why is the pending yet on hold?
The patent for the new drug combination is pending with the Indian Patent Office. After getting the patent, collaboration will be sought with big pharmaceutical companies to hold clinical trials of the drug combination. After all, the drug holds the potential to prevent restenosis cost-effectively, while saving lakhs of rupees of patients that may be required in the re-treatment of artery blockage.
How does clinical research play an important role?
All such new developments are possible only after a good amount of research; just like hematologist Jagmohan Singh Oberoi had to wait for more than 20 years to seek a patent on the new drug combination. So, there is a long wait for not only developing a new drug, but also for getting it approved, and then getting a patent on it. With all of this being such crucial tasks, it is important that researchers have the best professional assistance. If you aim to become one such researcher, or any other professional in the field of clinical research, you need to get enrolled at a reputed clinical research institute. Avigna Clinical Research Institute is one such establishment that offers the best clinical research training in Bangalore, which can help you achieve the best jobs in top CROs, Bio-techs, and pharmaceutical companies.
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Will The World Achieve SDGs? India Will Tell!
India has found immense success in fighting life-threatening diseases like tuberculosis, malaria, lymphatic filariasis, and more. With such success, the country is all set to play a vital role in determining whether new drugs, vaccines, and other prevention tools can be deployed effectively and affordably to eliminate all such diseases from the world! This amazing news has been declared by the Bill & Melinda Gates Foundation. India will play an important role in determining whether Sustainable Development Goals (SDGs) can be achieved. This was confirmed at a lecture organized by the Department of Biotechnology, Biotechnology Industry Research Assistance Council, and the AIIMS. This is all thanks to the amazing education and training that is provided by reputed institutes across the country. You can also attain such exclusive training at Avigna Clinical Research Institute, the best clinical research online training institute in Bangalore. So, if clinical research and healthcare is your passion, enroll yourself right away!
What was the lecture about?
The lecture was titled “Innovating for Impact: How India can lead in helping solve some of the world’s toughest health challenges”. It primarily focused on India’s potential in addressing global health issues, and the challenges and opportunities that lie ahead. This lecture was attended by global leaders from various domains, where they shared their experienced and interacted with the scientific community.
How has this been possible?
This has been possible due to India’s huge size and population that carries a major portion of the world’s disease burden. India thus will play a crucial role in biotechnology and artificial intelligence that will determine the manufacturing of newer tools and technologies, which can help the country achieve health equity, and take leadership in addressing global health challenges. After all, no other country across the world’s emerging economies has the same combination of world-class biomedical research, effective translational research expertise, capacity to design and implement highly powered clinical trials, and capacity to produce health products that meet the stringent regulatory standards of the WHO, other than India!
India and its healthcare challenges
India definitely has 1 million missing cases of tuberculosis, but it also has the opportunity to develop improved solutions for tuberculosis case finding and reporting, along with treatment adherence. Another challenge that the country faces is that of nutrition. But, the National Nutrition Mission has set the goal of reducing the percentage of stunted children from 38.4% to 25% by the end of the year 2022.
ALSO READ: India Has Begun The Clinical Trial Of A New Tuberculosis Vaccine For Adults
India’s collaboration with international partners
India is collaborating extensively with many international partners in new areas to deal with the emerging healthcare challenges. Considering the high costs involved with healthcare, the collaboration is important to be taken up for frugal innovations so that efficient and affordable treatment strategies, relevant to the developing world and emerging markets, can be brought about. After all, access to affordable health technology remains a massive challenge not just in developing countries, but also in the developed ones, where pressure on the healthcare budget is immense.
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Dulaglutide – How Safe Is This Diabetic Medication For Other Body Systems?
Diabetes is one of the most common health issues that people all over the world are encountering. Speaking of India, the country sees 10% of the total population suffering from diabetes. But, the shocking fact here is that almost one in every two Indians living with diabetes is unaware of their condition!
