Clinical research begins when a product or theoretical regimen is conceived in the laboratory. The process will then proceed through four phases, following strict guidelines of experimentation and documentation set by science and research communities. Promising results in clinical studies will prompt more testing, before the product, device or regimen can be brought before a regulatory body for review as an investigational drug or device. The test article, whether it is intended for diagnosis, prevention or treatment of a particular condition, cannot be used on human subjects in any way, prior to regulatory approval. In the clinical trials that involve humans, healthy volunteers are recruited to participate in closely monitored and rigorously documented studies.
The Food and Drug Administration acts as the central regulatory body in the United States for clinical trials. In Europe, the European Medicines Agency monitors medical research performed within its borders. These are by no means the only organizations involved in vetting a drug or device intended for human use. The Research Ethics Board, Radiation Safety Committee, the Privacy Board and other groups will be engaged in the process to ensure that all aspects beyond medical considerations will be addressed sufficiently to protect public interest.
Medical investigations require a substantial investment in time, money, human and capital resources. It is estimated that medical research spending reached $100 billion in the last decade. About 60 percent of these funds come from pharmaceutical sources as well as related industries.
The discussions found in http://www.clinicalresearch.in will endeavor to monitor and explain research trends and findings so that consumers can have access to these important information.