Research and Clinical Trials

Clinical Trials for medications, drugs and devices are broadly divided in four groups or phases:

• Phase 1: Very early type of research. In some types, it would be a “first in human” study
• Phase 2: Studies would have shown the medication to be relatively safe and it is now being tested for efficacy
• Phase 3: The safety and efficacy have been shown to be favourable, and now it is being tested against the present standard of care
• Phase 4: This study is primarily to gain more information about the medication, as it has already been approved for routine use in the market

Enrolling onto clinical trials is a good thing. It gives access to newer molecules or different ways of using older molecules. The full benefits of the study medication may not be seen in patients enrolled on the study, but others would gain.

All trials are governed via a Human Research and Ethics Committees, which may be local or centrally based. They are the guardians of patients and their families, and would not give permission to conduct a study, unless they are convinced about safety.

The first principle remains – “First do no harm”