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[Will good clinical practice domesticate human research?]
T Buclin1, B Burnand, J Biollaz
1Division de pharmacologie et toxicologie cliniques, Hôpital de Beaumont CHUV, Lausanne. thierry.buclin@chuv.ch
Abstract:
During recent years, an increasingly comprehensive set of rules and guidelines has been developed around clinical trials, to ensure their proper ethical, methodological, administrative and financial conduct. While initially limited to new drug development, this regulation is progressively invading all areas of clinical research, with limited respect for the heterogeneity in aims, resources, sponsors and epistemological grounds. No clinical study should be planned without consideration of a series of legal requirements, which are reviewed. Concerns about their practical implications are critically assessed.
Insights
Clinical trial regulations are expanding beyond drug development, impacting diverse research areas. This review assesses legal requirements and their practical implications for study planning.
Area of Science:
- Clinical Research
- Regulatory Science
Context:
- Increasingly comprehensive rules and guidelines govern clinical trials.
- Regulation is expanding from drug development to all areas of clinical research.
- This expansion shows limited respect for research heterogeneity.
Purpose:
- To review legal requirements for clinical study planning.
- To critically assess the practical implications of these regulations.
Summary:
- A growing body of regulations aims to ensure ethical, methodological, administrative, and financial conduct in clinical trials.
- These regulations, initially focused on new drugs, are now broadly applied across clinical research.
- The review examines essential legal considerations for planning any clinical study and evaluates their real-world impact.
Impact:
- Highlights the need for careful consideration of legal requirements in all clinical research planning.
- Raises concerns about the practical applicability of uniform regulations across diverse research contexts.
- Informs researchers and sponsors about the evolving regulatory landscape and its challenges.