Diabetes is of two types – Type 1 and Type 2; out of which Type 2 is the more common form seen, with 95% of diabetic patients suffering from it. The Type 2 diabetes can be controlled with the help of proper nutrition, exercise, and weight management. But, there are also required certain kinds of medications to be taken often. One drug that is most commonly used to treat this kind of diabetes is Dulaglutide. Founded in 2015, the drug has been commonly prescribed to diabetic patients. However, there were still, until recently, clinical trials going on over the medication to check for its impacts on the urinary and cardiovascular systems.
Advanced clinical trials conducted for testing Dulaglutide
While the medication has been proven to effectively treat diabetes, the doubt was whether it had any negative effect on any other bodily systems like the cardiovascular and urinary tracts. The good news is that the medication has been found to be absolutely safe and effective against cardiovascular and kidney diseases too! The clinical trials being done on the medication involved 9900 people from 24 countries, for more than five long years! Ultimately, it was researched and determined that the drug reduced cardiovascular events and kidney problems in middle-aged and older people. In fact, cardiovascular risks like heart attacks and strokes were reduced by 12% in patients taking Dulaglutide injections, compared to people taking a placebo. The greatest benefit was seen for heart failure, with a risk reduction of more than 30%. In addition, the drug also reduced the possibility of the development of kidney diseases by 15%. Such incredible results can be obtained when our dedicated countrymen take up clinical research as their career option, and undertake professional courses at reputed institutes like Avigna Clinical Research Institute, to learn and obtain a legitimate diploma in Clinical Research Bangalore.
Why were advanced clinical trials conducted?
What made this study to be taken up was the fact that people with diabetes have seen to observe twice the rate of cardiovascular events like heart attacks and strokes, and up to 40% development of kidney diseases, as compared to non-diabetic people. The trial has clearly shown that Dulaglutide can safely reduce the risks of cardiovascular diseases and kidney diseases, while also improving diabetes control, and modestly lowering weight and blood pressure in middle-aged and old patients with Type-2 diabetes.
How does Dulaglutide work?
Dulaglutide is injected once a week in patients suffering from Type-2 diabetes to lower the glucose level in the body. It works by helping pancreas release the right amount of insulin, when blood sugar levels are high, slowing the emptying of the stomach after a meal, and reducing appetite and weight. The drug has shown good tolerance, modest weight reduction, low-density lipoprotein cholesterol and blood pressure, and a modest increase in heart rate. It is easily available in the Indian market, although being a little expensive. However, as long as it keeps your diabetes, heart rate, blood pressure, weight, cardiovascular system, and urinary system under control, there should be no issue paying a little extra for that one dose of injection; should there?
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India Has Begun The Clinical Trial Of A New Tuberculosis Vaccine For Adults
India is home to 1/4th of the world’s tuberculosis burden, which has given the country an opportunity to make huge strides in public health by becoming a global leader in tuberculosis research. Taking this initiative, a vaccine trial was launched on 15th of July 2019 by the Indian Council of Medical Research (ICMR), to prevent occurrence of tuberculosis among close contacts of a tuberculosis patient who are at high risk of contracting the disease.
The new vaccine – Phase-III trials
The most famous BCG vaccine trial had been undertaken decades ago, after which a Phase-III trial is being conducted now for this new vaccine, to come up with the first tuberculosis vaccine for adults, as the BCG vaccine available and tested is only for newborns. This step is a stride towards prevention, which will help in decreasing the burden of the tuberculosis disease. After a detailed landscape analysis of the available lead vaccine candidates, two potential vaccine candidates VPM 1002 and MIP were shortlisted for being taken forward through the Phase-III trial in healthy household contacts of sputum smear positive tuberculosis patient. This clinical trial will evaluate the safety and efficacy of these two vaccines in a single trial, against a control group with no vaccine. The study would enroll 12,000 healthy household contacts of sputum smear positive tuberculosis cases that are at high risk of contracting the disease. These contacts would be from 7 sites in 6 states, namely Delhi, Orissa, Tamil Nadu, Karnataka, Maharashtra, and Telangana. The trial has begun at the first site, and will subsequently be initiated at other sites too, with a goal to complete the enrollment within 7-8 months.
