How Does Clinical Research Run?
A Bird’s Eye View
Everything starts with an idea. Much before involvement at the level of a family physician, Phase I trials are undertaken to determine basic safety, dosage and proof of concept. These are usually small trials. If things go well, the concept moves on to Phase II. In these trials dosages are better defined and safety is again examined. Phase II trials are generally larger and may involve more than one center. If this goes well the concept moves on to Phase III trials. This is generally the level at which we may become involved.
In Phase III clinical trials researchers continue to further check the safety and efficacy of a given product on a larger scale. This often involves multiple clinical research sites (of which we may be one). Phase III trials must pass through several assessments including that of a scientific team, an ethics committee, the Food and Drug Administration (U.S.) and Health Canada.
To a limited extent Phase III clinical trials are a work in progress. Clinical research involves consistent and thorough communication between the researcher and the other teams involved to ensure that what eventually comes to market has the efficacy and safety data to support its use.
Phase IV trials are run post-approval of drugs to ensure safety and efficacy.
For more information please refer to Health Canada’s website.