News

To take advantage of so many trial methodologists, trial managers, statisticians, data managers, trialists, chief investigators and others being in Brighton for ICTMC (https://ictmc2019.com), we’re going to hold a Trial Forge meeting on Sunday 6th October. This isn’t part of ICTMC so you don’t need to register for ICTMC to attend the Trial Forge meeting. That said, ICTMC is a fabulous conference so go if you can.

This will be the first of an ongoing series of free, open Trial Forge meetings intended to initiate, discuss and develop ideas for priority research work that aims to improve the evidence-base for trial process decision-making. The meeting will be a mix of plenary, participant-led discussion and small group work.

Email info@trialforge.org to say you’d like to come (and to get a coffee and a snack..)

The anticipated size of the meeting is around 50 participants mainly from the UK but with some international participation. The expected outputs are new, collaborative ideas for how to support evidence-based trial process decision-making in the UK and elsewhere. We anticipate that several new research initiatives will be launched at the meeting, with teams then looking for external funding where necessary. The meeting will also disseminate existing knowledge about effective and evidence-based trial process decision-making.

The agenda has yet to be drawn up but confirmed speakers include:

Matthias Briel, Switzerland: to discuss opportunities for collaborative work on recruitment projections and trial resource planning.

Declan Devane, Ireland: to discuss how Trial Forge can work with the Trial Methodology Research Network, Ireland.

Michelle Kho, Canada: to discuss work on SWATs planned in Canada.

Shaun Treweek, UK: to introduce Trial Forge and outline how we can all work together to improve trial efficiency.

See https://www.trialforge.org/tour-date/trial-forge-open-working-group-meeting/ for more details.

Given that hundreds of thousands of randomised trials have been done and tens of thousands are ongoing right now, you might think that there’d be plenty of research to support choices such as how best to recruit and retain participants, how best to collect data, or how to effectively disseminate the trial results. Sadly, you’d be wrong. There is remarkably little evidence available to support the doing of trials, and trials are much less efficient than they could be as a result.

This is what makes the UK National Institute for Health Research’s (NIHR) new funding stream for ‘Studies Within A Trial (SWATs)’ in the Health Technology Assessment (HTA) program such great news. This new scheme makes it possible to build a SWAT costing up to £10,000 into every HTA trial, with the approval process for this being light-touch.

A good starting point for selecting a SWAT is the SWAT repository, which provides outlines for more than 50 existing SWATs. What would help even more is if SWATs are coordinated, so that we get evidence from several evaluations quickly. This body of evidence can then be used to inform trial process decisions and researchers can move on to other SWATs, rather than have single SWAT evaluations floating around for years but unable to really help decision making. Trial Forge can help with this (contact us at info@trialforge.org) as can York Trials Unit, which has built up a lot of SWAT expertise over the years (contact Adwoa Parker at adwoa.parker@york.ac.uk). York also has a useful page on SWATs.

See also:

Trial Forge SWAT Guidance.
PRioRiTy Top 10 unanswered recruitment research questions
The 2018 update of the Cochrane recruitment review.

Randomised trials are a central component of all evidence-informed health care systems and the evidence coming from them helps to support health care users, health professionals and others to make more informed decisions about treatment. The evidence available to trialists to support decisions on design, conduct and reporting of randomised trials is, however, sparse.

One way to fill gaps in evidence is to run Studies Within A Trial, or SWATs. This first piece of Trial Forge guidance provides a brief definition of SWATs, an explanation of why they are important and some practical ‘top tips’ that come from existing experience of doing SWATs. By coordinating evaluation of the same SWAT in several trials, we can reduce uncertainty about intervention effects much faster.

We hope the guidance will be useful to trialists, methodologists, funders, approvals agencies and others in making clear what a SWAT is, as well as what is involved in doing one.

The guidance is published in Trials at https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-018-2535-5

How Do We Know If A Site Is Performing Well?
Julie Turzanski, Diane Whitham and Leila Duley at the Nottingham Clinical Trials Unit are leading a project to improve trial efficiency by agreeing a standardised set of metrics for monitoring site performance.

The project is now running an online Delphi survey as part of work to agree a core set of metrics that are essential for the management, reporting and tracking of site performance in multicentre trials. The idea is that this will serve as an ‘at a glance early warning system’, allowing potential problems at a site to be addressed before a trial is affected adversely.

You can start the survey by clicking:

https://ctrc.liv.ac.uk/DelphiManager/ClinicalTrialMetrics

The survey is expected to run for up to three rounds, sent out in June, July and August 2017 and each round should take approximately 15 minutes to complete. The first round will run until June 23rd.

Participants completing all three rounds will be entered into a prize draw for the chance to win:

BOSE QuietComfort® 35 Wireless Headphones (first prize)
£100 Amazon.co.uk Gift Voucher (2 prizes)
£50 Amazon.co.uk Gift Voucher (2 prizes)
If you would like more information, please email Julie.turzanski@nottingham.ac.uk.

How Do We Know If A Site Is Performing Well?
We are all interested in trial site performance. Julie Turzanski, Diane Whitham and Leila Duley at the Nottingham Clinical Trials Unit are leading a project to improve trial efficiency by agreeing a standardised set of metrics for monitoring site performance. The project will also create a tool for presenting the metrics to trial mangers, Trial Management Groups and Trial Steering Committees.

Clearly this needs agreement as to what metrics are important. The starting point will be the literature, followed by focus groups and a Delphi survey and will end with a consensus meeting.

The project team would also like to invite two experienced trial managers to assist with the project, particularly linked to designing the Delphi survey and sharing their expertise. If you would be interested please email Julie.turzanski@nottingham.ac.uk with a brief outline of your suitability. The closing date for expressions of interest is 26th Oct 2016. A project outline is available here.

Contact: Julie.turzanski@nottingham.ac.uk