What experts said
Balram Bhargava, Secretary at the Department of Health Research and Director General at ICMR, appreciated the Government’s support and researchers involved in the trial, at the launch of the vaccine’s clinical trial. He said that the clinical trials are needed in India to prove that the vaccine is safe and effective, and can provide protection to Indian populations, where the disease is endemic. The ultimate goal of this trial is to develop a vaccine that can prevent active tuberculosis and be a part of large campaigns aimed at eliminating the disease. The clinical study can thus help in achieving this goal and significantly advance the global fight against tuberculosis.
Rohit Sarin, Director at NITRD, said that this trial is a much awaited one, which is why he promised to provide complete support in timely completion of the procedure. In fact, every statutory regulatory body of India has approved this trial, as per the Indian regulatory guidelines.
You can also become an expert in the field of clinical research by undertaking a professional course of diploma in Clinical Research Bangalore at a reputed institute like Avigna Clinical Research Institute. This will help you achieve a certificate that will bring to you a good job in the field in top CROs, Bio-techs, and pharmaceutical companies.
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How Many Diabetics Are Actually Aware Of Their Condition?
Diabetes is a disease that occurs when your blood glucose goes beyond its limit. The body produces insulin to help the glucose from the food get into your cells so that it can be used for energy. But sometimes, the body doesn’t make enough insulin, which keeps the glucose within the blood itself. Having too much glucose in your blood can cause diabetes as well as many other health problems. Remember, whether your diabetes value is too high, or it is only on the border, every condition and case of diabetes is serious!
India and diabetes
Almost 10% of Indians are suffering from diabetes today; and can you believe it, around one in every two Indians living with diabetes is unaware of their condition! Moreover, only half of those who realize that they have diabetes are able to manage their condition and bring it under control. This means that only 25% of diabetics in India are able to cure, or at the least, maintain their condition!
Variation in health system performance for managing diabetes among states in India – The study
This number of 25 has been brought up only after a good amount of survey and research done. It was a cross-sectional study of individuals aged 15 to 50 years, which was conducted by the PHFI, MDRF, and the Harvard School of Public Health, along with other international organizations. They used secondary data from the National Family Health Survey 2015-16 for the analysis, and concluded what has been mentioned above.
How can diabetes be identified?
Developed countries have their citizens undertake regular health checkups to monitor all their diseases, which even include non-communicable ones. We need to adopt this approach in India too, which will help monitor blood glucose levels, and thus keep a check on diabetes. Otherwise, in India, we only undergo a checkup when a health certificate is required; which is a very wrong practice. This clearly shows that we aren’t undergoing health checkups for our own sake, but only for the sake of clearing a document that can help us achieve something that we may want; like a visa, a job, or the like.
Diabetes is a silent disease, which is why one may not be able to realize that they are suffering from it. But, if you really want to keep a check, you will have to undergo routine health checkups and look for even the slightest symptoms so that they can be treated immediately and more effectively, before they reach a higher stage.
The future of diabetes in India
With the way that India is growing its diabetic population year after year, it seems like it will become the diabetes capital of the world in the next few years! In fact, the International Diabetes Federation has also estimated that by 2045, India will have more than 130 million diabetic patients across the country!
How can diabetes be treated?
Diabetes may, if left untreated, develop harmful cases like kidney problems, which may require transplant or dialysis. While this is a huge problem for the patients themselves, another fact is that we don’t have enough donors for the transplant as well. Moreover, the dialysis may cost at least Rs. 3 lakhs every year, which is almost unaffordable by a major percentage of Indians.
Diabetes can be of two types – one in which the body stops making insulin at all; and the other in which the body cells cannot use blood sugar efficiently for energy. While both these types of diabetes can be controlled with the help of dietary changes and exercise, the first type will require insulin, while the second type will require non-insulin medications. How all of this is found and implied, is all thanks to the hardworking clinical researchers and scientists. You can also become one of these highly esteemed individuals by undertaking professional online clinical research training from a reputed institute like Avigna Clinical Research Institute.
