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01.12.2017 | Review | Ausgabe 1/2017 Open Access

Trials 1/2017

Sharing interim trial results by the Data Safety Monitoring Board with those responsible for the trial’s conduct and progress: a narrative review

Zeitschrift:
Trials > Ausgabe 1/2017
Autoren:
Victoria Borg Debono, Lawrence Mbuagbaw, Lehana Thabane
Wichtige Hinweise

Electronic supplementary material

The online version of this article (doi:10.​1186/​s13063-017-1858-y) contains supplementary material, which is available to authorized users.

Abstract

Background

Sharing interim data, results or result extrapolations is an important issue that can affect trial integrity. The different ways in which Data Safety Monitoring Boards (DSMBs) share interim results with non-DSMB members and the acceptability of such practices are poorly understood. Our objective was to undertake a narrative review specifically on what kind of interim results, if any, should be shared by the DSMB with non-DSMB members and why.

Methods

We conducted a narrative review using a systematic search strategy of several databases and major health research stakeholders. Literature was included if there was some discussion within the full text about sharing interim trial results with non-DSMB members.

Results

About 79.6% (129/162) of included citations were based on author’s views, 16.7% (27/162) on research guidelines and 3.7% (6/162) on surveys. The largest group of citations, 73/162 (45%), expresses the opinion or argument against sharing interim results with exceptions. Trailing closely, 71/162 (43.8%) of the included citations support the opinion or argument that interim results should not be shared and should remain confidential with the DSMB. Half of the six surveys support sharing in some capacity, while the other three do not. Eleven circumstances were found that potentially warrant interim result sharing by the DSMB; they relate to (1) usual practices by DSMBs, (2) trial completion threatened, (3) patient safety, (4) regulatory approval and (5) other circumstances. Dominant risks for sharing under these conditions are associated with introducing trial bias.

Discussion/conclusion

There was no majority view in the literature. However, the largest group of citations included express the idea that interim results should remain confidential with the DSMB but also acknowledge circumstances when they could be shared with non-DSMB members. Limitations of this review are that (1) the included literature predominately provides personal perspectives, not evidence, and (2) surveys found globally focus on trial monitoring practices lacking detailed information on what specifically to share, with whom and why. More research is needed with the use of a detailed survey of the clinical trial community focused on DSMB sharing interim results, to better understand and guide DSMB interim result sharing practices.
Zusatzmaterial
Additional file 1: Search strategies for literature. (DOCX 33 kb)
13063_2017_1858_MOESM1_ESM.docx
Additional file 2: Citations of included articles for review. (DOCX 33 kb)
13063_2017_1858_MOESM2_ESM.docx
Additional file 3: RAMESES checklist. (DOCX 18 kb)
13063_2017_1858_MOESM3_ESM.docx
Literatur
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