News

The STRIDE project has come up with eight recommendations for trial teams grappling with how to decide which ethnic groups their trial needs. The recommendations came as a result of discussions with panels of public contributors, trialists, health professionals, and others.

Some of the key messages include the fact that decisions need to be made by the trial team together with people from diverse ethnic communities with lived experience of the disease or condition, as well as professionals with experience of treating the disease or condition. When a trial team cannot reach a conclusion regarding the ethnic groups needed, STRIDE suggests including ethnic groups in at least the same proportion found among the population of people with the condition targeted by the trial. And where these data do not exist or cannot be obtained, include ethnic groups at the same proportion as is found in the most recent census data. Additionally, trial sites need to be placed as close to the places where people in the needed ethnic groups live.

For more information and to access the full recommendations, please visit: Link to the full article

This is only v1.0 of the recommendations, and feedback is welcome. If you’d like to provide comments or feedback, please contact them at info@trialforge.org.

The Trial Steering Committees can seem a bit daunting, but the Trial Methodology Research Network (TMRN) in Ireland is running a 1-day online workshop on 15th May 2023 on what to expect on a Trial Steering Committee. The workshop faculty is superb and will give researcher, public, governance, and funder perspectives on Trial Steering Committees.

You can download the program at the link below and register for the workshop at Eventbrite registration link.

For more details and the program, please follow this link: [TMRN Trial Steering Committee Workshop Program 15th May 2023](link to the program).

In 2022 we published an article called ‘Getting it wrong most of the time? Comparing trialists’ choice of primary outcome with what patients and health professionals want‘. It looked at the outcomes selected in 44 breast cancer and kidney trials and asked patients and health professionals how they would rank those outcomes in terms of importance. We were particularly interested in the most important – the primary outcome. In summary, from the perspective of patients and health professionals, trial teams chose the wrong primary outcome 72% of the time.

A public contributor on twitter asked if any of the 44 trials involved patients and publics in selecting their outcomes. Perhaps those that did were more likely to have a primary outcome that matched what patients and health professionals wanted?

It was a good idea and an article written together with the public contributor who suggested the study has just been published. In summary, none one of the 44 trial teams involved patients and the public in choosing outcomes.

Plenty of room to do better in other words.

Can you help with the development of the INCLUDE Impaired Capacity to Consent Framework by piloting the framework and sharing feedback about how it can be used in practice?

Trials involving adults who lack capacity to consent can be challenging. Following on from the NIHR INCLUDE guidance to improve the inclusion of under-served groups in research, and the development of the Ethnicity Framework, members of the inclusivity sub-group of the Trial Methodology Research Partnership (TMRP) Trial Conduct Working Group are now leading the development of a framework to help researchers to design trials to be inclusive of adults with impaired capacity to consent.

We are asking researchers involved in the design and conduct of trials which may include adults with impaired capacity to consent to pilot the framework using a research proposal (this could be a real or hypothetical trial) and provide feedback. You can contribute as an individual or within a small team, and the activity is anticipated to take 2-3 hours. With your permission, your contribution will be acknowledged by name in the framework documents.

The journal Research Methods in Medicine & Health Sciences is running a special issue addressing Studies Within A Trial (SWATs) (guest editors Professor Mike Clarke and Dr Adwoa Parker).

The aim of this special issue is to promote the use of SWATs and to report key methodological advances. The journal is inviting submissions from researchers for completed SWATs and SWAT methodology (both quantitative and qualitative). There will be no article processing fees for authors, and articles will be free to access.

The deadline for submission is October 30th, using the following link: Link to Submission. In your cover letter, please state that you are submitting to the SWATs special issue.

A SWAT Reporting Guidelines Template is currently being piloted, and authors are welcome to use it to report their SWATs. This is available at: SWAT Reporting Guidelines Template (scroll down). To provide feedback on the SWAT Reporting Guidelines Template, please email: prometheus-group@york.ac.uk

For any correspondence, queries, or additional requests for information on the manuscript submission process, please contact:

Joel Gagnier, Editor-in-Chief: jgagnier@umich.edu
Mike Clarke, Guest Editor (SWATs): m.clarke@qub.ac.uk
Adwoa Parker, Editorial Board Member (SWATs): adwoa.parker@york.ac.uk”
If you need further details or have any questions, please let me know.