Adaptation of the Application of Good Clinical Practice Depending on the Features of Specific Research Projects

Abstract

-The conduct of clinical trials falls within a strict regulatory framework. The objective of the round table was to develop reasonable recommendations for the implementation of GCP according to the type of research and taking in account the risks and challenges related to this research. Two types of risks have been identified: those related to the characteristics of the research and those related to the impact of the study results. The group designed an evaluation table of these risks. The round table focused its investigations on 3 main themes: monitoring, the investigational medicinal product and undesirable effects.

Risk analysis and risk adapted on-site monitoring in noncommercial clinical trials

“…Though the idea of risk assessment in the context of clinical trial monitoring has been presented before [1][2][3]11], to our knowledge, no comprehensive procedure for risk analysis has been published so far. The Clinical Trial Risk Assessment proposed by the Medical Research Council, accessible online as a draft version [2], provides a list of hazards for the participants' rights and safety and for the reliability of the trial.…”

“…In particular, there is no guidance for sponsors or sponsor-investigators on how to proceed with the risk analysis, and on the extent of monitoring required. The risk assessment practiced by the AP-HP [3] for several years now is based on a formal score, which covers only aspects concerning the phase of the trial and the study population, and particularly lacks aspects affecting the reliability of trial results. In contrast to the AP-HP proposal, the structured procedure for risk assessment proposed in this article is not intended to support a formal external risk classification.…”

“…(1) Extensive literature research (MEDLINE, further pertinent journals, web sites of funding organisations, research networks, study groups), with the purpose to identify proposals for monitoring strategies and other QM measures as well as their impact on data quality and patient safety. The research revealed a lack of references on this topic, only two approaches for risk assessment were identified [2,3]. Relevant literature on QM measures in clinical trials was summarised in a systematic review [4].…”

Framework conditions facilitating paediatric clinical research

“…Clinical trial monitoring according to a risk-based approach would be more appropriate for off-patent products. It would entail a substantial reduction of workload and cost, particularly for academic institutions that run low-risk studies using marketed drugs [ 5 , 34 ]. To define the legal risk of a clinical trial, insurance companies have a more quantitative and simplified approach of the risk/benefit assessment than scientists.…”