Clinical trials methodology research and the Global Health Working Group of the Trials Methodology Research Partnership (TMRP)

Clinical trials are still a relatively new concept, with the first modern randomised controlled trial (RCT) only conducted in 1948. For many subsequent years there was little progress in terms of novel ways to design, conduct, manage, analyse and report trials despite significant changes in, for instance, medicine, health care technology, and our understandings of ethics. However, obtaining good quality evidence for cost-effective healthcare interventions that satisfies payers, prescribers and users is more important than ever.

This means that the methods we use in clinical trials should continually be questioned so that they are optimal and responsive for a broad range of stakeholders. As such, the past decade has seen a new field of clinical trials methodology research – research about the way we conduct trials and other types of clinical research.

The above issues are important for wherever trials are conducted, including in low- and middle-income countries (LMICs), as it cannot be assumed that the same methods will be important, relevant or acceptable in every context. As such, the Global Health Network is delighted to join a new MRC-NIHR Trials Methodology Research Partnership (TMRP), from June 2019, so that researchers in low resourced settings may both benefit from and contribute to ongoing developments in clinical trial methodology research. These developments will increase the ability of trials methodologists in the UK and other higher income settings to work with partners in LMICs to address key priorities and capture novel approaches successfully implemented in LMICs, thereby adding a global health voice to the overall effort of the partnership.

To ensure that the voice of those working in LMICs is heard, the Global Health Network will work closely with a new Global Health Working Group of the TMRP. Objectives are to:

1) Raise awareness of the field and scope of clinical trial methodology research to those in LMICs

2) Signpost them to the other Working Groups of the TMRP (Stratified Medicine, Health Informatics, Adaptive Designs, Outcomes, Trial Conduct, Health Economics, and Statistical Analysis)

3) Further increase the capacity for trial methodology research in LMICs through freely accessible information on this dedicated site

4) Respond to queries from those in LMICs wanting guidance on methods, potential collaborators and training opportunities/events

5) Manage small pump-priming grants for LMIC clinical trials methodology research projects

Priority areas of trials methodology research have been identified from a LMIC survey by Rosala-Hallas et al 2018 in collaboration with the Global Health Network, including: appropriate choice of outcomes (developing correct objectives, standardising outcome sets, identifying patient-focused endpoints) and methods for staff training (e.g. cost-effective and purposeful methods, blended learning incorporating new technologies).

Please keep an eye on this page for updates as this new partnership is rolled out and follow us on Twitter @GHWG_TMRP