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Abstract
BackgroundRecruitment is a major challenge for many trials; just over half reach their targets and almost a third resort to grant extensions. The economic and societal implications of this shortcoming are significant. Yet, we have a limited understanding of the processes that increase the probability that recruitment targets will be achieved. Accordingly, there is an urgent need to bring analytical rigour to the task of improving recruitment, thereby increasing the likelihood that trials reach their recruitment targets. This paper presents a conceptual framework that can be used to improve recruitment to clinical trials.MethodsUsing a case-study approach, we reviewed the range of initiatives that had been undertaken to improve recruitment in the txt2stop trial using qualitative (semi-structured interviews with the principal investigator) and quantitative (recruitment) data analysis. Later, the txt2stop recruitment practices were compared to a previous model of marketing a trial and to key constructs in social marketing theory.ResultsPost hoc, we developed a recruitment optimisation model to serve as a conceptual framework to improve recruitment to clinical trials. A core premise of the model is that improving recruitment needs to be an iterative, learning process. The model describes three essential activities: i) recruitment phase monitoring, ii) marketing research, and iii) the evaluation of current performance. We describe the initiatives undertaken by the txt2stop trial and the results achieved, as an example of the use of the model.ConclusionsFurther research should explore the impact of adopting the recruitment optimisation model when applied to other trials.
Highlights
Recruitment is a major challenge for many trials; just over half reach their targets and almost a third resort to grant extensions
The potential for marketing constructs to be used to improve the management of clinical trials remains largely unexplored, Francis et al [9] have suggested the use of marketing models and techniques beneficial for trialists and which can be understood as a five-stage process (Figure 1)
Study purpose We aimed to generate a new, or to refine an existing trials-orientated marketing framework, based on the analysis of the txt2stop case and relevant literature from social marketing and clinical trials, that can be used by other trialists to improve recruitment
Summary
Recruitment is a major challenge for many trials; just over half reach their targets and almost a third resort to grant extensions. There is an urgent need to bring analytical rigour to the task of improving recruitment, thereby increasing the likelihood that trials reach their recruitment targets. In order to improve recruitment rates there have been calls to apply greater analytical rigour and more insightful management practices [7] including the suggestion that the performance of clinical trials could be improved by looking beyond the world of clinical practice, by using marketing principles [7,8,9]. The potential for marketing constructs to be used to improve the management of clinical trials remains largely unexplored, Francis et al [9] have suggested the use of marketing models and techniques beneficial for trialists and which can be understood as a five-stage process (Figure 1)
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