Abstract
BACKGROUND: Data monitoring committees play a critical role in ensuring the ethical conduct of clinical trials. Data monitoring committee charters set out the role and processes for data monitoring committees in monitoring clinical trials; however, little is known about the information charters contain. METHODS: We conducted a summative content analysis of a convenience sample of data monitoring committee charters based on the criteria set out for charters by the DAMOCLES Study Group in 2005. Thirteen charters from public and commercially sponsored clinical trials were obtained for review. RESULTS: Although the data monitoring committee charters we analyzed broadly satisfied the criteria set out by the DAMOCLES Study Group, some issues warrant further attention. These included variability in the availability of unmasked data for review, communication across data monitoring committees for related trials, post-trial DMC responsibilities, and a need for more explicit decision-making processes and conflict resolution procedures. Moreover, few of the data monitoring committee charters we were able to analyze included legal protection for members. CONCLUSION: Despite limitations due to the difficulties in obtaining data monitoring committee charters, the convenience sample reviewed suggests variability, including in terms of implementation of some best-practice recommendations. There is a need for further exploration of these issues in a larger sample size. Undertaking such research would be assisted by requiring or incentivizing public access to data monitoring committee charters.