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Clinical Trials Being Taken Up In India For Cholera Vaccines
Cholera is a bacterial infection that causes diarrhea, which kills the patients within hours, if left untreated. If patients are diagnosed in time, and treated with antibiotics and other measures at an early stage, they can recover and get back to their normal lives, but if not, they may have to lose their life! Cholera infects approximately 2.8 million people, causing 95,000 deaths every year! In 2018, there was a global demand for around 100 million doses of cholera vaccine, but the supply was only somewhere around 20 million; so you can imagine the sad face of the outbreak!
Today, the world relies only on two suppliers for cholera vaccines – one from South Korea, and the other from India; but, the global demand for cholera vaccines is higher than the supply. This is why large-scale clinical trials are being planned to be conducted, and a Swedish-designed cholera vaccine is to be commercialized to help fight persistent outbreaks of cholera in India and abroad.
The Hilleman-Bharat pact
It is the Hyderabad-based Bharat Biotech that signed a pact with the New Delhi-based Hilleman Laboratories to speed up the development and clinical trials. Also, the manufacture of the new oral cholera vaccine needs to be accelerated for the drug to be supplied to low and middle income countries. This collaboration of Bharat Biotech and Hilleman Laboratories has been mainly done to address the global shortage of cholera vaccines, in the midst of the persistence of outbreaks in several states across India and Africa.
What is the pact about?
Under the pact, Hilleman laboratories have licensed to Bharat Biotech the vaccine designed by scientists at the University of Gothenburg, Sweden. The vaccine’s safety and capacity to produce an immune response to cholera has already been established by Hilleman laboratories through limited Phase-1 and Phase-2 clinical trials in Bangladesh. Bharat Biotech, thus, has to conduct larger Phase-3 trials and scale up the vaccine production process for commercialization, while also seeking a pre-qualification certification from the World Health Organization, to enable it to supply the vaccine through global funding agencies. The entire process may take somewhere around three years, but the capacity to deliver 50 million doses every year will resolve the uncertainty over supply.
Cholera widespread in India
In India, the highest risk of cholera is in Bengal. In fact, Ancient Asiatic cholera strains have also thrived in the Ganges delta, making Bengal very unsurprisingly the most highly affected state. In fact, almost 50% of cholera cases seen in India every year have been in Bengal. Next in line come Karnataka, Gujarat, Maharashtra, Punjab, Odissa, and Assam. With a goal to produce an affordable vaccine that improves access to millions of cholera patients not only in India, but worldwide too, the vaccine that is being tested could be a key tool in the Narendra Modi government’s Swachh Bharat Abhiyaan campaign, which seeks to improve the levels of sanitation, and the access to clean drinking water.
Get yourself the best quality online clinical research training from Avigna Clinical Research Institute to establish a career in the clinical research industry, so that even you can put in your efforts and inputs to help your country, and the entire world, fight many such conditions like the life-threatening cholera! And, if you are worried about the associated expenses, worry not, the Indian Government has launched a scheme called SPARC, wherein the government will fund interested clinical research students and give them a chance to work in at least 28 global universities!
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The Journey Of A Medicine – From The Mind To The Shelf
We all have been prescribed one or the other medication by a doctor. It could be an oral medicine, a syrup, an injection, or a vaccine. Whatever it is, all we do is get to the pharmacist, give him the prescription, buy the medicine, and gulp it down as prescribed. While we are undergoing the pain, all we think about is getting well soon; and once we are back to normal, we easily forget about the medicine that brought us back to our routine. For us, the pain that we go through while we are on medications is what is important; but, what about the pains that the researchers go through while developing that medicine for us? Have you ever wondered how that medicine was though about, developed, and reached the pharmacist’s shelf?
Well, now that you think about it, the journey of a medicine isn’t easy. It is always kept in doubt until it is approved to be safe, and sanctioned to be packaged and sold. Every medicine passes through a number of procedures called clinical trials to ensure their safety and efficacy. The reason that modern medical advances have helped millions of people live longer and healthier lives is the decades of investment in medical research.
What are clinical trials?
