What is a Clinical Trial?

Before becoming available as a treatment, drugs and cells that show promise in laboratories must undergo rigorous testing in a clinical trial. A clinical trial is an organized system to test the safety and effectiveness of a proposed treatment. A clinical trial usually consists of a network and several clinical institutions. The network is responsible for the organization, administration, development of protocols, training, and government approvals needed for the trial. The individual institutions evaluate and select the trial participants and conduct the treatments based on previously approved protocols.

A clinical trial consists of three phases:

Phase 1 is to test the safety of the proposed treatment. It includes a limited number of participants who are given the treatment to see if there are any side effects.

Phase 2 is to test the efficacy of, and to optimize, the treatment. Phase 2 trials involve a comparison between groups receiving different treatments and are conducted on with a small number of participants.

Phase 3 is a broader test of the optimized treatment on a larger number of people. It involves the optimized treatment compared with other options and usually is conducted at multiple centers.

Should you participate in a clinical trial?

Volunteering to participate in a clinical trial is not something you do for yourself; it is something you do as service to the community. It isn’t about getting to be first in line for a new treatment. It’s about being willing to weigh risks as well as potential benefits so that potential treatments might be proven to be effective. It is a way to learn so that they might be improved for future trials. It also is a way of finding out that things which might appear promising in laboratories don’t work in people. This also is a valuable lesson as it allows time and resources to be directed into more promising avenues. A negative result also closes down those who charge people with false claims.