Abstract
Clinical trial regulations should remove unnecessary obstacles for the conduct of pragmatic trials assessing the comparative effectiveness of medicines posing no or minimal risk to participants, say Rafael Dal-Ré and colleagues
Original language | English |
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Article number | 1092 |
Number of pages | 8 |
Journal | BMJ |
Volume | 364 |
DOIs | |
Publication status | Published - 27 Mar 2019 |
Bibliographical note
AcknowledgmentsWe thank Cristina Gómez Piqueras (general subdirectorate of data inspection, Spanish Data Protection Agency) and Alessandro Spina (data protection officer, European Medicines Agency) for their comments on our interpretation of the provisions of the GDPR regarding participants’ informed consent in medical research, and Jan P Vandenbroucke (Leiden University) for his advice. We also thank A de longh, N Ivers, M, Zwarenstein, and The BMJ editors for their comments and suggestions.
Keywords
- CLINICAL-TRIALS