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Interim results in clinical trials: Do we need to keep all interim randomised clinical trial results confidential?

Stephens, RJ; Langley, RE; Nankivell, M; Parmar, MKB; Mulvenna, P; Vail, A; (2014) Interim results in clinical trials: Do we need to keep all interim randomised clinical trial results confidential? Lung Cancer , 85 (2) 116 - 118. 10.1016/j.lungcan.2014.05.012. Green open access

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Abstract

Objectives: Guidelines for the conduct of clinical trials emphasize the importance of keeping the interim results from the main endpoints confidential, in order to maintain the integrity of the trial and to safeguard patients' interests. However, is this essential in every situation? Materials and methods: We review the evidence for these guidelines and consider recent randomised trials that have released interim results, to assess their impact on the success of the trial. However, because the strength of opinion to keep interim results confidential is so strong, there are limited examples of such trials. Results: In the QUARTZ trial (which is assessing the value of whole brain radiotherapy in patients with brain metastases from non-small cell lung cancer) the decision to release interim results was taken in response to threatened closure due to poor accrual, whereas in the GRIT trial (which compared two obstetric strategies for the delivery of growth retarded pre-term fetuses) the regular release of interim results was pre-planned. Nevertheless there are a number of common factors between these two trials. In particular, the trial treatments were already in wide use, with no reliable randomised evidence on which treatment should be used for which patients, and there was diverse clinical opinion, which meant that accrual was likely to be challenging. In a situation where a quarter to a third of trials do not accrue their required number of patients, the QUARTZ trial continues to accrue patients, and the GRIT trial successfully accrued its target of nearly 600 babies. Conclusions: This article therefore argues that there is a need to re-consider whether it is always essential to keep the interim results of randomized clinical trials confidential, and suggests some criteria that may help groups planning or running challenging trials decide whether releasing interim results would be a useful strategy. © 2014 The Authors.

Type: Article
Title: Interim results in clinical trials: Do we need to keep all interim randomised clinical trial results confidential?
Open access status: An open access version is available from UCL Discovery
DOI: 10.1016/j.lungcan.2014.05.012
Publisher version: http://dx.doi.org/10.1016/j.lungcan.2014.05.012
Additional information: © 2014 The Authors. Published by Elsevier Ireland Ltd. This is an open access article under the CCBY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/3.0/).
Keywords: Randomised clinical trials; Interim results; Whole brain radiotherapy; Non-small cell lung cancer; Growth restriction intervention; Evidence based medicine;
UCL classification: UCL
UCL > Provost and Vice Provost Offices
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Inst of Clinical Trials and Methodology
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Inst of Clinical Trials and Methodology > MRC Clinical Trials Unit at UCL
URI: https://discovery.ucl.ac.uk/id/eprint/1436504
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