Wednesday, 18 April 2012

Research and Clinical Trials

Clinical Trials for medications and drugs 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. It is possible that the full benefits of the study medication may never be seen in the patients enrolled on the study, bur future generations would benefit from the same.

All trials are governed via Ethics Committees, which may be locally 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"

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