“Need greater awareness on clinical research in India”

The Indian Society for Clinical Research (ISCR) is an association of clinical research professionals which aims to build awareness of clinical research as a specialty in India and to facilitate its growth in the country. In an exclusive interaction with the BioVoice, Dr Chirag Trivedi, President, ISCR shared his perspective on the clinical research scenario in India. Read on:

Why is the International Clinical Trials Day relevant to India? How does ISCR celebrate the day?

India has 17% of the world’s population and 20% of the global disease burden and yet, less than 1.3% of global trials take place in India. We need greater awareness created about clinical research so that patients are aware of their rights and responsibilities. We need to encourage more innovation and research and development in India to make Make in India a reality for clinical research. We also need to ensure that global stakeholders are aware about the balanced regulatory environment we have in the country today. More clinical trials in India will mean that more patients can access the benefits of more effective and newer treatment.

We will continue our theme of Patients First in 2018 as well. The theme acknowledges the selfless contribution and our appreciation of clinical trial patients in bringing new drugs and new treatment to market. It is also dedicated to patients who are still waiting in hope of a better quality of life made possible through new treatment and to whom we commit the work we do as clinical research professionals.

We commemorate the day with a host of activities organized by our various Councils and members across the country. These include seminars, training session, awareness sessions, roundtables, media engagements, etc.

How do you look at the current clinical research market in India? How big is the market size and what is its growth potential?

During 2013-2014, India witnessed significant challenges for conducting clinical trials. Certain new regulations introduced in 2013 had certain contentious clauses that were against the basic tenets of clinical research.

Subsequently, ISCR and a few other stakeholders made a series of representation to the Government and Regulators to make the regulations more scientific and balanced. From 2015 onwards, these regulations were amended. Today, our clinical trial regulations are more balanced – they ensure that the rights, safety and well-being of all the patients participating in clinical trials are protected and at the same time allow clinical researchers to conduct good quality, scientific clinical studies in India.

Currently – based on the data available in the global clinical study public registry – India is conducting less than 1.3% of the global studies that are registered. At its peak (in 2010), India was involved in only 2% of the studies that were conducted globally. Looking at our huge disease burden, it is imperative for India to conduct more clinical studies which will help us develop drugs for the unmet medical needs of our patients.

What has been the prevalent scenario for CRO business in India during last 5-6 years? Has it recovered from the earlier setbacks? can it really recover its lost sheen?

The challenges during 2013-14 (that were mentioned earlier), led to a VUCA (Volatile, Uncertain, Complex, Ambiguous) environment for conducting clinical trials in India. The clinical trial approval timelines were unpredictable then. The trust deficit increased during that period. All these factors led to a drastic decrease in the number of global clinical trials conducted in India. Even reputed institutes like the NIH of USA stopped conducting their studies in India. Subsequently, as mentioned earlier, from 2015 onwards when the regulations became more balanced, the confidence of the global community started to get revived and the number of global clinical trials approved in India started going upwards.

Have you done any awareness programmes with researchers/scientists to sensitize public about the importance of clinical trials for drug discovery and developing new medicines?

Yes. Since its inception, ISCR is committed to capacity building for clinical research professionals and institutes in India. In over a decade, we have conducted more than 200 training programs which has included more than 10,000 attendees spanning across hospitals, doctors, para medical staff, sponsors (pharma companies and institutions), CROs, Ethics Committee members, etc. These trainings cover a variety of clinical research related topics which are tailored for the audiences.

As an association, how often have you been able to discuss and convey the suggestions to the government/regulators? What has been the outcome?

Over the last more than a decade, ISCR has been increasingly established itself as a value-added partner to the Government and Regulators for providing inputs on clinical trial related policies and regulations. As mentioned earlier, ISCR played a key role in getting the regulations – introduced in 2013 – amended, to make it more balanced. ISCR is included in all key stakeholder consultation meetings that are held by the Government and Regulators and we are appreciative of the collaborative approach adopted by the regulators particularly in the last few years.

How many clinical trials have happened in India in last few years? Should we expect an increase in the numbers in next few years? What is your future outlook on the Indian CRO industry?  

The number of global clinical trials approved in India during 2013, 2014, 2015, 2016 and 2017 approved by DCGI are 17, 70, 54, 37 and 97 respectively.

With more balanced regulations in place now and with improved predictability, clarity and certainty in the regulatory environment that we are currently witnessing, it is expected that the number of global clinical trials in India is going to increase. The trend of the number of global clinical trials approved in the last 4 years, confirms this.

Having said this, the new Draft Rules on Clinical Trials that were published earlier by the Ministry of Health and Family welfare earlier this year for consultation, have certain contentious clauses for e.g., based on the Ethics committee’s decision, providing an interim compensation of 60% that is non-refundable, or providing medical management and ancillary care for as long as required, whether the adverse event is related or not to the clinical trial.

We have given our recommendations for these critical observations to various authorities. If these rules are notified as is in the current draft, then it has the potential to derail the conduct of the global clinical trial in India and it will take India back to 2013 days, wherein the global sponsors (including leading academic institutes) will not want to conduct clinical trials in India. This will have a direct correlation of these drugs not being introduced in India and our patients will get impacted by it.