Clinical research hits a roadblock as the number of trials decreases significantly over the last four years.
The recent orders on various aspects of clinical trials from the Central Drugs Standard Organization (CDSCO) have not been able to satisfy the stakeholders in the clinical research industry. Experts have termed these as mere regulatory in nature and not in sync with reality or current requirements. Only positive point they say, is that there is at least some movement in terms of issuing orders.
"Clinical research in India should be reflective of the country's ever increasing healthcare needs," said Ms Suneela Thatte, president, Indian Society for Clinical Research (ISCR) at a panel discussion held in Delhi to discuss the clinical research environment in the country today. "The growth in the industry, which peaked from 2005 to 2010, has seen a massive decline in the last few years, due to widespread misconceptions and the uncertain and unpredictable regulatory environment. We need to ensure that enough research is being done in India to address our triple burden of diseases which include communicable diseases, non-communicable diseases related to lifestyle and infectious diseases."
As per Dr Shamsher Dwivedee, senior consultant neurologist, Fortis Memorial Research Institute, "Those who are criticizing the trials don't understand the suffering of the people and forget that it is a human issue. I have a case where a patient was willing to even travel abroad for trials because there were no such opportunities in India."
"Over a period of time, there has been a decrease in the number of trials. From 2010 onwards, there has been a five fold downturn in trials owing to the negative environment prevailing in the country", said Dr Shoibal Mukherjee, an experienced clinical research professional who was also the founding member of ISCR.
A clinical trial patient who was present at the event, shared her experiences. "My participation in the clinical trials helped me get health reports constantly. Despite initial apprehensions, I was cared for and there were no issues at all. At least I got an opportunity to have a treatment than nothing at all," shared the patient on the basis of anonymity.
The patient who was well-educated also laid stress on the need for more volunteers for the trials as it is the only way to test the drugs for disease for which there is no treatment. "Somebody has to come forward to take up the challenge, inspite of the fact that there could be adverse reactions. Otherwise how will new drugs come?," asked the patient.
The experts agreed that over the last one and half years, the regulators have introduced several new orders and guidelines to strengthen the regulatory environment for the conduct of clinical research in India. While these is a positive movement forward in ensuring better governance of clinical research and protecting the rights and safety of patients, some of the new rules like the compensation guidelines, mandatory audio-visual recording of informed consent, limiting the number of trials for investigators, have been knee jerk reactions to external environmental pressures and go against the basic principles of research as also patient interest.
Clinical research stakeholders continue to face challenges with various aspects of the regulatory reform: