News

One way to fill gaps in trial process evidence is to run Studies Within A Trial, or SWATs. A while ago, the Health Research Board–Trial Methodology Research Network in Ireland together with Trial Forge produced a 2-page summary of the SWAT guidance that we published in Trials (see Trial Forge SWAT guidance).

The 2-page summary is now also available in German, have a look at this document in German.

Vielen Dank to Susanne Döpfmer, at the Institute of General Practice, Charité – Universitätsmedizin Berlin, for doing the translation.

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. At some point, increasing SWAT evidence will lead funders and trialists to ask: given the current body of evidence for a SWAT, do we need a further evaluation in another host trial? This new Trial Forge guidance provides a set of criteria for answering this question. The intention is to avoid SWATs themselves contributing to research waste

We hope the guidance will be useful to trialists, methodologists, funders, approvals agencies and others in making clear when a new evaluation of a SWAT intervention is needed and, importantly, when it is no longer a priority.

The guidance is published in Trials (https://doi.org/10.1186/s13063-019-3980-5) and is also part of the SWAT guidance package on the National Institute for Health Research (NIHR) website (https://www.nihr.ac.uk/documents/studies-within-a-trial-swat/21512).

ESP2 is now live! See https://w3.abdn.ac.uk/hsru/ESP2/

ESP2 asks the people who set up new trial recruitment sites to use an 8-item checklist to give their predictions of trial site recruitment at the site. We need 1000 site recruitment predictions and it would be fantastic if you and your colleagues could get involved. Everything is done online through the ESP2 website.

Trial Forge has teamed up with the UK Trial Managers’ Network (UKTMN) to do ESP2, which is the much bigger follow-on study to the original ESP project published in the journal Trials. The new guided prediction form from the first project is at the heart of ESP2.

See the ESP2 website for more details and the resources below.

Resources

Key facts slides set as Powerpoint and pdf.
A5 flyer on ESP2.

A Trial Forge recruitment project called Estimating Site Performance (ESP) has just been published in the journal Trials. The study asked trial managers at the Centre for Healthcare Randomised Trials (CHaRT), University of Aberdeen, to predict whether a site would recruit to target. No guidance was given as what trial managers should consider when making this judgement.

Ten trial managers made predictions for 56 site visits recruiting to eight trials. Trial managers correctly identified 65% of sites that would hit their recruitment target and 54% of those that did not. Eight ‘red flags’ for recruitment failure were identified: previous poor site performance; slow approvals process; strong staff/patient preferences; the site recruitment target; the trial protocol and its implementation at the site; lack of staff engagement; lack of research experience among site staff; and busy site staff. These red flags to develop a guided prediction form.

The new guided prediction form will be used in a new, much larger follow-on project: ESP2. We’ll need 1000 recruitment predictions in ESP2 so if youiare interested in helping, get in touch at info@trialforge.org.

The full article is at https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-019-3287-6.

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.