Clinical Trial MonitoringEthics in Clinical Research

Clinical Trials in India! Blessing or Curse?

Hi All! This is Phani Kumar and I work with Clinexa Life Sciences as a Clinical Research Associate. I recently came across an article in a magazine that talked about Indians being used as guinea pigs in clinical trials and would like to put forth my views on this issue.
Clinical research can simply be defined in lay man terms as any experiment conducted on human beings to evaluate the safety & efficacy of new drugs, medical devices, new drug delivery systems etc. India has become a hub for conducting clinical trials because of its vast Geo and Bio diversity, low trial cost, faster recruitment rate, highly qualified English speaking professional medical community and availability of a large number of patient population. In this modern world, every individual runs toward a superior element than the existing inferior one. Big Pharma companies are discovering several hundreds of new molecules every year which has resulted in the availability of better, more efficacious and safer drugs in the market today! This, my dear friends is not possible unless the drugs are tested in humans at some point of time. Human body is unique and no animal or computer generated model can accurately predict the effect of the drug in humans. Thus, we cannot escape the fact that new drugs have to be tested in humans, come what may…

Many people in India consider clinical research as a curse to the Indian society. Some magazines support this in India and state that “Human Beings are treated as Guinea Pigs”. This according to me is because of lack of appropriate knowledge about clinical research and may be because of some not so good incidents that may have happened in the past. The fact is that the Clinical Trial Regulatory Approval Process has streamlined in India since 2005 and there have been recent efforts by the government of India to improve ethical practices which has also played a critical role in positioning India as a leader in global clinical trials. While I do understand the concern of people who are opposed to the concept of clinical trials in India regarding the protection of rights and safety of the Indian population, but they should understand that there are checks and measures, and guidelines and regulations to be followed at every stage of a clinical trial to ensure that the rights safety and well being of study subjects is being protected at all times.
One simple and the most basic example of this is the conduct of the informed consent process before a patient is enrolled in a clinical trial. In this process, the eligible patient is informed about all aspects including risks and benefits of a proposed clinical trial by the concerned doctor (Investigator) and is provided sufficient time to think about it and to decide whether or not he or she should participate in the trial.
Another example of how safety of subjects is protected is by having an ethics committee in place. An ethics committee which is comprised of a number of people ranging from physicians, non scientific, legal and lay persons, has to approve the conduct of the study and the informed consent forms being used for the informed consent process at a particular study site.
Also, throughout the study the ethical conduct of the study is verified by the sponsors representative who visit the study site at regular intervals to check the study conduct, verify adherence to guidelines and regulations, and study specific procedures.
Thus, in my view, people especially the media, must not out-rightly close their eyes to clinical research and must not create a negative feeling about this topic. They must not forget that meaningful work is being done by most companies involved in clinical research, which is bound to make peoples lives, the Indian peoples lives, better in times to come. We are all humans and mistakes do occur, but that does not mean we should generalize the same and consider it as a routine in this industry.

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