Research methodology workshop: maximising information from empirical studies
23 January 2017, 10.00 to 16.00
The Tomlinson Centre, Hackney, London E8 3ND
 
Event is free but places are limited, so registration is essential. To register, please email Chris Newby: [log in to unmask]  
 
This event is organised by the Methodology Group within the national Asthma UK-funded Centre for Applied Research (http://www.aukcar.ac.uk/ ) and is open to anyone interested in the topics that will be covered. There will be five invited talks (see below) and two break-out discussion sessions – one on data sharing, the other on maximising uses of economic data.
 
 
Introduction
In recent years there has been growing interest in maximising research efficiency. One way of doing this is to ensure that we maximise the amount of useful information we can obtain from empirical studies. Various ideas have emerged e.g. data sharing, undertaking embedded studies within trials, coordinating work on trying to make trials more efficient, using common outcomes across studies, re-using randomised data to answer new questions.  In this workshop we will discuss how some of these ideas might work. 
 
Aims of the workshop
 
  *   Hear about a number of specific ideas for maximising research output
  *   Provide an opportunity to interact and share ideas for maximising output from asthma research
  *   Generate ideas for moving forward in developing methodology in this area
 
Invited talks/speakers:
 
Trial Forge (Heidi Gardner, Aberdeen)
RCTs are at the core of evidence-based healthcare. They guard against selection bias and therefore offer the fairest way of evaluating healthcare interventions, whether these involve medicinal products, devices or services. Thousands of RCTs are completed across the world every year, providing researchers with evidence that allows policy makers, clinicians and healthcare professionals to draw conclusions on how to manage and treat human disease. What is surprising, however, is the lack of evidence and high level of inefficiency that riddles the design and execution of trial processes. Trial Forge aims to change this. Trial Forge is a collaborative project that will support both the dissemination of what we do know about effective ways to design, run, analyse and report trials, and the generation of research evidence to plug gaps in the evidence base to support trial decisions. Collaboration doesn’t just mean trialists; it means people working across both industry and academia, the public, patients, healthcare professionals, funders, approvals bodies and others. Inefficiency within clinical trials has been a problem for a long time, it’s time for a new approach.
 
Data sharing (Catrin Tudur-Smith, Liverpool)
Sharing Individual Participant Data (IPD) from completed clinical trials offers numerous well recognised advantages that can advance clinical research and benefit patients. The clinical trial community, including publicly funded trials, has a duty to facilitate this process. In our recent survey [1], publicly funded clinical trials units (CTUs) from the UKCRC registered CTUs network were supportive of the principle of sharing IPD. However, concerns were also raised including complex and varied sponsorship arrangements of the trials they coordinate, inappropriate reuse of clinical trial data, additional resource required for CTUs to prepare and share data, potential loss of ability to publish further research, and the potential risk to trial participant privacy. The CTUs preferred the use of a controlled access approach, with systems in place to review data access requests from researchers. We have used the results of this survey, input from an expert committee and an open consultation involving the UKCRC registered CTUs to inform the development of guidance summarising good practice principles for sharing IPD and associated documentation from publicly-funded clinical trials [2]. In this talk I will draw upon personal experiences of accessing and using IPD and will discuss the advantages, alternative models for sharing IPD, how the landscape of clinical trial data sharing is changing, and how more could be done to facilitate the responsible sharing of IPD.
[1] Hopkins C, Sydes M, Murray G, Woolfall K, Clarke M, Williamson P,  Tudur Smith C. UK publicly funded Clinical Trials Units supported a controlled access approach to share individual participant data but highlighted concerns. J Clin Epidemiol. 2016 Feb;70:17-25.
 
A funder’s perspective: MRC/NIHR Methodology Research Programme: funding opportunities (Peter Brocklehurst, UCL)
Peter Brocklehurst is Chair of the Methodology Research Programme panel. He will discuss the working of the panel, particularly in relation to (i) what methodology research the panel currently funds, (ii) the relationship between the Methodology Advisory Group and the highlight notices, (iii) areas of research that the panel is keen to see applications for, (iv) the process by which panel makes decisions about prioritising the applications, (v) tips for successful applications.
 
Short-cuts to randomised evidence (Seif Shaheen, QMUL)
Setting up de novo trials is expensive and time-consuming. A cheaper, more efficient and underused approach is to follow-up existing trial cohorts to collect new outcomes of interest. Seif will discuss examples of trials of early life interventions which were undertaken with a particular outcome in mind, but which provided opportunities to measure different (respiratory) outcomes in childhood.
 
SWAT (Studies Within A Trial) and SWAR (Studies Within A Review) programme (Helen McAneney, Queen’s University Belfast) 
In trying to find out what works, researchers face many uncertainties about the best methods for their trials, evidence syntheses and other evaluations. Embedded methodology studies can help. However, despite hundreds of thousands of trials and tens of thousands of systematic reviews, only a few hundred studies have assessed the effects of different methods for doing this research. SWAT (Studies Within A Trial) and SWAR (Studies Within A Review) are seeking to change this, by increasing awareness of research into research, stimulating interest in the need for it, inspiring new ideas, and improving access to the findings (go.qub.ac.uk/SWAT-SWAR). The programme was established by the Northern Ireland Hub for Trials Methodology Research, with funding from the Medical Research Council’s Network of Hubs in the UK. Each SWAT / SWAR outline comprises a simple, one or two page design. As of April 2016, more than 40 outlines have been registered. This presentation will describe the concept and present the template for the outline, which includes the background, intervention and comparator, method of allocation, primary outcomes, secondary outcomes, analysis, possible problems, likely costs, publications, and version information. Examples of ongoing and completed SWATs and SWARs will be shown. The presentation should stimulate ideas for future studies, and encourage researchers to see how they might maximize the impact of embedding research into research, to find out what works when conducting future trials, reviews and other evaluations; and, thereby, achieve the ultimate aim of knowing what works for better policies, programmes and practice.

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