Clinical trials are experiments or observations done on human participants, designed for treating specific conditions or disorders. They generate data on safety and efficacy that are later analyzed by FDA to check whether they are safe and efficacious enough to be approved for market release. Once approved, the medical devices, medications, or injections are produced, packed, and sold. Clinical trial participation is completely voluntary, wherein participants are overseen at all times to ensure that there is fair conduct and no risk to their health because of the trials.
Why are clinical trials important?
Clinical trials can help detect diseases or conditions, and treat them by testing any new device, treatment, or procedure. They may also help to detect and prevent diseases by testing a vaccine. All in all, clinical trials help people control their symptoms and improve their quality of life by providing raised standards of treatment and improving health care.
How are clinical trials conducted?
This is where we come to the main part – how medicines go through their journey from mind to shelf. Once a thought comes into the mind of a researcher, a potential medicine, procedure, or treatment is discovered. These interventions are then tested in animals for pre-clinical studies, which are submitted to the FDA for permission to test in humans, if the test is successful in the case of animals. Once the permission is granted, the medicine undergoes four phases.
Phase 1 – The drug is first tested on a small group of 20-80 participants to evaluate its safety. Also, any side effect is looked for, and an approximate safe dosage is determined at this stage.
Phase 2 – The drug is tested in a larger group of hundreds to determine efficacy and further safety among a larger group of people of all kinds of castes, regions, skin, etc.
Phase 3 – The drug is now tested on thousands of participants for final confirmation of safety and efficacy, comparing it to other commonly used treatments.
Phase 4 – Once all these phases are complete, and the drug is found safe through all of them, the New Drug Application is submitted to the FDA to gain approval for marketing. The FDA undergoes rigorous evaluation and reviews all the information regarding the drug before approving it for marketing.
You can see how clinical trials play an important role in improving the health outcomes in India. And, it is also a lucrative career option for all those interested in medical research. If medical research interests you too, get enrolled with Avigna Clinical Research Institute’s online clinical research training course, and benefit from having a great career in top CROs, Bio-techs, and pharmaceutical companies.
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Drug Development And Digital Technologies
With extreme pressure on the clinical industry to reduce costs while exhibiting greater value, the Indian pharmaceutical industry needs to optimize drug development and delivery models, driven by data and new-age technology; and this can only be done by improving R&D efficiency. But, to do so, there is a need for radical reconstruction of the existing drug development ecosystem, which can be acquired by harnessing new digital technologies like AI, IoT, and automation to transform the drug development lifecycle that has been used since years.
Beginning of a technological awakening
The levels of productivity have been falling, the R&D pipeline has been drying, and the clinical trials are becoming increasingly complex. With all of this, technology plays a vital role to gain high economic value for newer treatments, and to enhance efficiencies, by boosting quality and lowering drug development costs.
With the increasing regulations and evolution of the pharmaceutical market over the years, the drug development and discovery industry has evolved as well. Thus, automation and digitization, like AI and machine learning, have proven to be integral parts of the processes. Such advancement in technology has shifted the focus from data generation to data analysis. The biological data is being produced at an exceptional rate today, to gather the relevant insights from which, pharmaceutical companies require faster data analytics systems, which can easily analyze vast amounts of complex data at a pace more speedy than ever before!
Real-world data also enables target-based drug discovery and development procedures today. Thus, it is now possible for pharmaceutical companies to leverage real-world evidence from sources like wearable devices, mobile apps, and electronic medical records for significant insights that can facilitate more medical breakthroughs.
Driving more value
Digital technologies can help companies develop better value proposition by operationalizing the drivers of patient value and achieving significant advances in study methods, which traditional methods cannot deliver. These technologies can unlock medical innovation by improving the way we can work with data. Realizing this, the pharmaceutical industries in India have also been experimenting with digital technologies to integrate them into routine drug discovery and development operations, so that significant value can be delivered to all the stakeholders.
