The Debate on Confidentiality of Interim Trial Results

A recent paper has looked at the ethics of keeping interim RCT results confidential.[1] Many hold the view that releasing interim results compromises the integrity of the trial and is against the interests of the patient, but there is little evidence for this. The reasons for confidentially seem to stem from only a few sources of evidence – a study that may have been stopped early due to a significant difference in deaths between arms, which had become non-significant by the end of the trial; and a comparison of trials that found that those that released interim data generally had a decline in accrual, though there were many other differences.

Stephens et al. argue that, under specific circumstances, it is possible to release interim results without compromising integrity or credibility, and that this can enable difficult trials to continue and be successfully completed. They provide two examples of this – the QUARTZ trial, which looked at radiotherapy for patients with inoperable brain metastases; and the GRIT trial, which compared two obstetric strategies for delivering foetuses. They provide a number of factors that may be considered when assessing whether a trial should release interim results. It appears that there is a need for further debate regarding the current views on releasing interim data.

— Richard Lilford, Director CLAHRC WM

References:

  1. Stephens RJ, Langley RE, Mulvenna P, Nankivell M, Vail A, Parmar MKB. Interim results in clinical trials: Do we need to keep all interim randomised clinical trial results confidential? Lung Cancer. 2014. [In Press].
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