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3.6 Advisory and Governance Functions

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It is usually helpful to establish an advisory group during the planning stage, as having a strong advisory group that endorses the IPD meta‐analysis project may add to credibility, be helpful in persuading trial investigators to participate, and strengthen funding applications.

As well as providing independent advice, an advisory group can play an important role in garnering wider clinical or topic expertise, and providing additional methodological oversight. It is also a good way to engage patients and the public in a meaningful way, ensuring that the patient voice is heard. Therefore, an advisory group will often include members from different specialties and professions that are relevant to the review topic, representation from patient support groups, individual patients and carers (who will often have a different perspective to support groups), and methodologists. For example, the advisory group for an IPD meta‐analysis project (and linked economic evaluation) examining intensive behavioural interventions based on applied behaviour analysis (ABA) for young children with autism included: representation from the National Autistic Society, research study investigators, parents of children with autistic spectrum disorder, adults with autism spectrum disorder, ABA practice specialists, psychiatrists, clinical and educational psychologists, specialists in IPD meta‐analysis, and health economists.78 Having well‐respected international members of the advisory group might be particularly helpful when requesting IPD from trial investigators working in different countries to the central research team.

As participant‐level data are being used, commissioners may sometimes suggest that an IPD meta‐analysis project should establish governance structures similar to those for a clinical trial. However, with the exception of those that are prospective (Section 3.12), IPD meta‐analysis projects use participant‐level data that have already been collected in existing trials and no new participants are being recruited; therefore, there should usually be no requirement for a steering or data monitoring and ethics committee (as would be needed for a clinical trial).

Individual Participant Data Meta-Analysis

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