Enhancing efficiencies
Automation technologies can radically fast-track compound screening and other aspects of R&D, while also boosting efficiencies. Significant benefits in terms of quality and compliance can also be achieved by utilizing the latest emerging technologies that can help us better capture better data, thus making us smarter and more efficient in the ways that we approach drug development. Hence, investing in the right technologies can help shorten cycle times by speeding up the delivery of information, thus accelerating the path to progress for pharmaceutical companies.
Boosting quality
With the help of the latest technologies like AI and IoT, the drug development industry is getting rapidly modernized and impacting delivery quality significantly. Using real-time process analytical tools helps to optimize delivery without any deviations. Therefore, if such technologies are applied at every step of the value chain, it can augment the overall quality and compliance of pharmaceutical products, while optimizing and accelerating the bench-to-bedside process of crucial medicines.
Cost reduction
The traditional drug development takes somewhere around 10-15 years and hundreds of crores of rupees for a medicine to reach the market! Moreover, the cost for developing a new drug doubles once in every decade. But, with the pressure to make drugs affordable, it is imperative to bring down these costs of drug development. And, the only solution to this is by harnessing technological advancements to bring down the associated costs of drug discovery and development.
Undergoing such a digital transformation is a great step, but is equally complex, lengthy, and resource-intensive. Pharmaceutical companies and CROs will need to overcome several challenges to realize the potential of digital technologies in clinical development. It is the CROs’ responsibility to enable such transformation by advancing inter-operable digital platforms and testing promising technology applications.
You can see how important the role of a CRO is. You can also attain powerful and responsible positions in top CROs, Bio-techs, and pharmaceutical companies by undertaking professional clinical research diploma courses in Bangalore from a reputed institute like Avigna Clinical Research Institute.
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How Are Poor Sleep And Poor Nutrition Associated?
Diet plays a huge role to determine a person’s health; we all know that. But, do you know that diet can also impact sleep quality? Yes, it’s true! Research has indicated that just one day of eating food low in fiber, but high in unhealthy saturated fat and sugar, can reduce the duration of sleep; thus affecting the physical and mental energy of a person. While poor sleep has been linked to poor nutrition, it is yet unclear why the two may be linked together, which is why research is being done on that aspect too.
It is a general rule that adults must sleep for more than seven hours every night to maintain their health. It has been found that people who sleep less than seven hours a day may lack adequate levels of vital nutrients. This is because they generally consume fewer nutrients like vitamin A, vitamin D, zinc, niacin, and more.
Another research has been done determining that a greater number of nutrients have been associated with poor sleep in women than in men. However, this number can be reduced if women take dietary supplements. In fact, any individual with short sleep duration may benefit from improving their intake of nutrients through diet and supplements. As a matter of fact, nutrients, other than affecting sleep quality, also play a role in sleep disorders and trouble falling asleep.
Micronutrients are important for our health; they are those vitamins and minerals that our bodies require, but aren’t produced naturally by the body. As a result, they must be added in our diet. Generally, billions of people suffer from one or the other micronutrient deficiency, which is why nutrients are added into their diet as supplements. Any deficiency of such micronutrients results in disruption of normal bodily functions, which may or may not lead to development of diseases or other problems. So, if you want to eliminate the risk of such sleep disorders and other potential body functioning problems, you must focus on the intake of proper micronutrients for your body. Supplementing with artificial additions to your diet can help fill the nutritional gap in your diet. There have been a number of studies that have demonstrated important roles for micronutrietns in growth, development, disease prevention, healing, sleep, and normal bodily functions. For example, magnesium helps the body produce melatonin, which helps with sleep; and zinc plays a role in sleep regulation.
Whether chronic short sleep causes nutrient deficiency, or nutrient deficiency causes short sleep, is yet to be determined. Whatever it is, the fact is that both sleep and nutrients are interrelated, which is why you must have a good diet full of minerals and vitamins.
Such research and many others are possible with the help and involvement of clinical research professionals across the country and the globe. Join the confederation and take up professional clinical research diploma courses in Bangalore from a reputed institute like Avigna Clinical Research Institute to help your countrymen find all sorts of discoveries and innovations related to health, make your country a better and healthier place to live in.
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