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. 2022 Apr 11;6(1):e49.
doi: 10.1017/cts.2022.387. eCollection 2022.

Securely sharing DSMB reports to speed decision making from multiple, concurrent, independent studies of similar treatments in COVID-19

Natalie A Dilts  1 , Frank E Harrell  2   3 , Christopher J Lindsell  1   2   3 , Samuel Nwosu  2 , Thomas G Stewart  2 , Matthew S Shotwell  2 , Jill M Pulley  1 , Terri L Edwards  1 , Emily Sheffer Serdoz  1 , Katelyn Benhoff  1 , Gordon R Bernard  1   3
Affiliations

Securely sharing DSMB reports to speed decision making from multiple, concurrent, independent studies of similar treatments in COVID-19

Natalie A Dilts et al. J Clin Transl Sci. .

Abstract

Introduction: As clinical trials were rapidly initiated in response to the COVID-19 pandemic, Data and Safety Monitoring Boards (DSMBs) faced unique challenges overseeing trials of therapies never tested in a disease not yet characterized. Traditionally, individual DSMBs do not interact or have the benefit of seeing data from other accruing trials for an aggregated analysis to meaningfully interpret safety signals of similar therapeutics. In response, we developed a compliant DSMB Coordination (DSMBc) framework to allow the DSMB from one study investigating the use of SARS-CoV-2 convalescent plasma to treat COVID-19 to review data from similar ongoing studies for the purpose of safety monitoring.

Methods: The DSMBc process included engagement of DSMB chairs and board members, execution of contractual agreements, secure data acquisition, generation of harmonized reports utilizing statistical graphics, and secure report sharing with DSMB members. Detailed process maps, a secure portal for managing DSMB reports, and templates for data sharing and confidentiality agreements were developed.

Results: Four trials participated. Data from one trial were successfully harmonized with that of an ongoing trial. Harmonized reports allowing for visualization and drill down into the data were presented to the ongoing trial's DSMB. While DSMB deliberations are confidential, the Chair confirmed successful review of the harmonized report.

Conclusion: It is feasible to coordinate DSMB reviews of multiple independent studies of a similar therapeutic in similar patient cohorts. The materials presented mitigate challenges to DSMBc and will help expand these initiatives so DSMBs may make more informed decisions with all available information.

Keywords: Data and Safety Monitoring Boards (DSMBs); data harmonization; data sharing/pooling; safety monitoring; trial monitoring.

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Conflict of interest statement

The author Christopher J. Lindsell is both a blinded biostatistician on the PassItOnII trial and member of the DSMBc initiative. The author Thomas G. Stewart is both an unblinded biostatistician on the PassItOnII trial and member of the DSMBc initiative.

Figures

Fig. 1.
Fig. 1.
DSMBc engagement timeline.
Fig. 2.
Fig. 2.
Data and Safety Monitoring Board Coordination (DSMBc) hReport process.
See this image and copyright information in PMC

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