Objective To quantify the administrative demands and timeliness of sharing individual participant data and identify the main choke points for researchers and contracts departments.

Design This mixed-methods study conducted in 2022 included 2 case studies of individual participant data meta- analyses, Individual Participant Data on Cord Management at Preterm Birth (iCOMP) and Transforming Obesity Prevention for Children (TOPCHILD), for which data were requested from international trials from 2019 until May 2022. Each contact with trial investigators was logged in custom-built software. From these logs, contact time points, study characteristics (eg, year, sample size, country), email texts, and data-sharing status were extracted. Researchers responsible for negotiating agreements were interviewed to identify choke points. The median, IQR, and range of time from the first data request until data receipt were calculated, and the number of emails required was tallied. Emails, data-sharing agreements, reasons data could not be shared, and interview responses were analyzed qualitatively using a thematic analysis to identify choke points and facilitators.

Results For 71 of 72 included trials (50 iCOMP trials 69%, 22 TOPCHILD trials 31%), data were directly requested and supplied from investigators. Only 1 data set was available as a publication supplement; none used data repositories. The median (IQR) time from requesting to receiving data was 88 days (130 days). The longest completed request took 831 days (ie, >2 years). A mean of 23 emails (SD, 25; range, 4-49 emails) were sent until data were received. While some data were shared in the requested format (26 trials 36%), other data sets had to be recoded (46 trials 64%), and substantial contact with the investigators was required for this. Workload and duration to set up data sharing agreements were reduced if institutions had executed agreements together previously. For 3 studies, data were not shared despite investigators being eager to do so because institutional approval could not be obtained. For iCOMP, 7 requests remained in progress after 854 days; for TOPCHILD, 9 requests were in progress after 272 days. Most data sharing agreements were similar in content but varied in detail and length (3-36 pages). The largest choke points included differences in regulations across jurisdictions and varying stakeholder expectations of rights and responsibilities (eg, institutional expectations about data storage, authorship rights). However, most emails dealt with minor change requests and clarifications.

Conclusions This study’s results demonstrate major delays in the process of data sharing from trials with requests remaining unresolved after 2 years. The similarities identified across agreements indicate opportunities for standardization. Data sharing delays consume financial resources and impair the timeliness of research, which is particularly problematic for research endeavors linked to emergency situations (such as the COVID-19 pandemic). Many researchers are willing, or required by journals and funders, to share their data. To overcome costly choke points and delays, streamlined standards and infrastructure are needed.

Funding/Support Anna Lene Seidler receives research funding support from a National Health and Medical Research Council (NHMRC) investigator grant (GNT2009432). Kylie E. Hunter receives research funding support via 2 scholarships administered by the University of Sydney (Postgraduate Research Supplementary Scholarship in Methods Development SC3504 and Research Training Program Stipend SC3227). TOPCHILD is supported by an NHMRC ideas grant (GNT1186363); iCOMP is supported by an NHMRC project grant (GNT1163585).

Role of the Funder/Sponsor The funders had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the abstract; and decision to submit the abstract for presentation.

Acknowledgment We acknowledge all members of the iCOMP collaboration (https://www.icompstudy.org/) and TOPCHILD collaboration (https://www.opchildcollaboration .org/) for their assistance with preparing and executing data sharing agreements and sharing their data despite the barriers they encountered.