Experiences with GCP in the pharmaceutical industry [corrected]

Abstract

The Declaration of Helsinki and the "new" Germany Drug Law of 1976 may be regarded as the first and all important step in the evolution of Good Clinical Practices (GCP) in Germany. "Regulations on the orderly conduct of clinical studies" (published in 1987), reflecting most elements of the GCPs, caused the German industry to make provisions for more successful drug approvals in the future. Pharmaceutical companies have improved their documentation systems with regard to study protocols and reports, increased their monitoring capacity, and began setting up SOPs. In preparation for the issuing of the E.C. GCP guidelines companies established Clinical Quality Assurance (CQA) units responsible for various CQA tasks such as training of monitors and investigators, auditing of protocols, reports, systems, and data. Typical problems connected with the implementation of GCP in Germany appear to be contradictory opinions of the various ethics committees, reluctancy on the part of investigators to assume additional bureaucratic workload, difficulties on the part of the sponsor resulting from the high financial and manpower requirements, as well as the relatively unfavorable political and public opinion of clinical research. The benefits achieved by the introduction of GCP are already visible, i.e., increased quality of study protocol, conduct and report of studies, reduced number of studies, transparency at all stages of clinical research and increased ethical awareness.