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It has been suggested that individual participant data (IPD) meta-analyses of randomised controlled trials are the ‘gold standard’ approach to systematic review, allowing the most robust and unbiased assessment of research evidence to provide the most accurate information regarding the efficacy of a therapy.1 Such projects aim to collect raw line by line participant data from a range of relevant studies, often with updates of their outcome measures. The value of the IPD approach to review predictive studies, those assessing prognostic markers, clinical prediction rules or diagnostic tests, has also been stated.2
In forming an international collaborative to find clinical variables that predict the outcome of children and young people presenting with febrile neutropenia, we undertook an investigation into the ethical and regulatory considerations involved in sharing such information for our projects. This paper reports the outcome of our work to help inform the practice of others.
It has been suggested that the reuse of IPD from randomised trials within meta-analyses that address the same clinical questions should be exempt from further ethical review requirements. This is because the data are from studies which have already obtained individual consent.3 ,4 The use of data that had been obtained outside specific research studies, or where the meta-analysis has different aims, …