“Over 200 active clinical studies underway in India”

The fast tracking of clinical trial approvals and shortening of regulatory timeliness in vaccine development have been very positive for the clinical research industry, believes Dr Sanish Davis, President, Indian Society for Clinical Research (ISCR). Dr Davis predicts that Indian clinical trials market would grow at a compounded annual growth rate of 8.7% from the period 2017 to 2025 to reach USD 3,125.16 million by 2025.

In an exclusive interaction with Rahul Koul, Chief Editor, BioVoice, Dr Davis shared his views on a variety of issues including the impact of ongoing pandemic, latest current clinical research scenario, policy and regulations, challenges and opportunities besides the overall future outlook. Read the detailed interview below:

What has been the impact of the COVID-19 pandemic, both positive and negative, on the clinical research industry? Any key learnings to be implemented in near future?

The COVID-19 pandemic has had a catalytic effect on several areas of clinical trials that we have been in discussion on for several years now. Most importantly, it has shown us how collaborative efforts across all stakeholders including the regulators, sponsors, CROs, investigators and ECs can lead to expedited clinical trials without compromising on patient safety, ethics or quality. This was possible through digital adoption in some of the processes as well as incorporating processes that allowed for clinical trials to be conducted in a virtual environment. Clinical trial protocols were amended to accommodate the flexibility that was required to mitigate the pandemic induced risks. The Regulators and the Ethics Committees accorded priority review for such amendments. These measures, while in no way reducing the rigour and robustness of the clinical trial process, resulted in reduced approval timelines and some virtual processes which further reduced clinical trial timelines.

The other positive outcome has been that discussions around clinical trials in traditional and social media have led to much more awareness about clinical trials amongst the general public. However, it is important that there is context and background around these discussions so that a naïve person is able to understand the clinical trials in the appropriate context.

Will the fast-track approvals and shortening of regulatory timelines in case of COVID-19 vaccine development lead to any definitive changes in coming times?

Yes, there is no doubt that the fast tracking of clinical trial approvals and shortening of regulatory timeliness in vaccine development have been very positive for the clinical research industry. They have shown us what is possible if we have the will and commitment. It is important that we incorporate lessons learned from vaccine development into future development of not just vaccines, but all treatments and therapies. This will be of immense benefit for countries like India which has the highest disease burden in the world and several unmet medical needs. Of course, while doing all of this, it is important we continue to ensure that patient-centricity is at the core of all developments.

Has the CRO business in India recovered from its earlier setbacks? Can it really recover the lost sheen?

Several of the regulatory issues we had in the past have been addressed with the New Drugs and Clinical Trial Rules in 2019 and the regulatory system is now more robust and predictable. This has helped to a large extent in reassuring global stakeholders in particular about the commitment of the India government in ensuring a more conducive environment in India for the conduct of clinical research. Increasingly, global sponsors were able to include India as part of the clinical trial footprint from 2020 and this was reflected in the general buoyancy seen in the number of trials being placed in India in 2020.

The pandemic has however impacted the growth and while we have seen several COVID-19 clinical trials being done in India, it will take time before we are able to return to a pre COVID-19 threshold. India is a significant market globally and global sponsors would definitely want to include India as part of their global programs as this ensures that Indian patients gets the benefit of participation in research of a new molecule for as unmet medical need and, at the same time, it also paves the way for marketing authorization for medicines at the earliest if the medicine/vaccine/medical device has the appropriate safety and efficacy.

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

India accounts for nearly 16.0% of the population worldwide and nearly 20% of the disease burden across the globe, yet less than around 1.4% of total global clinical trials are conducted in the country. While there is no database maintained in publicly accessible locations that tracks the industry, based on market estimates and forecast, the Indian clinical trial market size was estimated at USD 1,897.43 million in 2019 and is expected to reach USD 2,064.30 million in 2020. India accounted for an 8.3% share of the global clinical trials activity in 2020. The Indian clinical trials market is expected to grow at a compounded annual growth rate of 8.7% from the period 2017 to 2025 to reach USD 3,125.16 million by 2025. While it is difficult to validate these numbers, it can be safely stated that there is definitely an uptick in the number of clinical trials done by the pharmaceutical industry. Infectious Disease was the leading therapy area for industry-sponsored clinical trials in India in 2020 with approximately 30% share.

