Out of 2,36,329 clinical studies being done globally, only 3,016 studies are being done in India. It is much behind countries like the US, Europe, Japan, China, Malayasia and Taiwan and ranks 5th in Asia. South Asia contributes 3,642 studies, Afghanistan contributes 18, Bangladesh 248 with 2 in Bhutan, 71 in Nepal, 348 in Pakistan and 51 in Sri Lanka.
Even as more rational guidelines in 2015 were poised to strengthen clinical research in India, out of the 107 clinical studies reviewed and approved to be conducted in the country, 43 were global clinical trials till the period ending August 2015. This is much below as compared to the year 2014 where 150 clinical studies were reviewed and approved out of which 87 were global clinical trials.
This is however contrary to the fact that the government is considering to rationalise and has revised certain guidelines related to providing ancillary care to the clinical trial participant to giving no fault compensation for any serious adverse event during the clinical trial. Among other such issues which have been streamlined were related to capping the number of studies an investigator can undertake and also number of beds a hospital need to have for conducting the trial.
In the year 2013, just 17 Global Clinical Trials (GCT) were approved to be conducted in India due to hard-hitting revisions in compensation guidelines in January, 2013 which negatively impacted the growth of clinical research in India.
A clinical study involves research using human volunteers also called participants that is intended to add to medical knowledge. There are two main types of clinical studies called interventional studies and observational studies.
India is lagging behind smaller countries like Korea, Taiwan and Japan due to regulations framed following a public interest litigation (PIL) in the Supreme Court a couple of years ago. The regulations were enforced based on the recommendations of the professor Ranjit Roy Choudhury expert committee appointed by the ministry of health and family welfare.
In a clinical trial, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or changes to participants’ behavior, such as diet. Clinical trials may compare a new medical approach to a standard one that is already available, to a placebo that contains no active ingredients, or to no intervention.
Some people who are not eligible to participate in a clinical trial may be able to get experimental drugs or devices outside of a clinical trial through expanded access.
In an observational study, investigators assess health outcomes in groups of participants according to a research plan or protocol. Participants may receive interventions which can include medical products such as drugs or devices or procedures as part of their routine medical care, but participants are not assigned to specific interventions by the investigator as in a clinical trial. For example, investigators may observe a group of older adults to learn more about the effects of different lifestyles on cardiac health.
Although home to a sixth of the world’s population, less than 1.4 per cent of global clinical trials is done in India, a country which also has a fifth of the global disease burden.