An Opinion and Practice Survey on the Structure and Management of Data and Safety Monitoring Boards

Abstract

There is little to no empirical data available on how data and safety monitoring boards (DSMBs) are structured and how they operate. The purpose of this study was to provide data on this. To accomplish this goal, we administered a random survey on current structure and management practices and opinions as reported by principal investigators (PIs) and biostatisticians. We also surveyed Institutional Review Board (IRB) community members, as proxies for the public, as to their opinions on how DSMBs should be structured and managed. A final purpose was to compare opinions about what should be taking place to what is actually happening.

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

“…The remaining four of the six surveys report results quantitatively. The target populations for these surveys varied, ranging from directors of the statistical centres from 12 cancer cooperative groups sponsored by the National Cancer Institute (NCI) in the USA from 1993 [11], trialists of past and ongoing trials [5, 12], PIs and biostatisticians on DSMBs and Institutional Review Board (IRB) community representatives [13], major funders of trials, regulatory agencies and other relevant organisations related to trial research [5]. Methods to obtain the sample also varied.…”

“…Sampling frames included statistical centres from 12 cancer cooperative groups sponsored by the NCI in the US in 1993 [11], the US National Institutes of Health (NIH) [12], ClinicalTrials.gov, a MEDLINE search of articles pertaining to randomised controlled trials (RCTs) from Biometrics or Statistics in Medicine, the Office of Human Research Protection website [13], a database of Health Technology Assessment (HTA) programme and Medical Research Council (MRC) trials [5] and a list of 25 handpicked organisations that are major funders of trials, regulatory agencies and other relevant organisations related to trial research [5]. Response rates ranged from 40% to 100% [5, 11–13]. The number of responses to these surveys varied from 12 to 309 [5, 11–13].…”

“…Response rates ranged from 40% to 100% [5, 11–13]. The number of responses to these surveys varied from 12 to 309 [5, 11–13]. Respondents were not chosen at random in two cases [11, 12].…”

“…Respondents were not chosen at random in two cases [11, 12]. The other four surveys had some method to select respondents at random [5, 13]. Survey collection methods included telephone interviews [5], email surveys [5] and mail/paper surveys [5, 11–13].…”

“…Who had access to interim data or results was as follows:41% of respondents (7) indicated that everyone has access to interim data or results except the participants35% of respondents (6) indicated that key institute staff has access to interim data or results• 1 respondent from this group said there was also provision for interim data to be seen occasionally and confidentially by the DSMB of another trial18% of respondents (3) indicated that only the trial statistician and the DSMB had access to interim data or results6% of respondents (1) allow data centre personnel to access interim data or resultsAll respondents from major agencies that are involved in trials indicate that interim data or results are shared with certain non-DSMB members. The largest minority of respondents (41%) indicate interim data/results are shared with everyone except the participants.2011[13]PIs and biostatisticians on DSMBs and IRB community representativesTotal n  = 309Response rate:31% from PIs51% for biostatisticians40% from IRB community members n  = 246PIs = 152Biostatisticians = 40IRB community members = 54• 100% of Biostatisticians (40) indicate that sponsor should be masked to interim data or results• 78.3% of PIs (119) indicate that the sponsor should be masked to interim data or results• 63.0% of IRB community members (34) indicate that the sponsor should be masked to interim data or resultsThe majority of PIs and biostatisticians on DSMBs and IRB community representatives believe that the sponsor should be masked to interim data or results.Details about sharing with other non-DSMB members were not discussed IRB Institutional Review Board, NCI National Cancer Institute, NIH National Institutes of Health for the USA, SC Steering Committee, PI Principal Investigator, UK United Kingdom …”