Very few journals require or enforce prospective registration of interventions not subject to regulation by the Food and Drug Administration (FDA), which include surgical procedures, nursing interventions, diets, psychological treatments, and rehabilitation techniques, according to a study published in JAMA Internal Medicine. There is a need for developing a universal trial registration policy of unregulated interventions and improving registration practices.
The investigators of this study sought to determine whether journals that specialize in the publication of nonregulated healthcare intervention trials require prospective registration and if their registration policies are associated with the publication of prospectively registered trials, trials with adequately registered outcomes, and trials where primary registered outcomes and published outcomes were consistent.
The investigators searched the PubMed database daily for the publication of nonregulated intervention randomized clinical trials between March 2016 and September 2016. In total, 254 journals were identified, including all journals in the Clarivate Analytics Science Citation Index Expanded categories of behavioral sciences, nursing, nutrition and dietetics, psychology, rehabilitation, and surgery. From these journals, 953 intervention trials not subject to FDA regulation were identified and included in the analysis; data were extracted on journal registration policy, trial registration status, and trial registration and publication characteristics. Journals were classified as requiring prospective registration (with or without a timing requirement), having no prospective registration requirement, or having conditional requirements. A prospective registration was classified as adequate if it had single or multiple primary outcomes with a specific metric and assessment time point.
Of 254 journals, 29 (11.4%) required prospective registration, and 12 (4.7%) had conditional requirements based on the date of trial initiation or journal submission. Of the 953 nonregulated intervention trials, 496 (52.0%) were not registered, 189 (19.8%) were registered prospectively, 141 (14.8%) after initiating participant enrollment and before collecting outcomes, and 120 (12.6%) after completing the trial. A total of 98 (10.3%) trials were published in journals that required prospective registration, and 33 (33.7%) of these were registered prospectively. Comparatively, 156 (18.2%) of 855 trials published by journals without requirements were registered prospectively (P =.004). Only 3 of the 98 trials published in journals with policies had adequately registered outcomes and were consistent with published outcomes vs 34 of 852 trials published in journals without policies (3.1% vs 4.0%; P =.62).
Limitations to the study included a focus on specialty journals and not other types of journals; the investigators did not collect data on the trial registration of drugs, biologics, and medical devices, as these are typically subject to FDA regulation. Furthermore, the investigators did not examine clinical trial registries to see if the included trials reported summary results.
More than half of the trials analyzed were not registered, and regardless of policy, any journal included in this study that published more than one unregulated trial (range 2 to 14) enforced prospective registration less than half the time. The investigators suggest that strategies for the prospective registration of nonregulated trials should be developed and tested, and improved practices surrounding registration should be enforced.
Azar M, Riehm KE, Saadat N, et al. Evaluation of journal registration policies and prospective registration of randomized clinical trials of nonregulated health care interventions [published online March 11, 2019]. JAMA Intern Med. doi: 10. 1001/jamainternmed.2018.8009