Systematic Techniques for Assessing Recruitment to Trials (START): a programme to test recruitment interventions

Lead Research Organisation: University of Manchester
Department Name: Medical and Human Sciences


The best way to test new treatments is to see how well they work in a randomised controlled trial (RCT). This means some patients get the treatment and some do not, and the results of the different groups are compared to see if the treatment leads to better health. Although many trials like this are run in the NHS, recruiting patients to these trials is often difficult and takes longer than planned. This means that research is delayed and that patients and professionals cannot benefit from the knowledge about what treatments work best.

Our aim is to develop new ways of helping to recruit patients to trials, and to test them in randomised controlled trials that are ongoing in the NHS.

To achieve this, we will do three things:

(a) We will develop methods to help us test recruitment methods, by looking at the published work worldwide and exploring different statistical issues

(b) We will develop new methods to help patients take part in trials, such as new ways of providing information to patients to help them understand randomised controlled trials

(c) We will work with researchers who are running trials in primary care and community settings, helping them to use our new patient information with their patients. We will collect data from these trials and test whether our new methods improve recruitment rates

As well as testing our new methods, we hope our work will help us to understand how best to test recruitment methods in trials, and will encourage researchers in the future to get involved in such testing. This will help the NHS to do research and use the knowledge to improve the health and well being of patients.

Technical Summary

Our aim is to improve the evidence-base concerning recruitment to trials, enhance recruitment rates and make research more accessible to the public.

Randomised controlled trials (RCTs) are critical to evidence-based practice, but recruitment is often problematic, with little rigorous evidence to assist research teams in recruitment and retention of participants. Without the development of reliable methods, the policy goal of improving health and wealth through research will be hard to realise.

A robust test of the effectiveness of a recruitment method is an RCT comparing one method with an alternative, nested in a host trial. Such nested studies are rare, largely delivered in an ad hoc way, and always tested in the context of a single host trial, limiting their utility

Our vision is to develop a methodology to develop, deploy and test recruitment interventions nested within ongoing host RCTs, to rapidly and systematically improve the evidence base. To achieve this, we propose a programme of three interrelated work packages:

(a) Methodology ? We will develop methods for design and analysis of nested recruitment studies

(b) Interventions ? We will develop recruitment interventions

(c) Implementation ? We will recruit a cohort of host RCTs and test our recruitment interventions through nested studies across multiple trials


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