Communicate, Educate to Improve Trial Registration, Summary Reporting

Communication is key to making sure researchers correctly register and report summary results information for applicable clinical trials on 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, surveyed research stakeholders to discover strategies designed to close gaps in clinical trial registration and results information submission to the databank.[1] 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 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.

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