Communication is key to making sure researchers correctly register and report summary results information for applicable clinical trials on ClinicalTrials.gov. Moreover, a proactive, centralized approach that also includes education can help improve timely, accurate and complete registration and reporting, according to a report issued in January by the Clinical Trials Transformation Initiative (CTTI) and Food and Drug Administration (FDA).
Authors of the report, Improving Timely, Accurate, and Complete Registration and Reporting of Summary Results Information on ClinicalTrials.gov, surveyed research stakeholders to discover strategies designed to close gaps in clinical trial registration and results information submission to the ClinicalTrials.gov databank. The report details a variety of strategies for improved reporting, starting with better communication.
“Survey respondents cited that the major challenge when registering and reporting summary results information for clinical trials was a lack of understanding on the part of the Responsible Party regarding the types of trials that must be registered, when the trial should be registered, and when and for which trials results information must be submitted,” the report concluded.
Nonresponsive principal investigators (PIs) or study leads also hindered both timely registration and reporting of summary results information, the authors wrote. Additional challenges cited related to the clarity of the requirements. Organizational policies and “lack of harmonization with requirements for other regulatory agencies and registries” also contributed, the report said.
Most survey respondents endorsed taking a proactive, rather than reactive, approach to complying with ClinicalTrials.gov regulatory requirements.
“Survey respondents also suggested that FDA can help by providing resources such as pre-recorded informational sessions, virtual and in-person events, conferences and workshops, and better communication about guidance and compliance actions,” the report said.
A Need to Increase Reporting
CTTI collaborated with FDA to understand the barriers to timely, accurate, and complete registration and reporting of summary results information for applicable clinical trials on ClinicalTrials.gov, which has been identified as a pervasive problem in various studies.
Applicable clinical trials are defined as controlled interventional trials involving “at least one drug, biological, or device product regulated by the FDA with at least one U.S. trial site, or that is conducted under an investigational new drug application or investigational device exemption, or trials involving a drug, biological, or device product manufactured in and exported from the U.S. for study in another country.”
The report pointed out that there are some exceptions because Phase 1 and feasibility trials are excluded and noted that the National Library of Medicine has created a checklist, available on the ClinicalTrials.gov website, to assist responsible parties in determining whether a study is an applicable clinical trial.
The joint CTTI-FDA project involved a survey identifying the range of barriers and their salience by type of stakeholder, root causes influencing barriers and potential solutions and helpful practices to implement moving forward, according to CTTI, which surveyed 92 individuals representing 84 unique organizations. The survey was active from Dec. 12, 2022, to Feb. 1, 2023, and was advertised via CTTI’s communication channels.
In addition to the survey, CTTI project staff contacted groups engaged in clinical trials support activities and related groups, such as the Clinical Trials Registration and Results Reporting Taskforce, the Drug Information Association’s Clinical Trial Transparency Community, and trade organizations for pharmaceutical biotechnology companies and medical device companies to assist in identifying potential candidates for interviews. Ultimately, 26 individuals qualified for interviews, according to the report.