OPINION

The heroes of drug development

Each year, May 20 is celebrated as International Clinical Trials Day to mark the day when the world’s first controlled clinical trial was conducted. This year, the Indian Society for Clinical Research (ISCR) has retained its theme of ‘Patients First’ for International Clinical Trials Day 2017. The theme acknowledges the selfless contribution of clinical trial patients in bringing new drugs and new treatment to the market and is also a dedication to patients who are still waiting in hope of a better quality of life made possible through new treatment. No drug that we consume today would have been possible without a clinical trial and patients who participated in them, and it is imperative that we acknowledge the invaluable role these patients have played for over 200 years.

Misconceptions

Unfortunately, while there has been a positive shift in people’s attitudes and perceptions about clinical trials, there is still some unsubstantiated negativism and misconceptions related to them. It is a misnomer that many patients die in clinical trials. Much of the data reported on adverse events in a clinical trial does not make a clear distinction between the death of a patient in a clinical trial and the death of a patient due to a clinical trial. The death of a patient in a clinical trial could be because of a natural progression of the disease he or she is suffering from, a new illness he or she may develop, age-related disorders, or a complication totally unrelated such as an accident. All deaths occurring during a clinical trial, whether related or not to the clinical trial, are reported to the regulatory authorities and are thoroughly analysed by a government-appointed medical expert committee. For clinical trial-related injuries/deaths, regulations mandate providing free medical management for such injury and compensation to the patient/relative as per the defined formula.

It must also be highlighted that contrary to common perception, there is no money to be made in clinical trials. In Phase II-IV studies, participants are reimbursed for expenses incurred in participating in a trial and provided free medical care and treatment but the Indian Good Clinical Practice Guidelines clearly state that payments should not be so large or the medical services so extensive so as to act as an inducement for a patient to take part in a study against their better judgement.

Guidelines on safety

Patient safety is of utmost importance in any clinical trial and efforts have been on over the past few years to make the guidelines more stringent so that patient safety, rights and well-being are protected. For instance, the Informed Consent Process is now required to be recorded on video. There are clear guidelines and processes for reporting adverse events as also for determining compensation which was much needed as there was a lot of ambiguity around compensation.

India has 17% of the world’s population, 20% of the global disease burden and, yet, less than 1.4% of global trials take place in India. If anything we need more clinical trials in India to develop drugs for the huge unmet medical needs of our Indian patients…so we can bring the focus back to patients for whom they matter most.

Chirag Trivedi is President of The Indian Society for Clinical Research

It must be highlighted that contrary to common perception, there is no money to be made in clinical trials.

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