Improving transparency in registration of randomized clinical trials in critical care

Excerpt

Registration of randomized clinical trials (RCTs) in easily accessible electronic databases was broadly promoted at the turn of the century as a means of promoting the transparency and validity of human subjects research. Currently, 17 different web-based databases are available for this purpose, sponsored by national or international initiatives such as clinicaltrials.​gov (USA), REBEC (http://​www.​ensaiosclinicos.​gov.​br, Brazil), and ISRCTN.​org (international). With prospective registration of all RCTs, key stakeholders would have the ability to access details of any contemporary trial. Systematic reviews and meta-analyses of these trials would become more valid, because the potential for publication bias (inclusion of only those trials that get published, which often differ systematically from those that do not) would at least be clarified and possibly mitigated. Finally, prospective disclosure of other key details of RCTs, such as the sample size targeted and the trial’s primary outcome, might combat the myriad temptations that arise during the arduous conduct of RCTs to alter these and other key design features in light of lessons learned. …