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Electronic letters published:
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Transparency in the informed consent process
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Hasan Yazici, MD Istanbul University, Cerrahpasa Medical Faculty, Istanbul, Turkey, Yusuf Yazici, MD, NYU Hospital for Joint Diseases, New York
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hyazici{at}attglobal.net Hasan Yazici, et al.
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Dear Editor, We read with interest the opposing views of Drs. Mueller et al and Goodman (1, 2) about ending randomized control trials (RCT) “before term”. We suggest there is yet another issue about terminating RCTs early, not discussed by either of our colleagues. We propose the information about what the patient will exactly know or knew about trial duration at the time he/she signed the related informed consent at the very start should be transparent to the reviewers of grants, journal submissions, to the readers if the trial report is accepted for publication and, in fact, to the general public. Such transparency, we reason, not only is simply fair to the trial patient, both seeking remedy and helping science as he/she enters a drug trial, but also is an essential starting point whenever we decide to discuss the related ethical and practical issues of a RCT in the optimal way. The transparency we propose also is also desirable when the issue is not early termination but, just the reverse, undue prolongation of RCTs. The interested reader might find the related debate (3, 4) about one such RCT explanatory. This was where we had brought up the point that we as readers, were not optimally informed about the actual intended duration of the RCT in question when it commenced and we had concerns about what the trial patients knew at the beginning and at various time points. It is important here to note that one potential scientific problem in both the extended and the early terminated RCT is an, what some might call an overzealous, attempt of proving one’s hypothesis – that the drug understudy is working - and shying away from the time honored method of good science, falsification (5). We propose a simple solution to these concerns. Clinical trial registration was initiated in 2005 and has been welcome. We now suggest that effective from a certain point in time in the near future, all manuscripts about clinical trials submitted and published, perhaps even all studies needing informed consent, should submit their informed consents to these registries where the peer reviewers, interested readers, in fact interested anybody, can see what the initial informed consent form (or any amendments thereof) related to that trial actually reads. We envisage our proposal, should it find general support, will surely be a further step in the right direction for transparency which we all seek. Hasan Yazici, MD 1 Yusuf Yazici, MD 2 1 Istanbul University Cerrahpasa Medical Faculty, Istanbul, Turkey 2 New York University, Hospital for Joint Diseases, New York, New York, USA Corresponding author: Yusuf Yazici, MD 246 East 20th Street, New York, NY 10003 yusuf.yazici@nyumc.org References: 1- Mueller PS, Montori VM, Bassler D, Koenig BA, Guyatt GH. Ethical issues in stopping randomized trials early because of apparent benefit. Ann Intern Med 2007; 146: 878-81 2- Goodman SN. Stopping at nothing? Some dilemmas of data monitoring in clinical trials. Ann Intern Med 2007; 146: 882-7 3- Yazici Y, Yazici H. Trial of etanercept and methotrexate with radiographic and patient outcomes two-year clinical and radiographic results: Comment on the article by van der Heijde et al. Arthritis Rheum. 2006; 54: 3061-2 4- Van der Heijde D, Klareskog L. Reply to letter by Yazici and Yazici commenting on the two-year report on the trial of etanercept and methotrexate with radiographic and patient outcomes. Arthritis Rheum. 2007.;56:1031-2. 5- Yazici H. Use and Abuse of the Controlled Clinical Trial. Bull NYU Hosp Jt Dis 2007; 65:132-4 Conflict of Interest:None declared |
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