From: Rapid, responsive, relevant (R3) research: a call for a rapid learning health research enterprise
Concept through trial preparation | Recruitment through follow-up | Analysis through publication | |
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Stakeholder Relevance | • Engage stakeholders via evaluability assessment to assist with design of practical trials • Consider outcomes and measures important and relevant to stakeholders who will need to act on results • Establish stakeholder “citizen-scientist” feedback panels; leverage networking technologies. | • Ongoing engagement with stakeholders on methods to improve recruitment and follow-up retention • Submit preliminary findings to stakeholders for review and direction-setting | • Submit initial results to stakeholders for assistance with interpretation, relevance, dissemination and forming next study questions • Share presentations with stakeholders at policy and practice venues |
Design Issues | • Replace the traditional pilot with iterative N-of-1 and optimization designs | • Consider within-subject and MINC to typical comparison conditions • Leverage technology to automate RCTs when possible • Consider alternatives to the two-arm RCT including factorial, within subject, pragmatic, quasi-experimental, and rapid learning designs | • Report proximal outcomes while follow-up data collection continues |
Review Issues | • Streamlined grant review process • Encourage reviewers to consider innovative designs that speed research • Streamline IRB approval process, especially for low risk studies | • Rapid modification approvals from IRBs | • Encourage online and open access publication • Incentives to speed manuscript reviews |
Infrastructure Issues | • Use of data standards and common data elements to improve research efficiency and facilitate data sharing • Create rapid learning systems that can generate data to test multiple competing hypotheses and develop predictive models • Create national biobank/bio-samples systems | • Use practice network registries to speed recruitment, provide enriched histories & follow-ons • Leverage existing EHR and other rapid learning data systems to rapidly test hypotheses | • Robust policies and procedures for data sharing and merging • Improved systems for disseminating findings to appropriate stakeholders |