‘Institutions should do research in the midst of regular patient care’ | Mumbai news - Hindustan Times

‘Institutions should do research in the midst of regular patient care’

ByJyoti Shelar, Mumbai
Aug 29, 2021 11:52 PM IST

As Covid-19 pandemic may be entering an endemic stage, Hindustan Times spoke to Dr Sanish Davis, president of Indian Society for Clinical Research, on the research landscape in India or the lack of it.

As the Covid-19 pandemic in India may be entering an endemic stage, vaccines will continue to be the mainstay to deal with this viral disease. While that covers the prevention aspect, definite treatment options still elude the medical community, prompting the urgent need to boost indigenous research and investment in scientific processes. Hindustan Times spoke to Dr Sanish Davis, president of Indian Society for Clinical Research, on the research landscape in India or the lack of it. Edited excerpts:

Dr Sanish Davis, president of Indian Society for Clinical Research.
Dr Sanish Davis, president of Indian Society for Clinical Research.

Could India have done better in Covid-19 clinical trials and research?

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It would be easy to say we could have done better but we must look at the Covid-19 trials against the backdrop of the entire clinical trial environment in the country. In 2019, the New Drugs and Clinical Trials Rules were announced in India, a development that created a more robust regulatory framework for the conduct of clinical trials in the country. Prior to that, clinical trials in India faced very challenging times with activism, misinformation and regulatory uncertainty, resulting in a significant drop in clinical trials done in the country. Clinical trials were beginning to pick up but the pandemic hit and it temporarily halted this progress. The focus turned more towards Covid-19 trials and rightly so.

In 2019 we were doing around 4% of global clinical trials in India and that number has since dropped to less than 2% overall (industry-sponsored Covid and non-Covid research). India has the second-highest population in the world and the highest disease burden; so, the percentage of clinical trials in India is nowhere near what we should be doing. However, we must also take pride in the research and development work being done in India in the fight against the pandemic which has resulted in the discovery and development of both drugs and indigenous vaccines.

Is the Indian scientific community well equipped and trained to design and conduct good quality clinical trials?

India has an abundance of high-quality research talent, world-class sites, a large and diverse patient pool and perhaps one of the most stringent clinical research regulatory environments in the world. Ultimately, the real quality of our research will be demonstrated in audits and inspections, and I am happy to say the findings of such inspections will validate the high quality of clinical research being done in India.

What are the shortfalls or areas of concern in the Indian clinical research environment?

More than shortfalls, we see opportunities. The pandemic has helped us look at clinical trials in a new paradigm and highlighted the importance of two major aspects — how digital adoption can advance and hasten the clinical trial process without compromising on quality, safety or patient centricity, and how collaboration across stakeholders will aid safe, secure and conducive ecosystem of trials. Institutions should be sensitised about the importance of doing research in the midst of regular patient care. There is also a need to reach out to a vast swathe of population to help them understand the importance of clinical trials.

A recent opinion piece in the British Medical Journal highlighted fake trials or what are known as zombie trials. What is the extent of such fraudulent trials in India?

In most cases, fake or zombie trials can be traced to independent trials. However, the number of such trials is almost negligible. Much like any other service industry, you will have players operating at both ends of the spectrum and it is important to note that fake or zombie trials are clearly an exception rather than the norm.

There are two broad types of clinical trials — regulatory and academic. Regulatory clinical trials require three main components — approval of the Drugs Controller General of India (DGCI) or Central Drugs Standard Control Organisation (CDSCO), scrutiny of the Subject Expert Committee (SEC) for approval to conduct the trial and registering the trial in the Clinical Trials Registry of India (CTRI), an open-source public information platform hosted at the Indian Council of Medical Research’s National Institute of Medical Statistics. Due to the above protocols, the chances of a fake trial or unsupervised trial are highly unlikely.

Most countries have a debarment list, a kind of blacklist that features researchers or organisations that have indulged in fraudulent practices. Isn’t it important for India to have such a list?

Undoubtedly, a blacklist or a debarment list is important and required. In the US, a debarment list is maintained by US Food and Drug Administration (USFDA). This list is accessible to pharmaceutical companies and contact research organisations to verify if an investigator they want to work with is on the list.

In India, the National Medical Commission (erstwhile Medical Council of India) for academic studies and CDSCO for regulated trials should maintain a debarment list. CDSCO does regulatory inspections at sites and hence they are well placed to constitute, review and update the list. This will increase the confidence in the clinical research ecosystem in India and will also ensure an additional layer of checks and balances for all stakeholders of clinical research, including patients.

What has been ISCR’s contribution to encourage and promote good quality research during the pandemic?

The pandemic has played a catalytic role in driving more digital adoption. We have collaborated not just with the regulators but also with all stakeholders to embrace these new changes through workshops, direct discussions and training sessions. The opportunity to do things virtually has also led to an incremental increase in the number of training sessions and webinars organised by our various councils which have been extremely well received.

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