Should data and safety monitoring boards share confidential interim data?
Consider the following situation: Two clinical trials are underway, closely related in terms of the interventions being compared and the target populations. In preparing for a planned interim analysis, the statistician for trial 1 finds that the results support a recommendation to stop the trial early. Should the statistician ask the investigators for trial 2 to make interim results of their trial available to the data and safety monitoring board (DSMB) for trial 1? If so, in what form? Would the answers change if the trial 1 results showed a strong but not convincing trend? What is the obligation of the trial 2 investigators to respond to such a request? What role do the two DSMBs have, either in initiating a request or in agreeing to respond to it? In this article, we examine this situation in some detail, having faced it occasionally in our own experience with clinical trials and DSMBs. The chief argument in favor of sharing data is that data from trial 2 are obviously relevant to the question being addressed by trial 1 and therefore ought to be available to those who must interpret the results from that trial. On the other hand, there are several reasons for not sharing interim data. For example, sharing is incompatible with the independence of the trials; the time for synthesizing evidence from both trials is after the two teams of investigators have presented the full analysis and interpretation of their separate trials. For this and other conceptual and practical reasons we conclude that it is better, in most cases, for DSMBs to consider only information that has already been made public in some form.
Dixon
D O
DO
Biostatistics Research Branch, Division of AIDS, National Institute of Allergy and Infectious Diseases, Bethesda, Maryland 20892-7620, USA.
Lagakos
S W
SW
D002986:Clinical Trials as Topic / Q000379:methods*; D003219:Confidentiality; D006801:Humans; D007373:Interinstitutional Relations; D017751:Safety Management