Clinical research is as an experiment conducted on human beings to evaluate the safety & efficacy of new drugs, medical devices, new drug delivery systems etc. Several thousands of new drugs enter the market each year and unless they are tested in humans, we cannot accurately predict their effect on them. Thus, clinical trials become necessary.
But, many people in India consider preclinical research as a curse and state that “Human Beings are treated as Guinea Pigs.” They are concerned about the protection of rights and safety of the Indian population, but there are checks, measures, and guidelines and regulations for every stage of a clinical trial. This ensures that the rights, safety and well being of the study subjects are protected at all times.
Here are the few examples of these guidelines and regulations:
- Informed consent – consent is obtained from the eligible patient before conducting any experiment. He is informed about all the risks and benefits of the proposed clinical trial by the concerned doctor and sufficient time is given to think and take his decision.
- Ethics committee – comprising of physicians, non scientific, legal and lay persons, has to approve the conduct of the study and the informed consent forms.
- The study sponsors – visit the site regularly to check and verify adherence to various guidelines.
Clinical trials are necessary to make human lives better in the near future and we must not create a negative feeling about it.
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