The unintended consequences of clinical trials regulations.
editorial · Level V
Where this comes from
- Record sourced from PubMed, PMID 19918557.
- Also identified by DOI 10.1371/journal.pmed.1000131 and PMC identifier 2768793.
- Licence recorded as CC BY.
- The licence permits redistribution, so the abstract is shown in full and the full text is available from the publisher.
Abstract
Alex McMahon and colleagues critique the International Conference on Harmonisation (ICH) guidance on good clinical practice (GCP), arguing that it is having a disastrous effect on noncommerical randomized clinical trials in Europe.
Medical subject headings
- Clinical Trials as Topic
- Evidence-Based Medicine
- Government Regulation
- Practice Guidelines as Topic