MRC-NIHR Methodology State-of-the-Art Workshop: complex risk-benefit analysis
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Call for applications to lead an MRC-NIHR Methodology State-of-the-Art Workshop on complex risk-benefit analysis by question class, between non-inferiority and superiority designs
There is a translational gap in moving novel medical/healthcare research methodologies from creation and early testing through to widespread acceptance, uptake and routine usage, and a challenge in understanding best practice, particularly in fields with multiple competing methodologies and uncertainty/lack of consensus around which method is most appropriate in which circumstance.
To address this, the MRC and National Institute for Health Research (NIHR) are holding a series of Methodology State-of-the-Art Workshops (M-SAW) designed to achieve clarity around best practice in methodology, and to provide guidance to the community.
Applications are invited from teams wishing to scope, design and lead an MRC-NIHR branded workshop on this topic which would inform the writing and publication of a framework/guidance paper or state-of-the-art report, led by the organising group.
MRC-NIHR branding of the finished document will be subject to final approval by funders. No other restrictions to publication will apply beyond standard MRC terms and conditions.
A budget of up to £50,000 is available to fund the successful applicant team to:
- Conduct a background review, setting the scope of the workshop
- Secure workshop invitees and speakers (UK academia, regulators, health policy decision makers, industry and internationally, as appropriate)
- Fund venue hire and participant travel, accommodation and subsistence expenses
- Write guidance/consensus paper/framework/state-of-the-art report, based on workshop proceedings
The primary function of the publication should be to summarise the state-of-the-art, and to provide guidance to the community on the optimal design to inform risk-benefit analyses within different-in-kind comparisons.
The publication should be suitable to inform the decision analysis process within study design, and to directly consider the needs of HTA and/or NHS decision makers.
- Define limits for when non-inferiority and superiority designs are and are not appropriate
- Set out the pros and cons of approaches to risk-benefit comparisons presented by question class
- Make clear recommendations, illustrated by case studies, for the optimal approach within each class
As a minimum, guidance must consider requirements for clinical trial design, but extension to include broader needs of health services and delivery research may be considered in response to initial scoping work or at the applicants’ discretion.
Unmet methodological research needs may also be identified, as a secondary objective.
Draft guidance should be delivered within 18 months from issue of the award.
MRC and NIHR Boards and Panels increasingly see application of standard non-inferiority trial designs to different-in-kind comparisons. In this context, trials powered to examine efficacy, are often inappropriately extended to draw conclusions pertaining to health economics or risk exposure. It is therefore apparent that uncertainty exists regarding optimal design for risk-benefit analyses that extend beyond primary endpoints.
Guidance is therefore required to:
- Establish classification of target comparisons
- Conceptualise these comparisons within a research plan
- Provide a decision-making framework to inform the optimal formal test for comparison class
Within this call, optimal designs should be defined in response to the evidence needs of HTA and/or NHS commissioners. Each classification should be illustrated by a suitable case study.
Applicants should submit a case for support proposal (a maximum of 5 sides of A4; 10 point Arial font) covering:
- Relevance of expertise of the team of applicants
- Proposed background research
- Proposed scope and format of the workshop
- Methodology for identifying participants, eliciting views and translation of workshop proceedings into guidance
- Format of the proposed publication and publication/dissemination strategy
- The proposed project timeline
- Alongside the proposal, CVs for all applicants should be submitted.
Please detail high-level costings in a table separate to the 5-page case for support. Indirect costs are not eligible.
A maximum of one application will be funded in response to this call. All applications will be considered in open competition by the MRP Advisory Group on 11 July 2018.
Any questions or queries should be submitted to Dr Samuel Rowley, MRC Programme Manager for Methodology and Clinical Research.
Applications should be submitted to Dr Samuel Rowley before the deadline.