We are the second-most populous country in the world and we carry the world’s largest disease burden, yet less than 1.4% of all global clinical trials are done in India. To address unmet health problems and to control the growing disease burden in the country, we need to scale up clinical trials, specifically investigator initiated trials, to increase the effectiveness of existing interventions and find new indications for approved drugs.
Also known as academic trials, investigator initiated trials are clinical trials where the sponsor is not a commercial entity, as is the case in industry sponsored trials. A sponsor-investigator is an individual who both initiates and conducts an investigation, taking on the regulatory obligations of both. Investigator initiated trials are unsolicited research studies independently proposed and conducted by institutions, physicians and researchers. These are non-commercial, patient-focused and are targeted at improving or expanding existing, approved therapies to address unmet health needs, instead of discovering new interventions.
So, why do we need investigator initiated research in India?
Investigator initiated clinical research allows us to focus on disease areas that are widespread but might not be the industry focus. For example, when it comes to cancer, the industry focus is on breast cancer, lung cancer, prostate cancer and melanoma. However, the most prevalent cancers in India are those of head and neck, cervix, breast, esophagogastric and gall bladder. We need to conduct investigative research with existing drugs to find more effective treatments for these cancers.
We have underestimated investigator initiated clinical research and its benefits for patients. A case in point is a 1998 Mumbai study which investigated the efficacy of using visual inspection with acetic acid (VIA) to reduce cervical cancer mortality. Cervical cancer is the leading cause of cancer mortality and Pap smear screening is not always feasible. The study found that an easily implementable strategy like VIA screening could prevent 22,000 cervical cancer deaths in India and 72,600 deaths in resource-poor countries each year. There are several such examples of investigator initiated research products that do not require thousands of dollars in grant money and are easily implementable in India.
Regulatory reforms for clinical trials in India
The last few years have been challenging for clinical research fraternity. Over the last year, however, there was a thoughtful effort made by regulators to bring clinical research in India back on track. Earlier this year, in an effort to streamline clinical trials, the Indian Council of Medical Research said it would look at revisions in its guidelines to create a conducive environment for such trials. The most recent development is the amendment in the Drugs & Cosmetics Act that exempts academic institutions from taking prior permission from the Drug Controller General of India for clinical trials. Now, the ethics committees of medical institutions and hospitals will be able to authorise academic research, shortening the approval process.
However, there are regulatory and other challenges that still need to be addressed. For example, several limitations still exist that either delay academic clinical research or curb its scope. While the approval processes in place are necessary from a safety perspective, we can expedite these processes while retaining the same level of precaution and safety. For instance, international collaborative research requires clearance from the Health Ministry’s Screening Committee thrice a year, resulting in a long delay. There are limitations on human specimens leaving shores, which have a major impact on the breadth of collaborations with international researchers. Finally, training in research is not an integral component of undergraduate and postgraduate medical school curriculum. A recent study on the quality of medical research in India published by the Current Medicine Research and Practice reported that nearly 60% of the 579 medical institutes in India have not published a single research paper in the last decade. The lack of incentives for research in medical school curricula not only puts our students at a disadvantage compared to their international counterparts, it also deprives our patients of potentially benefiting from academic research.
If we have to tackle India’s unmet medical needs, we need to make clinical research work for our country. Academic and investigator initiated research is an imperative, not merely an option. The government has provided certain exemptions which will encourage academic research. In fact, academic research has the same stringent local and international guidelines as research by any sponsor in the country and with equal commitment to patient safety, ethics and quality. I have witnessed the tremendous benefits that cancer patients at my hospital have derived from local academic research, both in terms of cost and efficacy. The environment for clinical research in India has taken a positive turn and we must keep up the momentum and continue to engage in efforts that will facilitate the growth of investigator initiated research.
The author is professor and chief, thoracic surgery, Department of Surgical Oncology at Tata Memorial Hospital