Abstract
BackgroundRandomised clinical trials are the ‘gold standard’ for evaluating the effectiveness of healthcare interventions. However, successful recruitment of participants remains a key challenge for many trialists. In this paper, we present a conceptual framework for creating a digital, population-based database for the recruitment of asthma patients into future asthma trials in the UK. Having set up the database, the goal is to then make it available to support investigators planning asthma clinical trials.MethodsThe UK Database of Asthma Research Volunteers will comprise a web-based front-end that interactively allows participant registration, and a back-end that houses the database containing participants’ key relevant data. The database will be hosted and maintained at a secure server at the Asthma UK Centre for Applied Research based at The University of Edinburgh. Using a range of invitation strategies, key demographic and clinical data will be collected from those pre-consenting to consider participation in clinical trials. These data will, with consent, in due course, be linkable to other healthcare, social, economic, and genetic datasets. To use the database, asthma investigators will send their eligibility criteria for participant recruitment; eligible participants will then be informed about the new trial and asked if they wish to participate. A steering committee will oversee the running of the database, including approval of usage access. Novel communication strategies will be utilised to engage participants who are recruited into the database in order to avoid attrition as a result of waiting time to participation in a suitable trial, and to minimise the risk of their being approached when already enrolled in a trial.ResultsThe value of this database will be whether it proves useful and usable to researchers in facilitating recruitment into clinical trials on asthma and whether patient privacy and data security are protected in meeting this aim.ConclusionsSuccessful recruitment is fundamental to the success of a clinical trial. The UK Database of Asthma Research Volunteers, the first of its kind in the context of asthma, presents a novel approach to overcoming recruitment barriers and will facilitate the catalysing of important clinical trials on asthma in the UK.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-016-1381-6) contains supplementary material, which is available to authorized users.
Highlights
Randomised clinical trials are the ‘gold standard’ for evaluating the effectiveness of healthcare interventions
We present a conceptual framework for creating a database for the recruitment of volunteers who are willing and eligible to participate in future asthma clinical trials in the UK
Database design and set-up The design and set-up of the database will closely follow the approaches used to establish the generalist National Health Service Scotland (NHS Scotland) Scottish Health Research Register (SHARE) which targets all people in Scotland for recruitment [16]
Summary
Randomised clinical trials are the ‘gold standard’ for evaluating the effectiveness of healthcare interventions. Randomised clinical trials are the ‘gold standard’ for evaluating the effectiveness of interventions in reaching medical and policy decisions [1, 2]. In the UK, only 55 % of trials funded by the National Institute of Health Research Health Technology Assessment (NIHR HTA) and the Medical Research Council achieved their original recruitment target on time, whilst 45 % received an extension of time to recruit [4, 6]. This trend shows no sign of improvement over time [4]. Strategies to improve recruitment into trials include telephone reminders, optout procedures, and open designs, but their impact on enhanced recruitment appears to be marginal [5, 8, 9]
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