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Retention in trials: a theory-based cover letter

Retention Is In The Top 3 Of Trialists’ Worries.
We’re running an evaluation of a theory-based cover letter that is sent together with your questionnaire(s) that are being used to collect trial outcome data at the moment. It’s a simple and cheap intervention and has shown benefit in an earlier trial. There’s a template to prepare the letter, which is very straightforward to use.

What we want to do now is test it in a wider range of trials and participant groups and collate the results through Trial Forge. The results would then go into the Cochrane review of interventions to improve recruitment (http://bit.ly/1Q7NPuA).

The registration is on the SWAT database (http://bit.ly/20ZqazA).

Trial Forge also has a bundle of extra materials that we can send groups interested in using the intervention. The extra information includes text that you could put into an ethics submission, or a grant proposal.

Get in touch if you’d like more information.

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Trial Forge PhD opportunity

Trial Forge currently has a PhD opportunity, the topic of which will depend on the skills and interests of the student. Topics that could be covered include:

developing effective participant recruitment strategies;
effective training of trial staff;
improving retention of trial participants;
reducing the burden of data collection;
reducing the impact of protocol changes; and,
auto-updating of systematic reviews.
More details are at https://www.abdn.ac.uk/clsm/graduate/research/trial-forge-1207.php

Deadline is 25th March 2016.

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Trial Forge at the 2015 REWARD/EQUATOR Conference

An estimated 85% of research is wasted; this is usually a result of asking the wrong research questions, flawed methodology, lack of publication or poor reporting. This not only diminishes the value of research but causes substantial financial loss. Many of the reasons for research waste are simple issues that we can solve; examples include appropriate randomisation, blinding where possible and working together to design trials effectively and efficiently.

Groups and collaborators across academia are making a concerted effort to reduce research waste; the REWARD campaign and the EQUATOR Network are two examples. This year REWARD has partnered with the EQUATOR Network to host the REWARD/EQUATOR conference.

The REWARD (REduce research Waste And Reward Diligence) campaign is an extension of The Lancet’s 2014 series on Research: increasing value, reducing waste; you can view this series online here: Link to The Lancet Series. Progress since the publication of this series will be celebrated, and an action plan for the future will be developed at the conference. Trial Forge is a supporting partner of the REWARD campaign.

The EQUATOR (Enhancing the QUAlity and Transparency Of health Research) Network is an international initiative that seeks to improve the reliability and value of published health research literature by promoting transparent and accurate reporting and wider use of reporting guidelines. The network has centers across the UK, France, and Canada and has worked to produce reporting guidelines covering randomized trials, observational studies, systematic reviews, and much more.

The conference, taking place between 28th and 30th September 2015 in Edinburgh, Scotland, will focus on combining the themes and values of EQUATOR and REWARD to review the progress made by researchers, funders, and other stakeholders in increasing value and reducing waste in biomedical research. The conference will also play host to numerous speakers and presentations allowing attendees to understand what they can do to alleviate waste within their research fields going forward.

Trial Forge founder Professor Shaun Treweek will be attending the conference and has been asked to give two presentations.

The first takes place on Tuesday, 29th September as part of the ‘Researchers and Regulators’ Stakeholder Plenary and will give a broad introduction to the Trial Forge project as a whole, what we hope to achieve through the work of Trial Forge, and ways to work with us to make trials more efficient. The second will be in the ‘Top scoring submissions’ session on Wednesday, 30th September, where Shaun will focus on reducing waste through better trial design; emphasizing the use of the PRECIS-2 tool.

If you can’t make the conference and would like to know more about Trial Forge, the video below is a great starting point.

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Trial Forge: A Systematic Approach to Making Trials More Efficient

Randomised controlled trials (RCTs) are at the core of evidence-based healthcare; they offer the fairest way of evaluating healthcare interventions, whether these interventions include medicinal products, devices or services. Thousands of RCTs are completed across the world every year, providing us with evidence that allows us to draw conclusions on how we manage and treat human disease. What is so surprising though is the level of inefficiency that riddles the design and execution of trial processes.

RCTs are not cheap – the average cost of a trial is estimated to be ~£8,500 per participant in the United Kingdom (1), and with thousands beginning each year the slightest delay or problem can impact budgets immensely. Recruitment of participants is a vital component of the trial process, but high-quality evidence to support strategic approaches to recruitment is thin on the ground; largely we rely on anecdotal information from the trial management team. Recent analysis of trials funded by the UK National Institute of Health Research (NIHR) and Medical Research Council (MRC); the cream of the crop in terms of UK public health trials, highlighted that only 55% of trials recruiting between 2002 and 2008 met their recruitment targets, 45% of these trials required at least one funding extension and even then, only 55% of that group went on to meet their recruitment targets (2). It’s important to highlight that the 55% of trials that received no funding extension were still permitted additional time; the cost of time consists of overheads for the sites involved, staff costs and opportunity lost costs – so no extension is entirely free.

Patient recruitment is just one of the key processes that have been identified as open to inefficiency; others include patient retention, staff training, data management and dissemination, and trial closedown. Trial Forge ultimately aims to work across all trial processes.

Perhaps most importantly, the project aims to create a ‘go to’ website which will efficiently collate evidence on various aspects of trial methodology. There are thousands of papers published every day, meaning it’s very easy for us to lose information in the mass of individual publications; the gathering of data into one user-friendly place will allow us to ascertain what we actually know about trials. Once we know what we know, Trial Forge will be able to clearly identify what we don’t know; drawing attention to areas of methodology research which lack cohesive study, and acting as a support hub for trialists who are looking to address this lack of evidence.

Trial Forge’s first meeting back in July 2014 included prominent members of the trial methodology community, and produced widespread enthusiasm for the potential impact that the platform could have on the way we design, run and report trials.

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