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International Clinical Trials

Assessing Attitudes

Achieving high levels of patient recruitment, adherence, and retention is essential for the successful completion of a clinical trial, yet it remains a significant challenge faced by researchers. Poor patient recruitment, adherence, and retention can adversely affect a trial by lengthening timelines, adding cost and risk to the validity of the data and delaying product approval.

Numerous factors contribute to the process of attracting the patient to consider participating in clinical research studies. These include lacking an awareness of the critical role that clinical trials play; limited access to knowledge about clinical trials; lack of understanding about rights; and safety and benefits. These are among the most common reasons for low participation. In terms of retention in the trial, these can involve patient-centred factors, such as demographic and psychosocial, comprising of their beliefs; attitudes, motivation and severity; therapy-related factors such as treatment complexity adverse reactions and lack of therapeutic impact; and social and economic factors, including the inability to take time off work, lifestyle patterns, etc. Other factors could include clinical trial site location, frequency of clinic visits and clinic staff. In contrast, patients are motivated to participate in clinical trials for reasons including advancing their medical knowledge and gaining access to promising treatment.

The development and integration of patient recruitment and retention strategies that address the issues of a patient’s perceived benefits, barriers, and burden by leveraging both technology and communication is essential to address patient recruitment. However, an additional challenge exists that researchers should consider when developing such strategies. This is the need to take into account the subtle and complex mechanisms that shape people’s behaviour such as whether or not to participate in a clinical trial. This requires an approach, which, to quote Jules Berry, “shines a light on the factors that influence our actions” in an attempt to better understand the subtle and complex mechanisms that impact patient behaviour. It is, to paraphrase Jules Berry, to view the solutions through the prism of Behavioural Economics (BE) (1).

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Keith Meadows has held academic posts at the Universities of London, Newcastle and Hull, UK, undertaking research across much of Europe, including Russia, Spain, Scandinavia and the Low Countries. He has broad experience in health services research, with particular emphasis on the assessment of the psychosocial impact of living with diabetes, health-related quality of life, health survey research and patient-reported outcome measures. Keith founded DHP Research & Consultancy in 2009 to provide research support and training to the healthcare sector, as well as bring innovative approaches to survey and questionnaire design, qualitative data collection and analysis.
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Keith Meadows
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