Re: Clinical trials: what a waste | The BMJ

"Ioannidis’ recent BMJ editorial offers a stark commentary on the parlous state of clinical trial research and touches on a few potential solutions, including clinical trials registration. Clinical trial registration is pivotal to understanding the research landscape, and for ensuring accountability in research. But what do we do when there are protocols in place to ensure public access to information, but the chain of responsibility fails us? Prospective clinical trial registration can limit the risk of non-publication of completed trials and selective outcome reporting. It is therefore mandated by the International Committee of Medical Journal Editors (ICMJE) Uniform Requirements for Manuscripts as a pre-condition for publication (Laine et al., 2007) . For prospective registration to work trialists need to take responsibility for registering trials prior to inception, maintaining their registry entries as changes to the trial protocol are made, and ensuring that the contacts listed in their registry applications are available and responsive. However, the chain of accountability cannot end with the trialist; journal editors must play their part by ensuring compliance with the ICMJE registration mandate. Increasingly, trial registries allow retrospective registration of trials. This shift in practice means that reporting registry identification numbers no longer provides journals with sufficient proof that a trial is registered in accordance with the ICMJE mandates (i.e., prospectively). As such, the onus to confirm that registration timing aligns with the mandate falls on journal editors. A pilot study conducted at the South African Cochrane Centre, which hosts the Pan African Clinical Trials Registry (www.pactr.org), examined 68 RCTs published in the New England Journal of Medicine (30); Journal of the American Medical Association (8); PlosMed (5); Annals of Internal Medicine (6); and The Lancet (19) between October and December 2011. For three RCTs no trial registry information was available;of the remaining 65 trials, twenty-nine (45%) RCTs were registered prospectively. Of the 36 retrospectively registered RCTs , 21 registered after 1 July 2005 (the ICMJE amnesty deadline for prospective registration), and were therefore published in conflict with the ICMJE mandate. None of the journals reported that these trials were registered retrospectively. In addition, fourteen of 65 (21.6%) RCTs had a discrepancy in reported primary outcomes between published paper and registry. Of those, seven trials were retrospectively registered, three of which started after the 2005 cut-off for mandatory registration ..."