Characteristics and publication fate of unregistered and retrospectively registered clinical trials submitted toThe BMJover 4 years

Abstract

ObjectivesWe sought to evaluate the characteristics and publication fate of improperly registered clinical trials submitted to a medical journal (The BMJ) over a 4-year period to identify common types of registration issues and their relation to publication outcomes.DesignResearch articles submitted to The BMJ and identified as unregistered or retrospectively registered by editors were included if they reported outcomes of a clinical trial. Relevant data regarding the trials were then extracted from each paper. Trials were categorised as prospectively registered, registered in an unapproved registry, unregistered or other, and explanations for registration deficiencies were grouped into six categories. We searched PubMed and Google to determine whether, where and when improperly registered studies were subsequently published and whether registration issues were disclosed.Results123 research papers reporting apparently unregistered or retrospectively registered clinical trials were identified. 110 studies (89.4%) were retrospectively registered, nine (7.3%) were unregistered, three (2.4%) had been registered in an unapproved registry and one study originally lacking registration details was later discovered to have been prospectively registered. 82 studies (66.6%) were funded entirely or in part by government sources, and only seven studies (5.7%) received funding from industry. Of those papers submitted to The BMJ through the end of 2015, 67 of the 70 papers rejected for registration problems (95.7%) were subsequently published in another journal. The registration problem was disclosed in only 2 (2.9%).ConclusionsImproper registration remains a problem, particularly for clinical trials that are government or foundation-funded. Nonetheless, improperly registered trials are almost always published, suggesting that medical journal editors may not actively enforce registration requirements.

Registration of published randomized trials: a systematic review and meta-analysis

“…Another reason for the difference is that we included trials registered in other registries and that practices with regard to prospective registration might be different among trials registered in these. Lastly, among 123 trials rejected by the BMJ between June 2013 and June 2017 because they did not comply with ICMJE trial registration requirements, 89% were retrospectively registered and 7% were unregistered [ 83 ].…”

A systematic review of clinical trial registration in major respiratory journals 2010–2018

“…Previous studies have suggested that although ICMJE guidance recommends that journals should not publish manuscripts from trials that were not registered or were retrospectively registered, such trials continue to be published in the medical literature, including in high-impact journals. 4 While compliance with ICMJE registration has been investigated in individual specialities such as cardiology 5,6 , no studies to date have reported on adherence to the ICMJE policy within respiratory medicine.…”

“…Classification of trials followed a published approach used by the British Medical Journal. 4 Briefly, a trial was considered to be registered if the publication included a registration number of an acceptable primary registry -one belonging to the WHO International Clinical Trials Registry Platform (ICTRP). If no registration number was reported in the publication, the trial was searched for using the ICTRP search platform.…”

SMOOTH: Self-Management of Open Online Trials in Health analysis found improvements were needed for reporting methods of internet-based trials

“…Clinicaltrials.gov originally encouraged registration for trials that dealt with serious illness. This position was expanded when The International Committee of Medical Journal Editors (ICMJE) announced in 2005 that their journals would no longer publish reports of trials unless they were prospectively registered in a trial registry that met the quality standards recommended by the World Health Organization (73). The risk of selective reporting remains a threat in 2017 where approximately one third of trials listed in ClinicalTrials.gov were registered three months following participant enrollment and of these, fifty percent were not registered within the first 12 months (74).…”