Call for applications to lead an MRC-NIHR methodology state-of-the-art workshop on methods for placebo comparator group selection and use in surgical trials
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, MRC and NIHR are holding a series of Methodology State-of-the-Art Workshops (M-SAW) designed to achieve clarity around best practice in specific areas of biomedical/healthcare research 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, industry and internationally, bioethicists, 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 appropriate use of methods currently available for selecting and using appropriate placebo comparator groups in surgical trials. The publication should seek to explore the pros and cons of the various comparator group options, and to make clear recommendations on the circumstances in which each should, or should not, be used. Unmet methodological research needs may also be identified, as a secondary objective.
MRC and NIHR Boards and Panels are seeing an increasing number of applications for surgical trials, some with placebo procedures (or other comparator groups) and some without. The use of placebo procedures raises interesting methodological, ethical and consent questions around which there is uncertainty and lack of guidance, both in the research community and for the funders.
Guidance is needed to establish:
• When should placebo comparators be included, and if not used, what alternatives should be considered (and what potential comparator group options are available?)
• What are the merits and drawbacks of each?
• Design: How does the choice of comparator influence the design issues and challenges for trials in this field?
e.g. development of the placebo intervention (including standardisation), anaesthesia, the selection and design of co-interventions, blinding of patients and trial staff especially outcome assessors, etc.
• Protocol adherence: How does the choice of comparator influence how intervention fidelity might be achieved?
• Analysis: What the implications for analysis of trials?
• What are the bioethical issues for informed consent and recruitment?
For more detail on the challenges, prospective applicants are directed to a recent review of the feasibility of surgical randomised controlled trials with a placebo arm (1) and a review of the ethics of placebo-controlled trials: a comparison of inert and active placebo controls (2).
(1) Feasibility of surgical randomised controlled trials with a placebo arm: a systematic review. Wartolowska K, Collins GS, Hopewell S, Judge A, Dean BJ, Rombach I, Beard DJ, Carr AJ. BMJ Open. 2016 Mar 15;6(3):e010194.
(2) The ethics of placebo-controlled trials: a comparison of inert and active placebo controls. Edward SJ, Stevens AJ, Braunholtz DA, Lilford RJ, Swift T. World J Surg. 2005 May;29(5):610-4.
Applicants are invited to submit a maximum five-page proposal (10 point Verdana 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.
High level costings should be detailed in a table separate to the 5 page case for support. Indirect costs are not eligible.
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.