Abstract
Over the past three decades it has become increasingly recognized that systematic assessment of as high a proportion as possible of relevant research evidence is needed to protect the best interests of patients and the public. For example, this principle is manifested in clinical guidelines and, increasingly, in the design and monitoring of new research. For scientific and ethical reasons, those responsible for monitoring the progress of ongoing clinical trials may need to seek unpublished and interim data to protect the interests of actual or potential participants in research. The challenge facing data monitoring committees has received relatively little attention, however. In this paper we review some of the commentaries on the issue and the few accounts of actual data monitoring committee experiences. We then present details of our own recent experience as members of the data monitoring committee for the BOOST-II UK trial (ISRCTN:0084226), one of five concurrent trials assessing the level of arterial oxygen which should be targeted in the care of very premature neonates. We conclude that efficient protection both of the interests of actual or potential participants in research and of science requires that data monitoring committees have access to all relevant research, including unpublished and interim data.
Highlights
Taking account of all relevant evidence when planning randomized trials Science is cumulative, and scientists should accumulate scientifically
A decade ago, Dixon and Lagakos [18] noted that it is expected that Data Monitoring Committee (DMC) will base their recommendations on ‘all available relevant information, even if they must go to some extra trouble to get it’
Given the evidence that DMC decisions based on analyses of all relevant evidence, unpublished as well as published, can be very important for patients and science, any arguments against sharing interim data confidentially among DMCs that are monitoring related trials need to be very persuasive, on both ethical and scientific grounds
Summary
Taking account of all relevant evidence when planning randomized trials Science is cumulative, and scientists should accumulate scientifically. When one of the trials (the US trial) in the NeOProM Collaboration reported a difference in mortality of marginal statistical significance [8], the other four DMCs responsible for the related ongoing trials commissioned new analyses based on interim data from their respective studies None of these analyses were judged to provide any grounds for discontinuing recruitment. Given that the Canadian trialists had ceased recruitment (because they had enrolled their target sample size), the conduct of their trial could not be influenced by shared access to all the relevant data available Their decision not to share their data had major consequences for the two DMCs (UK and Australasian) that remained responsible for monitoring their ongoing trials. The TSCs decided independently of each other to cease recruitment to their respective trials; and they subsequently reported this decision and the collaborative analyses which had led to their decisions in a letter published in the New England Journal of Medicine [17]
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