A survey conducted by the Clinical Trials Transformation Initiative (CTTI) indicates a large part of the lack of reported trial results in the U.S. is due to investigators’ and other stakeholders’ limited understanding of the requirements and processes for registering and submitting trial data to the ClinicalTrials.gov database.

Of the responding 92 individuals across 84 organizations, primarily sites and sponsors, more than half (52.2 percent) cited a lack of understanding of the types of trials they’re required to register on the site, while a lesser but still significant portion were unclear on their own internal registration policies (40.2 percent) and when to register trials (41.3 percent), according to the CTTI report.

Similarly, 51.1 percent of respondents listed a lack of well-specified and measurable outcomes in trial protocols that meet ClinicalTrials.gov requirements as a registration challenge.

Getting in touch with principal investigators (PI) and study leads about trial registration was also a major obstacle, according to the survey results, with 47.8 percent of respondents citing nonresponsive PIs/study leads as a hurdle to compliance.

A lack of compliance with the U.S. legally mandated ClinicalTrials.gov requirements has become a key focus of recent efforts to increase trial transparency, with calls for FDA to enforce requirements through monetary fines it is armed by law to levy. Despite criticism and alleged slowness on the part of the agency, no fines have been issued.

Less than one year ago, researchers found that nearly four dozen pediatric trials failed to share their findings on ClinicalTrials.gov despite being required to (CenterWatch Weekly, Jan. 30, 2023).

CTTI, created through a joint effort between Duke University and FDA in 2007, engages in various initiatives to increase the quality and efficiency of trials, including projects, meetings and research to identify hurdles and opportunities for transparency.

Results Reporting

Similar to trial registration, a large number of respondents cited PI/study lead unresponsiveness (43.5 percent) and understanding of responsibilities as major hurdles to the reporting of their trials’ summary results information. Specific challenges related to the understanding of responsibilities include:

• What trial results information must be submitted (56.5 percent)
• Regulatory timelines for submission (51.1 percent)
• When to report results information for unsuccessful trials (48.9 percent)
• Why results information must be submitted if they’ve been published already (48.9 percent)
• Internal policies for filing results information (42.4 percent)

Respondents also listed a number of concerns as barriers to compliance, including responsible parties waiting for all data to be analyzed prior to reporting results information (56.5 percent), the ability to publish if results are put on ClinicalTrials.gov before publication (43.5 percent), and the sharing of competitive data (40.2 percent).

Additionally, one-third of respondents listed a lack of understanding and clear guidance on what is considered accurate and complete information when reporting.

The survey also questioned respondents on the ways their administrative personnel learned of registration and reporting needs for their organizations’ clinical research, as well as strategies they felt could support ClinicalTrials.gov compliance efforts.

For example, in the report’s summary of suggested practices, CTTI recommends responsible parties and administrative teams optimize their collaborative efforts when possible to allow for communication, greater compliance and support in handling challenges with reporting trial results.

Additionally, “take a centralized approach to meeting ClinicalTrials.gov requirements” by using an administrative unit that oversees and/or handles these compliance efforts, the report suggests.

“Administrative units provide a single source of knowledge and assistance for PIs/study teams on ClinicalTrials.gov registration and results information submission requirements. These units can monitor and control records, conduct quality review and stay abreast of ClinicalTrials.gov updates,” it reads.

Access the full CTTI report here.