Abstract:

The development of new drugs and medical devices takes many years and a lot of scientific research. After identifying a new molecule, which is likely to be beneficial in human disease, it must undergo rigorous trials to ensure its efficacy and safety. Regulatory bodies ensure that clinical trials are carried out in a uniformly acceptable manner, and that the results are reliable. Their main aim is to protect the individual from harm. The aim of this review article is to describe the process of drug development and clinical trials as well as the role(s) of the regulatory agencies involved. A MEDLINE search was conducted using relevant keywords to access published information on clinical trials. Other sources of information include relevant websites and publications of regulatory agencies and major textbooks. The development of a new drug or device starts from identification of the molecule in the laboratory, where it is postulated to have useful characteristics. Following rigorous animal tests, the drug is then entered into clinical trials using human subjects. Clinical trials are conducted in four phases. Regulatory agencies are involved at every stage to ensure compliance with guidelines. There are various designs of clinical trials that may be used and the appropriate design has to be chosen to produce reliable results. The appropriate statistics must also be chosen and the submission to regulatory bodies for approval must be done in a systematic and scientific manner. The International Conference on Harmonisation was convened in 1990 and has drafted good clinical practice (GCP) guidelines for clinical trials. Submission of the application for a new drug involves proper regulatory writing procedures and protocols.

Keywords: clinical trial, regulatory agencies, ICH

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