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Ethical and regulatory considerations in the use of individual participant data for studies of disease prediction
  1. Bob Phillips,
  2. Neil Ranasinghe,
  3. Lesley A Stewart,
  4. on behalf of the PICNICC Collaboration
  1. Centre for Reviews and Dissemination, University of York, York, UK
  1. Correspondence to Dr Bob Phillips, Centre for Reviews and Dissemination, University of York, York YO10 5DD, UK; bob.phillips{at}york.ac.uk

https://doi.org/10.1136/archdischild-2013-304149

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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, …

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    Footnotes

    • Contributors BP co-conceived the project, designed the survey methods, collated and synthesised the results, and drafted the report. NR contributed to the development of the ideas and writing the study report. LAS co-conceived the project, reviewed the results and revised the report. The other members of the collaborative (see below) have shared their experiences, read and reviewed the paper and contributed to the discussion of ethical concepts underlying the report.

    • Collaborators The PICNICC collaboration is formed by those who have contributed data, or for patient/carer partners, significantly developed the project. The members are currently: authors, Roland A Ammann, Thomas Kuehne, Felix Niggli and David Nadal (Switzerland), Ian Hann (Ireland), Lillian Sung, Robert Klaassen and Sarah Alexander (Canada), Thomas Lehrnbecher and Arne Simon (Germany), Karin Meidema and Wim JE Tissing (Netherlands), Alex J Sutton, Richard Riley, Julia Chisholm and Rachel Dommett (GB), Elio Castagnola (Italy), Pamela Silva and Juan Tordecilla (Chile), Maria Spassova (Bulgaria), Hana Hakim and Glen Stryjewski (US), Gulsun Tezcan (Turkey), Lidija Kitanovski (Slovenia), Tiene Bauters and Geneviève Laureys (Belgium), Marianne Paesmann and J Peter Donnelly (EORTC).

    • Funding Grant number is MRC Research Training Fellowship G0800472.

    • Competing interests None.

    • Provenance and peer review Not commissioned; internally peer reviewed.