November 21, 2019 – Data monitoring committees could be provided more and better data in order to fulfill its role of protecting trial participants.
Data monitoring committees (DMCs) play a critical role in clinical trials by protecting patients—especially in studies involving high-risk populations or potentially harmful treatments—and in order to fulfill this role successfully, these committees should have access to all data at each interim review, wrote the authors of a recent paper published in the Annals of Internal Medicine.
The DCRI’s Frank Rockhold, PhD, and Robert Bigelow, PhD, served on the writing group for the paper, which provided recommendations for summaries produced by statistical data analysis centers (SDACs) and provided to DMCs, or data and safety monitoring boards.
The authors note that often DMCs only receive the data thought necessary for making decisions about safety. However, they argue, when these groups receive limited data and information, they are lacking important context. “To fulfill its mandate to protect trial participants, the DMC needs timely access to all relevant information, including efficacy data,” the authors write.
The paper also identifies problems with reports currently produced by SDACs, which are often lengthy and difficult to digest. “To foster efficient, informed decision making, reports should be streamlined, concise documents that display important data in optimally informative ways,” the authors recommend.
In addition, the authors advocate for implementation of graphical summaries that integrate benefits and harms. Visuals could help the DMCs make more accurate risk-benefit analyses with less room for bias and misinterpretation of the data. The paper walks through several examples of graphical representations that could provide information that would be helpful to the DMC. This will require investment in resources to develop data visualizations, which can then be reused in future trials.
“In writing this paper, we concluded that several immediate steps can be taken to help DMCs do their jobs more effectively,” Rockhold said. “DMCs will only be equipped to protect patients to the fullest extent when they have complete and easily digestible information to guide their decisions.”