Abstract
BackgroundSharing interim result measures by the Data Safety Monitoring Board (DSMB) with non-DSMB members is an important issue that can affect trial integrity. Currently, it is unclear if there are demographic factors associated with sharing such information. This study’s objective is to primarily explore the demographic factors associated with the DSMB sharing certain interim result measures and secondarily, explore demographic factors associated with the perceived usefulness in sharing certain interim result measures, with non-DSMB members.MethodsWe conducted an online survey of members of the Society of Clinical Trials (SCT) and International Society of Clinical Biostatistics (ISCB) in 2015 asking their professional views on the DSMB sharing interim trial results, specifically the interim control event rate (IControlER), interim combined even rate (ICombinedER), adaptive conditional power (ACP) and unconditional conditional power (UCP) with non-DSMB members. Binary logistic and multiple linear regressions were used to explore if demographic factors were associated with sharing a certain interim result measure and the perceived usefulness of sharing that interim result measure, respectively. Multiple imputation (MI) was used to evaluate the impact of missing data as a sensitivity analysis.ResultsApproximately 3136 (936 from SCT + ~ 2200 from ISCB) members were invited (response rate of 12%; [371/3136]. Two main findings: (1) involvement in more than 15 private industry-sponsored trials was associated with not endorsing the sharing of the IControlER (odds ratio [OR] = 2.92; 95% confidence interval [CI]: 1.31, 6.52]; p = 0.012), and (2) involvement in more than 15 private industry-sponsored trials was associated positively with an increase in the perceived usefulness in sharing the ACP by 2.35 points (beta coefficient estimate = 2.35 [95% CI: 0.45, 4.05], p = 0.017. The findings were similar after sensitivity analyses.ConclusionsAn individual involved with more than 15 trials that had some form of private industry sponsorship is a demographic factor associated with NOT sharing the IControlER by the DSMB and an increased perceived usefulness in sharing the ACP at interim. Further studies are needed to evaluate for these demographic factors given the limitations of this study related to missing data. Due to some key limitations, regarding high non-response and missing data, we caution interpreting the results as definitive, but rather look at them as a first exploratory step to find potential associations for further evaluation.
Highlights
Sharing interim result measures by the Data Safety Monitoring Board (DSMB) with non-Data Safety Monitoring Boards (DSMBs) members is an important issue that can affect trial integrity
Responses about sharing the IControlER, ICombinedER, adaptive conditional power (ACP), and unconditional conditional power (UCP) and perceived usefulness in sharing Table 2 shows the results based on the responses regarding what interim result measure should be shared by the DSMB of a trial with non-DSMB members and their perceived usefulness of sharing a certain interim result measures if they indicated that interim result measures should be shared
The only interim result measure the majority of respondents thought should be shared with non-DSMB members by the DSMB was the ICombinedER (168/262; 64.1% [95% confidence intervals (95% CIs): 58.0, 69.9])
Summary
Sharing interim result measures by the Data Safety Monitoring Board (DSMB) with non-DSMB members is an important issue that can affect trial integrity. It is unclear if there are demographic factors associated with sharing such information. As a second part analysis of this survey [8] using this survey’s data, the aim was to explore if there were demographic factors associated with thinking the ICombinedER, IControlER, ACP or the UCP should be shared by the DSMB with non-DSMB members and an individual’s perceived usefulness of sharing any of these four interim results measures. Evidence from this study could help us see if certain demographic groups appear to have an interest in particular interim result measures being shared and how useful they find that information, as well as promote future research to see why those groups have that interest
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