Institutional dashboards on clinical trial transparency for University Medical Centers: A case study

Abstract

Background University Medical Centers (UMCs) must do their part for clinical trial transparency by fostering practices such as prospective registration, timely results reporting, and open access. However, research institutions are often unaware of their performance on these practices. Baseline assessments of these practices would highlight where there is room for change and empower UMCs to support improvement. We performed a status quo analysis of established clinical trial registration and reporting practices at German UMCs and developed a dashboard to communicate these baseline assessments with UMC leadership and the wider research community. Methods and findings We developed and applied a semiautomated approach to assess adherence to established transparency practices in a cohort of interventional trials and associated results publications. Trials were registered in ClinicalTrials.gov or the German Clinical Trials Register (DRKS), led by a German UMC, and reported as complete between 2009 and 2017. To assess adherence to transparency practices, we identified results publications associated to trials and applied automated methods at the level of registry data (e.g., prospective registration) and publications (e.g., open access). We also obtained summary results reporting rates of due trials registered in the EU Clinical Trials Register (EUCTR) and conducted at German UMCs from the EU Trials Tracker. We developed an interactive dashboard to display these results across all UMCs and at the level of single UMCs. Our study included and assessed 2,895 interventional trials led by 35 German UMCs. Across all UMCs, prospective registration increased from 33% (n = 58/178) to 75% (n = 144/193) for trials registered in ClinicalTrials.gov and from 0% (n = 0/44) to 79% (n = 19/24) for trials registered in DRKS over the period considered. Of trials with a results publication, 38% (n = 714/1,895) reported the trial registration number in the publication abstract. In turn, 58% (n = 861/1,493) of trials registered in ClinicalTrials.gov and 23% (n = 111/474) of trials registered in DRKS linked the publication in the registration. In contrast to recent increases in summary results reporting of drug trials in the EUCTR, 8% (n = 191/2,253) and 3% (n = 20/642) of due trials registered in ClinicalTrials.gov and DRKS, respectively, had summary results in the registry. Across trial completion years, timely results reporting (within 2 years of trial completion) as a manuscript publication or as summary results was 41% (n = 1,198/2,892). The proportion of openly accessible trial publications steadily increased from 42% (n = 16/38) to 74% (n = 72/97) over the period considered. A limitation of this study is that some of the methods used to assess the transparency practices in this dashboard rely on registry data being accurate and up-to-date. Conclusions In this study, we observed that it is feasible to assess and inform individual UMCs on their performance on clinical trial transparency in a reproducible and publicly accessible way. Beyond helping institutions assess how they perform in relation to mandates or their institutional policy, the dashboard may inform interventions to increase the uptake of clinical transparency practices and serve to evaluate the impact of these interventions.

Improving research transparency with individualized report cards: A feasibility study in clinical trials at a large university medical center

“…The report cards require a structured trial transparency dataset, i.e., a dataset of clinical trials and their performance across several transparency practices. We previously developed methods to assess transparency practices for a cohort of trials using a combination of automated and manual approaches, which are described in detail elsewhere (Franzen et al, 2023; Franzen, 2023; Riedel et al, 2022; Salholz-Hillel et al, 2022). Supplement 4 summarizes the main steps to prepare a trial transparency dataset for use with the report cards.…”

“…In turn, the French Open Science Monitor shows the evolution at the national level of several open science practices, such as open access and mentions of data sharing in publications (Jeangirard, 2019). These initiatives and others (Barbers et al, 2022; Diprose et al, 2023; Franzen et al, 2023; QUEST Center for Responsible Research, Berlin Institute of Health at Charité Universitätsmedizin Berlin, n.d.) provide baseline information against which change can be measured and empower efforts to drive research transparency.…”

Methylphenidate for Children and Adolescents with Attention Deficit Hyperactivity Disorder (ADHD) – unpublished or unregistered randomised clinical trials

“…Research waste and late publishing of randomised clinical trials are areas that have received increased focus as of late [3]. A recent study of German University Medical Centers found that prospective registration of interventional trials, within all therapeutic areas, had increased from 33% to 75% between 2009 and 2017 in ClinicalTrials.gov.…”

“…A recent study of German University Medical Centers found that prospective registration of interventional trials, within all therapeutic areas, had increased from 33% to 75% between 2009 and 2017 in ClinicalTrials.gov. However, only 41% of included trials had published their result within 2 years of trial completion and 31% had not published their result even after 5 years of trial completion [3].…”

Reporting of interventional clinical trial results in a French academic center: a survey of completed studies

“…The proportion of clinical trials reporting their results in timely manner can be monitored with tools such as the FDAAA Trials Tracker (7) for trials initiated in the USA, or the EU Trials Tracker (8) for trials initiated in the European Union. Although there has been improvement, with an increase from 50% in 2018 to 84% in late 2022 (9), communication of results either by posting results on registries or by publications remains suboptimal (10) (11). The lowest proportions are observed for academic sponsors (12), with some heterogeneity across countries, with France registering among the lowest proportions (13).…”