Norms For Drug Trials On Humans Announced

The government today released a set of guidelines on good clinical practices that prescribe standards for drug trials on humans.

The GCP, formulated by an expert committee set up by Central Drugs Standard Control Organisation in consultation with clinical experts, will ensure uniform quality of clinical research throughout the country and generate data for registration for new drugs before their use. GCP will provide a standard for clinical studies or trials that encompass the design, conduct, monitoring, termination, audit, analyses, reporting and documentation of the studies.

They will ensure that the studies are implemented and reported in such a manner that there is public assurance that the data are credible, accurate and that the rights, integrity and confidentiality of the subject are protected, the guidelines say.