What are clinical trials?
An introduction to clinical trials
Clinical trials are an essential part of the medical development process and involve moving medicines and therapies out of the laboratory for eventual use with patients. Before any new medicine or treatment can be prescribed by a physician, and hence be made available to the general public, it must be proven that it is:
- Safe
- Effective
- Better than any existing medicine or treatment
Only if these characteristics of the medicine are proven, will it receive approval from the authorities regulating the pharmaceutical industry. In order to receive this approval, a certain number of steps must be undertaken, where the safety and efficacy of the medicine or treatment are established in tests.
These steps are broadly termed clinical research trials (clinical trials) and include distinct phases to see how people react to a medicine or treatment. A carefully monitored clinical trial is by far the best way to establish if a new treatment is safe, effective, and better than what is already available. During testing, the safety of the participants is given the highest priority. This focus on safety is rigorously enforced by a number of government authorities, which include:
- Medicine and Healthcare Regulatory Authority (MHRA)
- National Research Ethics Service (NRES) of the National Patient Safety Agency
- European Medicines Agency (EMEA)
Finally, every physician directly involved with clinical trials has undergone extensive training and must adhere to safety checks and submit to monitoring and reviews.
Clinical trials are an essential part of developing new medicines and can only be performed with the help of study volunteers. By volunteering for a clinical trial you can help the medical research process, aiding in the development of a new treatment, an improved medicine or possibly a cure.
More information can be found in the Medical Research Council's excellent leaflet Clinical research: It's everyone's business, which summarizes the vital role of clinical trials.
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