Individual Participant Data (IPD) sharing plan statement: a Clinical Trial Registry perspective.

Date & Time
Wednesday, September 6, 2023, 12:30 PM - 2:00 PM
Location Name
Session Type
Understanding and using evidence
Malinga T1, Mathebula L1, Ndwandwe D1, May P1, Thabetha A1
1Cochrane South Africa, South African Medical Research Council, SA

Background: Data sharing has been increasingly recognized as a vital prerequisite for scientific research. Therefore, it is advocated that prospective clinical trials be registered in a clinical registry such as Pan African Clinical Trial Registry (PACTR) and South African Clinical Trial Registry (SANCTR) in an effort to reduce publication and reporting bias. The World Health Assembly resolution has made it a point to enforce sharing the results of trials in the public domain. To promote clinical trial data transparency, PACTR and SANCTR registries collect information on individual participant data (IPD) sharing statements as part of the registration process.
Objectives: We examined the reporting of IPD sharing plan statements in PACTR, the only African World Health Organization (WHO) primary registry, as well as the national registry SANCTR.
Methods: We searched and downloaded data in excel format in the clinical registry from 6 September 2022 and 21 September 2022, respectively. The total number of records reviewed was n = 2295. We assessed the researchers’ responses on the IPD sharing statement field for the studies registered from 2019 to the date of the search. Furthermore, we analyzed the IPD sharing statements collected as part of the reporting field in the registries, and we completed a descriptive analysis of these findings.
Results: Of the n=2295 records trial records, 10% were analyzed, 87.4% (201/230) had the intent to share, 3.04% (7/230) had no intention to share, and 9.57% (22/230) did not have any information. Although 87.4% of trial records indicated that they would share data, several descriptions of IPD sharing plans reflects confusion or uncertainty about the IPD description and the meaning of the term IPD sharing.
Conclusions: Based on our observation, data sharing still appears to depend on the enthusiasm of the lead researcher, despite it being widely agreed that IPD should be easily available. The gap in evidence base impact of IPD sharing remains a challenge, especially in the African region. Thus, more high-level evidence is needed to assess whether researchers understand the impact of data sharing when conducting research. Patient, public, and/or healthcare consumer involvement: No.