![Sample our Bioscience journals, sign in here to start your access, Latest two full volumes FREE to you for 14 days]({"type":"image" , "src" : "/sda/5925/TOC-Subject-Sample-2021-Bioscience.jpg"})
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.
Keywords:
Notes
Deborah A. Kermer is currently at the Analyst Institute in Washington, D.C., USA.
*This research was supported by a Grant from the Greenwall Foundation.
1. We have intentionally chosen not to study ethicists' roles on DSMBs We believe that the role of ethicists is worthy of a separate study on just this topic, which we hope to pursue in the future. As discussed in this paper, it is still the subject of debate as to whether ethicists should be and are included routinely as members of DSMBs, and our data reveal that the great majority of DSMBs have no ethicist member.
2. Statistical comparisons across groups were computed using the Fisher's Exact test for two groups and a Pearson chi-square for more than two groups. Comparisons of experiences and opinions were conducted using a paired t-test for two responses and a within-subjects general linear model (GLM) with the Hyunh–Feldt correction for more than two responses.
3. The adjusted rate is computed following AAPOR standards. American Association for Public Opinion Research (AAPOR). Standard Definitions: Final Dispositions of Case Codes and Outcome Rates for Surveys. Revised 2008. Available on line at www.aapor.org. The number of unresolved cases in the sample (persons never heard from) is reduced by applying an estimate of the percent of unresolved cases that were ineligible, based on the ineligible percentage among those with whom contact was made. This is equivalent to AAPOR response rate RR3.