Clinical trials: A ray of hope thwarted by norms

Experts suggest amendments to present regulations

Rahul (name changed) has been a patient of Haemophilia since his childhood. He lived a life of worry needing blood transfusions every eight hours.


Until the day when his doctor told him of a clinical trial for a new drug to battle Haemophilia. He fulfilled all the patient criteria necessary to enrol for the trial. With his doctor’s advise he soon became a hopeful and successful volunteer for the trial.

However, not every patient suffering from life-threatening diseases gets this chance for hope and survival as Rahul did. Carrying out research and experimental procedures in the country has become increasingly difficult owing to the new regulations for such trials enforced in 2013.

A discussion weighing the pros and cons of these regulations was held by the Indian Society of Clinical Research (ISCR) at the Rotary Club on Wednesday. The influence of the regulations on medical research, trials and patients was discussed.

Participating in the discussion, Suneela Thatte, president of the ISCR, said that 16 per cent of the global population lives in India and the country contributes to 20 per cent of the global disease burden and yet, when it comes to clinical trails for development of new drugs, only about 2 per cent of the global clinical research and trials take place here. She termed the stringent regulations governing medical research as a major obstacle hindering researchers, a­c­­­a­de­micians and sponsors.

There are patients who are willing to see hope in an experimental breakthrough. Research is capable of giving them a possibility for cure, while many trials could help them manage the disease to live longer.

Dr P P Bapsy, senior oncologist at a corporate hospital and who has worked at Kidwai Institute for almost three decades, referred to some of the norms for a patient’s voluntary enrolment that discourage trials. She said that the patient’s consent for the trial has to be an audio-visual recording. A heavy compensation is demanded, even if an enrolled patient dies of injuries or maladies completely outside the purview of the trial.

She said that many patients suffering from cancer are taking part in trials outside the country, in Korea, Japan and Singapore where research and trials are conducted simply because they give the patient hope to survive and live a little longer.

The ISCR members suggested the government to make amendments to the present regulations to benefit patients, to strengthen the ethics committee to take a decision regarding the compensation and to make the process of approving a clinical research time bound.

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