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Clinical trials in India: COVID-19 pandemic crisis and beyond

Dr. Chirag Trivedi
Thursday, August 6, 2020, 08:00 Hrs  [IST]

More than ever before, clinical trial has generated a lot of interest during the times of COVID-19 pandemic crisis. All over the world, people are waiting anxiously to get a drug that can cure this dreaded disease or a vaccine that can prevent it.

Tremendous amount of research is currently ongoing to find out a safe and effective treatment for CVOID-19 be it for repurposing the existing drugs or finding newer drugs and vaccines. All this is happening at an incredible speed!

As one may be aware, the entire process of clinical trials (also called as the clinical development phase of the drug R&D process) is long, arduous and costly. Today, on an average it takes approximately 8-9 years for a molecule to reach from the lab to the patients of which clinical development phase takes the longest time. Also, it takes more than US $2 billion to develop a drug globally!

Today, researchers are working at top speed to get an effective treatment or a vaccine against COVID-19. One can imagine how fast this entire machinery must be working now to get a treatment option for COVID-19 in a record time!

Evolution of clinical trials in India
We have been conducting clinical research studies in the country since many decades. However, in the last decade, clinical trials in India has had its own share of ups and downs. From conducting more than 500 trials in 2010, it nose-dived to only 107 total trials (including 17 global clinical trials) getting approved in 2013 - which was the hardest hit year for clinical trials.

In 2013, due to an ongoing Public Interest Litigation in India, many changes to the rules governing clinical trials in India were introduced. This led to a significant slowdown in the clinical trial activities in India. While some rules introduced in 2013 were welcomed by the stakeholders, for e.g., the registration of the Ethics Committees, certain other rules introduced then were against the basic tenets of clinical trials. This resulted in a significant slowdown in the number of clinical trials conducted in India.

Persistent advocacy efforts were made from different stakeholders of which Indian Society for Clinical Research (ISCR) played a lead role. A continuous dialogue with the ministry, regulators and policy makers was undertaken to emphasize how the rules introduced in 2013 were impacting drug development in India.

All the stakeholders recognized that India needs to conduct quality and ethical clinical trials to find newer treatment options for the unmet medical needs of our patients. Thus, these continuous interactions resulted in the subsequent amendment of the rules which made it balanced.

This led to the New Clinical Rules that were released in 2019. These new rules are well-balanced. It protects the rights, safety and well-being of the clinical trials participants and at the same time, makes it convenient for the researchers to conduct good quality and ethical clinical trials. Today, we are observing a steady increase in the number of new clinical trials approved in India.

Do we have enough clinical research in India?
The simple answer is no. Analyzing a global clinical studies registry www.clinicaltrials.gov (where the global clinical studies are registered before they are initiated) which registers interventional and observational (non-interventional) clinical studies, it can be seen that India has less than 1.2% of the total number of studies that are registered on this site. As of June 26, 2020, globally 343,915 studies are registered on this registry.

India is the second most populous nation in the world and has almost 1/5th of the global disease burden. With conducting less than 1.2% of the clinical research studies of the world, India must significantly increase its activity for this and take that quantum leap in this decade!

How to enhance clinical research capabilities
It is well known that while clinical trials help in finding newer treatment options for our patients, clinical research has several other benefits to our country, some of which are listed below:

It gives a chance for patients to participate in clinical studies that help in deriving a better understanding of the diseases and their outcomes.

Additionally, it helps patients to participate in clinical trials to evaluate safety and efficacy of newer treatments, technologies and interventions which otherwise may not be available to them until they are marketed.

It helps to develop the healthcare infrastructure across all stakeholders for e.g., Biopharmaceutical industry, CROs, hospitals, supply chains, etc.

It helps to develop cutting-edge science and technology in our country for treating patients.

It gives a boost to drug research and development in our country.

It utilizes the available professional talent pool and develops it further.

It helps to develop new skills; generates employment opportunities and attracts foreign direct investments.

As mentioned earlier, now that we have a stable and well-balanced regulatory regime, it is clear that India needs to up its efforts for having more clinical research in the country since the patients are waiting.

All the stakeholders – for e.g., the government, policy makers, the regulators, the biopharmaceutical industry, the contract research organizations, the doctors (called as Investigators in clinical research), the para-medical staff at the hospitals, the Ethics committees, etc. – need to work together to build the required ecosystem necessary for the increased activities that we foresee. It is also incumbent on the stakeholders to develop the talent required for this.

Large scale capacity building coupled with increase in clinical research awareness and constant advocacy will also help us to realize these goals.

Will COVID-19 hold us back?
Again, the answer here too is no! To say that COVID-19 is posing a variety of challenges to the world is clearly an understatement! The depth and expanse of difficulties that this disease is throwing at the world is unprecedented! Listening to experts, it is clear that these challenges will well run through 2020 into 2021 until we get a cure and a vaccine – available all across the world – that will help us fight it!

For clinical trials too, COVID-19 pandemic posed several challenges. Due to the lockdown, the patients were unable to visit the hospitals, the hospitals were overwhelmed with COVID-19 patients, the doctors became busy in managing COVID-19 patients, and the availability of hospital staff and the site study team members was restricted.

However, COVID-19 crisis generated a lot of positive new things for clinical research!

Managing patient safety and of the hospital staff and the clinical trials teams was of paramount importance and hence, during these challenging times too, the clinical trial sponsors and CROs employed many innovative initiatives to have as minimal disruptions to clinical trials as possible. To name a few:

If the patients were unable to visit the hospital sites, direct to patient shipments were initiated wherein the clinical trial drugs were shipped directly to patients’ home, ensuring all the quality and patient confidentiality parameters. This helped the patients to continue taking their trial medications without any disruptions.

Use of telemedicine and virtual mediums by the doctors to evaluate safety and well-being of the trial patients.

Remote monitoring of data by the trial sponsors and CROs to ensure data quality.

What the future holds?
The use of technology in clinical trials has tremendously increased. This will continue in the future too even when this pandemic gets over. We need to conduct our trials faster and at the same time maintain quality. Also, it should also be convenient for the patients and all the stakeholders. Technology will surely help us to do that.

Going forward, learning lessons form COVID-19, we need to make our study designs, conduct, analysis, and reporting catastrophe-proof. Our future clinical trials will need to have the inbuilt necessary safeguards and processes to ensure that no disruptions happen to the patients’ safety or trial integrity, if such things were to happen again. Additionally, it should also offer the flexibility to assess the patients’ safety and efficacy remotely by employing the required parameters. As can be seen, taking that quantum leap in using digital technology for clinical trials will become the new order!

Finally, all stakeholders will need to significantly enhance clinical studies in India because the patients are waiting for newer treatment options for their diseases!
(The author is senior director, Clinical Study Unit Cluster Head, India-South East Asia, Sanofi President, ISCR.)

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MONKAM Feb 16, 2021 4:29 AM
Dear Madam or Sir,

I'm looking to make a preclinical test of a drug combination on Covid-19. Is it possible with Pharmabiz or can you send me some address which I can contact ?

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