Keeping patients safe while avoiding bias in randomised trials

BMJ 2012; 344 doi: https://doi.org/10.1136/bmj.e3297 (Published 14 May 2012) Cite this as: BMJ 2012;344:e3297
  1. Nick Freemantle, professor of clinical epidemiology and biostatistics1,
  2. Frans Van de Werf, professor and chairman2
  1. 1PRIMENT Clinical Trials Unit, Department of Primary Care and Population Health, UCL Medical School, London NW3 2PF, UK
  2. 2Department of Cardiovascular Medicine, University Hospitals Leuven, Belgium
  1. nicholas.freemantle{at}ucl.ac.uk

Safety monitoring in non-pharmaceutical trials should be stronger

Investigators in randomised clinical trials have a duty to prevent undue hazards for their study patients. To protect patients in trials an independent committee—usually called the data and safety monitoring board, data monitoring and ethics committee, or independent data monitoring committee—is formed to monitor the results as they unfold. To avoid bias, monitoring should be conducted in confidence and the results not communicated to study staff, investigators, or patients. Unfortunately, this does not always happen in device trials and investigator led trials. Further guidance is needed to bring all trials of human subjects up to adequate standards for safety monitoring.

Trials sponsored or run by drug companies are required to follow good clinical practice as described by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH E6).1 In addition, ICH E9 and ICH E6 make specific recommendations on how data safety and monitoring boards should monitor safety during trials to ensure that patients are not placed at undue risk while the internal validity of …

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