requiring all clinical trials to register at www.clinicaltrials.gov or an appropriate trial registry at the onset of patient enrollment to be considered for publication (DeAngelis et al., 2004, 2005; Laine et al., 2007). The ICMJE defined a clinical trial broadly to include “any research project that prospectively assigns human subjects to intervention and comparison groups to study the cause-and-effect relationship between a medical intervention and health outcome” (DeAngelis et al., 2004, p. 2436). This policy led to a 73 percent increase in trial registrations at www.clinicaltrials.gov for all intervention types (Zarin, 2005). More recently, every protocol registered at www.clinicaltrials.gov is required to undergo an automated review to identify missing information and a quality review to assess whether the experiment is presented accurately (Zarin et al., 2011). These practices are likely to improve the quality of the entries.
However, despite the recent increase in trial registration, not all trials are registered at www.clinicaltrials.gov, and many journals still publish studies that have not been posted in the database. Those entries that are posted often still lack essential information about the trial. Also, some trials fail to register prior to patient enrollment, as required by law and the ICMJE policy (Meldrum and DeCherney, 2011; Zarin et al., 2011). Although FDA is trying to encourage sponsors to present more information on the website, “the usefulness of www.clinicaltrials.gov ultimately depends on whether responsible investigators and sponsors make diligent efforts to submit complete, timely, accurate, and informative data about their studies” (Zarin et al., 2011, p. 860). Journal policies are one mechanism to encourage comprehensive trial registration, including trials of omics studies. Thus, the committee recommends that journal editors require authors who submit manuscripts describing clinical evaluations of omics-based tests to register all clinical trials at www.clinicaltrials.gov or another clinical trial registry acceptable to the journal (Recommendation 7[a][i]). The peer review process should confirm that authors have registered their trials and that any data posted in the registry is consistent with the data submitted for publication (Meldrum and DeCherney, 2011).
Data and Code Availability
Baggerly and Coombes, two statisticians from MD Anderson who wanted to reproduce the omics-based tests being used in clinical trials at Duke University, reported spending more than 1,500 person-hours trying without success to replicate the statistical analyses. If all the data used to develop the omics-based tests had been transparent and publicly available, checking the validity of the results would have been much faster and easier. To facilitate the reproducibility of omics research, Baggerly and Coombes recommended that journals require authors to make the following five items