Quality requirements in clinical studies: a necessary burden?

Abstract

Drug development has continued to progress over the past decades and the processes involved have become more complex. The basis for these changes include advances in substance analysis and production, targeted drug development and defined guidelines for the conduct of clinical trials. The aim of standardised quality requirements is to generate scientifically sound data in clinical trials while observing strict ethical rules. The conduct of clinical trials is governed by internationally established Good Clinical Practice (GCP) guidelines. For the protection of human beings directly involved, framework conditions must be established as guidelines to accompany the research process. At the same time, these regulatory requirements enable a quality criteria standard to be defined. However, those regulations form a major challenge for clinical study centres, since they affect current clinical practice considerably. The objective of this paper is, on the one hand, to clarify the historical background relating to the development of clinical trials and the corresponding legal guidelines, on the other hand, to discuss consequences for clinical practice.