It is a well known that there were several clinical trials for COVID-19 therapeutics and vaccines being done in 2020 and continuing well into 2021. Oncology studies also showed a steady increase in numbers from 2020 and several sponsors and CROs are bringing their oncology portfolio of work to India.

Please take us through the current key industry trends globally and in India? What is your future outlook on the Indian CRO industry?  

Globally, clinical trials has seen wider adoption of digital technologies in clinical trial conduct e.g., direct to patient shipment of medicinal products, home healthcare nursing, walk in clinics which are remote from the site but close to the patient’s location, use of digital biomarkers, e-informed consenting, e-health record directly feeding data to the e-CRF, etc. Diversity and Inclusion are currently big themes in global drug/clinical development. While the meaning of diversity and inclusion can vary between developed and developing countries, the intent is in the right direction and it is to offer clinical trials to under-represented communities, regions etc.

With the increasing penetration of mobile and internet services from a current 388 million users with 4G network enabled, India can only lead the way in implementing tech-driven clinical trials. Remote-based, decentralized trials with patients participating in clinical trials from the comfort of his/her home would also be a big advantage in a country like India and in 2020, we have seen the regulators and the Ethics Committees agreeing with this approach. We are hopeful that this will continue in the post pandemic future too. Additionally, we will also get to see adoption of increasing patient-centric approaches for designing and conducting clinical trials.

The pandemic has certainly put more focus on Infectious diseases, vaccine and diagnostics as areas which need more research to be carried out. India has a fair share of communicable and non communicable diseases and would have to balance investments in R&D to ensure that patients are benefitted across the spectrum. While investments in oncology R&D will continue to be key for several sponsors, there is also the resurgence of interest in other areas.

Models like virtual trials/decentralized trials have gained momentum with the pandemic but it will take time before these become mainstream and the go-to model for operationalizing clinical trials. ISCR will collaborate with stakeholders to build the ecosystem for this in India and a lot of it would be in the form of sensitization and socialization of the concepts of virtual/hybrid trials with different stakeholders

How many clinical trials have happened in India in the last 2 years? Should we expect an increase in the numbers in the next few years?

At present, there are over 200 active clinical studies underway in India. Given the country’s high disease burden, that number is extremely low. I believe we will continue to see an increase in the years to come.

In the post pandemic period (2022 and beyond), there will definitely be a continuing increase in clinical trials in India. After the release of the New Drugs and Clinical Trials (NCDT) Rules 2019, the regulators and the Ethics Committees in India accorded priority review for the amended clinical trial protocols during the pandemic period. In fact, the regulatory agency and Ethics Committees adopted the digital way of working in a major way. It is crucial that these steps should be continued in 2022 and beyond for India to continue to have a seat on the table in the global clinical research community. The rising confidence of both in-country teams and  global principals in pharmaceutical sponsor firms and CROs will also ensure that more work is placed in India going forward.

Any initiatives to sensitize the public about the importance of clinical trials for drug discovery and developing new medicines?

Yes ,public education and awareness is an important focus area of ISCR’s. While the pandemic has been a catalyst in enhancing awareness about clinical trials, it is important that this is understood in the right context and against the right background. We seek the media’s support in driving this agenda with us.

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

An important stakeholder and partner in our outreach has been the government and regulators. ISCR’s Regulatory Council is in regular contact with the regulators and pain points of the clinical research industry is discussed. While there is a sincere effort on the part of the regulatory agency and the government to come up with pragmatic solutions which benefit the ecosystem, there is also a strong emphasis on upholding and enhancing patient safety in clinical research.

The implementation of the NDCT Rules in 2019 has been one of the best confidence building measure that the government/regulators have given to the clinical research industry. Two years post implementation of the Rules have shown that there is very evident signs as well as increasing confidence that the rules are enabling the growth of the industry at the same time ensuring patient safety. ISCR continues to engage with the regulators and government to provide feedback and enter into a discussions in areas which can be improved (for example the SEC functioning) which can usher in more clinical research to be conducted in India.