CONTRAST

CalifOrNia TRiAlS Transparency (CONTRAST)

Background

The prospective registration of clinical trials and their timely and open results reporting is a crucial aspect of evidence-based health care and responsible research. Since its 2008 revision, the Declaration of Helsinki describes registration and reporting for all clinical studies as core principles that make human subject research ethical (1). The WHO further specified in 2017 that results reporting should be timely (within 2 years after study completion) and that publications should be openly accessible (2). While the transparency principles of the Declaration of Helsinki and the WHO address all clinical trials, national legislation often captures only subgroups of trials, namely trials on drugs, biologicals, or devices (e.g. the FDAAA 801 and the Final Rule) (3). Medical schools conducting clinical trials must do their part to meet these ethical principles for clinical research. However, research institutions are often unaware of their performance in these fundamental registration and reporting practices or primarily focus on compliance with legal requirements for the smaller group of trials where these may apply. Baseline assessments of these registration and reporting practices for all clinical trials would highlight where there is room for change and empower medical schools to seek improvement. Follow-up studies from Medical Schools in the US (4) and Germany (5) found that only 36% and 43% of trials, respectively, were published within 24 months after study completion.

Objectives

The primary objective of CONTRAST is to analyze the transparency, specifically prospective registration and timely and open results reporting, of clinical trials completed between 2014-2017 and led by seven California medical schools: 1) Stanford University; 2) University of California, Davis; 3) University of California, Irvine; 4) University of California, Los Angeles; 5) University of California, San Diego; 6) University of California, San Francisco, 7) University of Southern California.

The secondary objectives are: I) to compare the results with a similar cross-sectional study for trials completed between 2014-2017 conducted on German university medical centers (5) and II) compare them with trials completed between 2007-2010 from the seven California medical schools (4). Another secondary objective is to develop a medical school specific dashboard for clinical trial transparency for the seven California medical schools.

Methodology

A detailed methods description can be found on the project page at OSF: https://osf.io/u9d5c/.

Perspectives

Based on our experiences for feasibility and needed resources in CONTRAST, we aim to discuss with interested partners the further development of this approach for more trials (with more recent completion years) and for more medical schools. The resulting datasets will also allow us to analyze opportunities to make the planned assessments of registration and reporting performance more efficient as well as to design interventions to increase registration and reporting in ClinicalTrials.gov.

References

1. WMA - The World Medical Association-WMA Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects [Internet]. [cited 18. May 2022]. Available from: https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/
2. WHO Statement on public disclosure of clinical trial results [Internet]. 2015 [cited 18. Mai 2022]. Available from: https://www.who.int/news/item/09-04-2015-japan-primary-registries-network
3. FDAAA 801 and the Final Rule - ClinicalTrials.gov [Internet]. [cited 18. Mai 2022]. Available from: clinicaltrials.gov/ct2/manage-recs/fdaaa
4. Chen R, Desai NR, Ross JS, Zhang W, Chau KH, Wayda B, u. a. Publication and reporting of clinical trial results: cross sectional analysis across academic medical centers. BMJ. 17. Februar 2016;352:i637.
5. Riedel N, Wieschowski S, Bruckner T, Holst MR, Kahrass H, Nury E, u. a. Results dissemination from completed clinical trials conducted at German university medical centers remained delayed and incomplete. The 2014 -2017 cohort. J Clin Epidemiol. April 2022;144:1–7.