Clinical Trials: What is it?

Explore what are clinical trials work and its significance in medicine.

The development of new medicines and medical practices is at the forefront of medical research, with researchers endeavouring to find the best thing or way to manage or treat various conditions and diseases. Clinical trials are at the core of this process, especially when humans are the designated recipients of such innovation. These trials ensure that any medicine, surgical method, or, more broadly, an intervention is safe, well-tolerated, and efficacious.

Simply speaking, in a clinical trial, investigators enrol participants who meet certain qualifying criteria, then administer the intervention being tested, and finally measure the outcomes – all according to a predetermined plan.

Trials can test drugs, medical devices, and even procedures. They may compare a course of treatment to existing regimens or a placebo; they may be blinded or double-blinded; in fact, there are several types of clinical trials depending on the investigators’ needs.

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Ultimately, a trial’s results should help investigators determine the safety and efficacy of the intervention to a reasonably high degree of confidence.

Clinical trials also have phases. Vaccines developed against SARS-CoV-2 had to go through four. (Because vaccines are given to healthy people, they need to be tested more than drugs that are given to people who are ill.) Each phase was based on the trial’s objective, number of participants, and some other characteristics.

In India, the Indian Council of Medical Research maintains an online public-record system called the Clinical Trials Registry-India. All clinical trials in India are required to register themselves here.