Skip to main content
. 2023 May 23;12(11):3625. doi: 10.3390/jcm12113625
30 March 2022. The DSS of the study as published on this date promised access to its “complete de-identified data set” at the ICODA data repository beginning “immediately after publication” [26].
10 May 2022. A letter from 66 scientists and physicians requesting the study’s four outcome numbers of key importance, PP death and hospitalization rates, IVM vs. placebo, was emailed to study coauthors, and copied to 39 scientists and science journalists [24].
10 May 2022. TOGETHER trial coauthor David Boulware replied, declining to provide those outcome numbers and directing the letter signatories to the ICODA data repository [25].
7 June 2022. An ICODA manager sent an email to a scientist who had inquired about this data, stating “ICODA does not hold the data and we have requested that the authors update the data sharing agreement to reflect that” [28].
8 June 2022. Three of us (DES, CA, EJF) emailed the TOGETHER trial coauthors and cc’s of the above-cited email thread, quoting the above statement from that ICODA manager, that ICODA never hosted the study’s data [24]. The study’s DSS continued to specify the same link to ICODA through 6 July 2022.
7 July 2022. The study’s DSS was changed to link to another data repository, available online: vivli.org (accessed on 20 March 2023) [26].
14 July 2022. An entry for the TOGETHER platform trial appeared on Vivli, matching the NCT number (NCT04727424) for the TOGETHER-IVM study [26]. This vivli.org record, for its “intervention/treatment,” listed three treatment drugs other than IVM, but not IVM [75]. The ClinicalTrials.gov record for the TOGETHER trial, v4, (Available online: https://clinicaltrials.gov/ct2/history/NCT04727424?V_4 (accessed on 15 January 2022)), and also v5, (Available online: https://clinicaltrials.gov/ct2/history/NCT04727424?V_5 (accessed on 3 July 2022)), lists those same three drugs but not IVM as the treatment agents.
19 July 2022. Three coauthors of the current analysis (DES, CA, EJF) emailed study coauthors noting this omission of IVM in the vivli.org record for the TOGETHER trial [24].
21 July 2022. This vivli.org record was changed to include IVM [26].
Vivli’s legal agreement for data access [76], p. 1, references the option for an “alternate review model approved by the relevant Data Contributor,” i.e., the study coauthors, to govern whether an application for data access is approved or rejected.
That Vivli legal agreement also includes the provision for unspecified conditions to be imposed by the study author (“data provider”) and/or Vivli upon use of the data [76], p. 2, Section 1b: “Recipient agrees to comply with any conditions that were placed by the cognizant Data Review Entity(ies) [the data provider and/or Vivli] on Recipient’s use of the Data Sets.” With such latitude for unspecified conditions to be imposed, these could, for example, limit the disclosure of a potential finding of manipulated results.