Galli Leandro, Knight Rosemary, Robertson Steven, Hoile Elizabeth, Oladapo Olubukola, Francis David, Free Caroline
London School of Hygiene and Tropical Medicine, Coventry CV4 7AL, UK.
Trials. 2014 May 22;15:182. doi: 10.1186/1745-6215-15-182.
Recruitment 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.
Using 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.
Post 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.
Further research should explore the impact of adopting the recruitment optimisation model when applied to other trials.
招募是许多试验面临的一项重大挑战;只有略超过半数的试验能达到目标,近三分之一的试验不得不申请延长资助。这一缺陷对经济和社会产生的影响重大。然而,我们对那些能提高实现招募目标可能性的过程了解有限。因此,迫切需要在改善招募工作中引入严谨的分析方法,从而增加试验达到招募目标的可能性。本文提出了一个可用于改善临床试验招募工作的概念框架。
采用案例研究方法,我们运用定性(与主要研究者进行半结构化访谈)和定量(招募)数据分析,回顾了在txt2stop试验中为改善招募所采取的一系列举措。随后,将txt2stop的招募实践与之前的试验营销模式以及社会营销理论中的关键概念进行了比较。
事后,我们开发了一个招募优化模型,作为改善临床试验招募工作的概念框架。该模型的一个核心前提是,改善招募需要是一个迭代的学习过程。该模型描述了三项基本活动:i)招募阶段监测,ii)市场调研,以及iii)对当前表现的评估。我们以txt2stop试验所采取的举措及取得的结果为例,阐述了该模型的应用。
进一步的研究应探讨采用招募优化模型应用于其他试验时所产生的影响。