New study finds strong investments into improving clinical trial reporting by US universities

American academic organisations have significantly increased resources devoted to improving compliance with clinical trials registration and results reporting requirements, a new study shows.

The authors note that these investments have been paralleled by a strong increase in many universities’ compliance with legal clinical trial transparency requirements.

Over the course of six years, the proportion of U.S. organisations with clinical trial registration policies increased to 74%, while the share of organisations with results reporting policies nearly doubled to 68%. Over half of existing policies enabled institutions to penalise researchers who failed to follow the law, and a third included provisions to ensure that trial results are reported even if principal investigators move away to different jobs.

At the same time, institutions significantly increased their investment in specialist support staff. On average, they now have 0.6 full-time equivalent staff members whose job it is to track trial registration and reporting and help investigators to navigate the system.

More than half of the organisations have an electronic system for managing ClinicalTrials.gov compliance.

Multiple drivers for greater transparency

The authors cite several factors driving these positive trends:

• Campaigning by advocacy groups including TranspariMED and Universities Allied for Essential Medicines

• Visibility into universities’ performance through the FDAAA Trials Tracker

• Critical media coverage of non-compliant institutions

• Active measures to drive legal compliance taken by both the largest research funder (NIH) and the medicines regulator (FDA)

• A comprehensive effort to modernize the public ClinicalTrials.gov website that closely involved universities in designing new systems and processes

The study leaves unclear to what extent universites' efforts are limited to improving the transparency of all clinical trials, as opposed to narrow focusing only on those trials that are subject to disclosure laws (FDAAA) and funder requirements (NIH).

How are U.S. universities supporting researchers?

According to the study:

“Staff supporting registration and results reporting efforts perform multiple functions, including: creating and maintaining user accounts (92.0%), reviewing problem records (90.7%), communicating with ClinicalTrials.gov staff (87.7%), notifying researchers about noncompliance sanctions (81.5%), enforcing compliance requirements (79.6%), transferring records between PRS accounts (77.8%), providing individualized support to investigators (74.7%), developing policies (74.1%), coordinating with internal groups (63.0%), and group training (53.7%), maintaining educational websites (46.9%), reviewing data management plans (35.8%) and NIH data dissemination plans (22.2%).”

What’s happening in Europe?

Previous research has found that UK universities have invested significantly into improving their clinical trial registration and reporting (see here and here).

TranspariMED is aware of multiple leading European universities that have set up comparable systems, but there are no comprehensive data on these efforts.

The European Medicines Agency's rollout of the new CTIS drug trial registry was accompanied by significant efforts to inform, train and support European trial sponsors. (TranspariMED’s founder is currently running a study to gauge the extent to which these efforts have translated into improved regulatory compliance.)

About this study

The data on U.S. universities’ policies and human resource investments were collected through a 2023 online survey with 162 respondents that followed up on a similar survey conducted in 2016–2017.

The authors are active in the U.S. Clinical Trials Registration and Results Reporting Taskforce, a network of academic organizations whose representatives meet monthly by teleconference, share resources, and provide informal peer education. Since 2014, the Taskforce has grown to over 700 members at over 250 US-based academic organizations and includes governmental agencies and other relevant partners.

(An effort to set up a similar network in the European Union a few years ago was unsuccessful, leaving European universities unable to access comparable peer-to-peer support.)