CommentPublic availability of trial protocols
References (3)
- et al.
SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials
BMJ
(2013)
Cited by (11)
A meta-research study of randomized controlled trials found infrequent and delayed availability of protocols
2022, Journal of Clinical EpidemiologyCitation Excerpt :Although the benefits of making protocols publicly available are well established, data quantifying their availability and the timing of their availability are limited to three studies [6,24,25]. Sender et al. [6] primarily focused on nonpharmacologic trials, Lucey et al. [24] only included RCTs that were submitted to the Lancet, and Spence et al. [25] only included RCTs whose results were only published in high-impact journals [25]. Overall, there is limited generalizability concerning these findings [6,24].
Substantial delays in clinical data published by the European Medicines Agency – a cross sectional study
2022, Journal of Clinical EpidemiologyCitation Excerpt :Additionally, trial registries may contain outcome data from completed trials. However, the information about the results available in registries is insufficient just as is the case for published reports when evaluating clinical trials [4,5], and study protocols are often not publicly available [6]. The most complete reports of the planning, conduct and results of randomized trials of drugs are the full, unabridged Clinical Study Reports (CSRs) compiled by pharmaceutical companies as part of their application for marketing approval with drug regulatory agencies [7,8].
Analysis of articles directly related to randomized trials finds poor protocol availability and inconsistent linking of articles
2020, Journal of Clinical EpidemiologyCitation Excerpt :Author response rate to email contact was approximately one-third of those contacted, which is similar to other studies [12,15]; however, in these studies, corresponding authors of all articles were contacted. The availability of protocols does not seem to be improving over time, with an analysis of trials submitted to The Lancet in 2016 finding that only 95 (36%) of the 216 submissions had a protocol that was publicly available [16]. Our study specifically looked at the accessibility of a trial protocol; this is important, as there is evidence to suggest that selective reporting of outcomes occurs in randomized trials [17,18], and this can be detected by comparing protocols to the main published trial report.
The clinical trial transparency in oncology significantly increased over the recent years
2020, Journal of Clinical EpidemiologyCitation Excerpt :Non–industry-funded studies were less likely to be prospectively registered but more likely to provide protocols than were those solely funded by industry sources. Similar findings were reported among manuscript submissions to The Lancet [16]. This phenomenon may be due to the proprietary nature of products and the desire of pharmaceutical companies to keep protocols confidential to protect intellectual and commercial interests [8].
SPIRIT promotes protocol sharing
2018, The Lancet Psychiatry