Putting patients first

This year, on International Clinical Trials day, India has a reason to feel satisfied with the progress made in regulating the use of humans to test drugs. In August last year, the Supreme Court had batted for patient safety, coming down hard on the clinical research industry. But this is just the beginning. A vibrant environment needs to be created wherein adequate safeguards are available for trial patients while promoting novel research.

Though instances of unethical conduct of clinical trials in India dated back to 2005, the issue came under spotlight only in June 2011, after the Economic Offence Wing of Madhya Pradesh submitted its enquiry report. The report brought to light some gruesome facts about the conduct of trials in the state. Thousands of individuals, mostly children, were subjected to drugs and vaccines trials between 2006 and 2010, violating guidelines.

Even the mentally ill were not spared. Many such patients were subjected to trials for various drugs including the ones used to treat premature ejaculation. This was driven by perverse, profiteering motive pursued by a few clinical research organisations (CROs) that amassed millions of dollars at the expense of innocent patients. “The entire research community has been blamed for the mistakes of isolated people,” says Suneela Thatte, President of Indian Society of Clinical Research (ISCR).

After series of unsuccessful debates in various forums including the Vidhan Sabha, a writ petition was filed in the Supreme Court in January 2012 by the NGO Swasthya Adhikar Manch and others. In October 2013, the court ordered halting of all the 157 clinical trials approved between January and August 2013. It sought a detailed report from the apex and technical committees, assessing the risk versus benefit for patients, before allowing trials in these 157drugs. The court also expressed concern over the non-existence of a strong framework to ensure safety of these patients.

This is a very positive move. Some changes have since been effected to the existing regulations such as mandating a video recording of the patient consent, registration of ethical committees and formulation of compensation for trial subjects who suffer adverse reaction, to name a few. But this will not suffice. Ensuring effective implementation of the set regulations is the most critical aspect.

Ensuring strict adherence to regulations will not only ensure protection of patients’ right but will also benefit the CROs who have been doing legitimate business. “We have always wanted robust regulatory framework governing clinical trials in India,” agrees Thatte.

The SC order is conducive to patients, but it has also made the clinical trial industry aware of its responsibilities towards patients. Today, on the occasion of International clinical trials day, the industry body ISCR plans to distribute a special patient handbook, which will serve as a guide for those who intend to participate in clinical trials. It is also conducting patient awareness programmes.

The industry’s efforts now seem to be directed towards re-building the confidence among the patient community, while also sending the signal to the government that they are willing to adopt the best practises in clinical trials.

As a developing country, India needs to encourage investment in innovative research. Hence, it is important to strike a balance between safety of trial subjects and the country’s healthcare needs, without compromising one for the other. “Patient is a very important stakeholder. Unless they come out and participate in trials, no innovative medicine will be available to patients” adds Thatte.