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Historically US-based academic organizations dedicated limited resources, including policies, personnel to ensuring compliance with clinical trials registration and results reporting requirements. A recent follow-up survey finds that 6-years after an initial survey, there is increased attention and dedication of resources to improve compliance rates for clinical trials registration and results reporting.
Methods:
Internet-based online survey using Qualtrics between 20 April 2023 and 30 September 2023 distributed to Protocol Registration and Results Reporting (PRS) Administrators at US-based academic organizations with ClinicalTrials.gov organizational accounts. The survey focused on the 249 respondents of the original 2016–2017 survey published in 2018. The overall response rate was 162/249 (65.06%) with 100% participation from National Cancer Center (NCI) Designated Cancer Centers and hubs of the Clinical and Translational Science Awards (CTSA).
Results:
Results indicated a marked increase of academic organizations with policies in place for registration (43 to 74%) and results reporting (35 to 68%). The median number of Full-time Equivalent (FTE) staff at responding academic organizations increased (from 0.08 to 0.5) with statistically significant difference between the number of organizational records and FTEs supporting registration and results reporting. Larger gains are seen with NCI-Designated Cancer Centers and/or CTSA hubs.
Conclusions:
It appears academic organizations are more equipped to comply with requirements, and demonstrate a trend towards appropriate staffing. In the 6 years since the original survey, US-based academic organizations have significantly increased attention to compliance with clinical trials registration and results reporting requirements, indicated by an increase in institutional policies and dedicated personnel.
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