The editors of CMAJ, 10 other journals and MEDLINE recently announced that, starting in 2005, they will publish only clinical trials that were registered at inception.1 Two reasons are offered for this decision: first, the widespread practice of concealing the results of trials with unfavourable results distorts the evidence base, and second, patients volunteering for clinical trials deserve to know that their contribution to improving human health will be available to inform health care decisions, and this knowledge ought to be accessible to everyone. It appears, then, that pharmaceutical companies have an ethical as well as a scientific responsibility to register their clinical trials.
It seems to us that many patients do participate in clinical trials for altruistic reasons; moreover, the consent forms they sign usually appeal, either explicitly or implicitly, to this motivation. If pharmaceutical companies have an ethical responsibility to register the clinical trials for which they seek patients as participants, should not institutional review boards require registration of large clinical trials as a condition of ethical acceptability? Have any institutional review boards taken a position on this subject?
L. John Hoffer Associate Chair Jack Mendelson Chair Research Ethics Committee Jewish General Hospital Montréal, Que.
Reference
- 1.De Angelis C, Drazen JM, Frizelle FA, Haug C, Hoey J, Horton R, et al. Clinical trial registration: a statement from the International Committee of Medical Journal Editors [editorial]. CMAJ 2004;171(6):606-7. [DOI] [PMC free article] [PubMed]