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Table 1 Issues in promoting rapid research by stage of research

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

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