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Cardiff University research seeks to help address gaps in methodology across clinical trials worldwide

20 December 2017

People in a meeting

Background

The Study Within a Trial (SWAT) programme was created to address methodological gaps in the way trials are conducted: specifically, the way trials are conducted is not always based on evidence. A SWAT is a study which aims to understand what works best in running trials.

One example is SWAT 17 that looks at evaluating the effects on recruitment of following up initial participant invitation letters with a letter or a telephone call (Lesley Anderson and Glen Titmarsh, January 1 2012 - 1547). Researchers with an idea for a SWAT can upload a study protocol to the SWAT Store, an online repository which can be accessed by all, and other trialists can take the protocol and implement it in their current clinical trials. In this way, the same research question can be asked across several trials, so providing an increased sample size and enhanced generalisability.

SWAT 66

Along with colleagues Professor Kerry Hood and Dr Mark Kelson, Claire Nollett recently published to the SWAT Repository Store SWAT 66 entitled ‘Site visits to initiate recruitment in a clinical trial: Does it matter who conducts the visit?’. This is a follow on from the first SWAT published and examines whether it is important who makes a site visit to encourage a site to start recruitment.

It is common for trial managers to experience trials in which a site has been initiated but hasn’t started recruitment; in some circumstances trial managers may pay them a visit to find out why and how to get them started. Claire and fellow researchers are interested to know if it makes a difference to successful study step up depending on whether the sites are visited by a member of the research team or a clinical peer eg. GP to GP.

Clinical trials exist to provide gold standard evidence about health care. However, the way trials themselves are designed and managed is not always based on evidence. Using a SWAT, we evaluate whether sending a researcher or clinician is most useful by collecting data across trials.

Dr Claire Nollett Research Design and Conduct Service Consultant, Research Fellow and Academic Lead for Public Involvement and Engagement

Get involved

Any trial facing this problem can implement our SWAT protocol and contribute the findings to the SWAT team, thus helping to provide an evidence base for ways to improve recruitment across trials.

A full article about the SWAT has also been published in the Journal of Evidence Based Medicine.

For further information please contact Claire Nollett at nollettcl@Cardiff.ac.uk

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