A secondary qualitative analysis of stakeholder views about participant recruitment, retention, and adherence in decentralised clinical trials (DCTs)

Abstract

Background Decentralised clinical trials (DCTs) are clinical trials where all or most trial activities occur in or near participants’ homes instead of hospitals or research sites. While more convenient for participants, DCTs may offer limited opportunities to build trust with investigators and trial teams. This qualitative analysis explored DCT stakeholder views to inform strategies for maximising participant recruitment, retention, and adherence. Methods A secondary analysis of original interview transcripts focused on participant engagement: recruitment, retention, and adherence. Semi-structured interviews were conducted with a purposive sample of stakeholders, including trial managers and administrators, investigators, nurses, vendors, and patient representatives. Interview data were coded using a thematic approach to generate descriptive themes. Results Forty-eight stakeholders were interviewed. Three components of participant engagement in DCTs were identified: identifying and attracting potential participants, retaining participants and encouraging adherence, and involvement of patients and the public. Interviewees believed that a potential participant’s beliefs about research value and their trust in the research team strongly influenced the likelihood of taking part in a DCT. Early involvement of patients was identified as one way to gauge participant priorities. However, perceived burden was seen as a barrier to recruitment. Factors influencing retention and adherence were related to the same underlying motivators that drove recruitment: personal values, circumstances, and burden. Being part of a DCT should not conflict with the original motivations to participate. Conclusion Recruitment, retention, and adherence in DCTs are driven by factors that have previously been found to affect conventional clinical trials. Increasing patient and public involvement can address many of these factors. In contrast to conventional trials, DCTs are perceived as requiring greater emphasis on communication, and contact, to engender trust between participants and researchers despite a relative lack of in-person interaction.

Allopurinol and cardiovascular outcomes in patients with ischaemic heart disease: the ALL-HEART RCT and economic evaluation

“…In recent years, decentralised clinical trial processes have been gaining popularity, having accelerated in their use during the COVID-19 pandemic, and knowledge about the best approaches to optimising participant experiences, inclusivity and study processes is expanding significantly. [45][46][47][48] Allopurinol is generally the first-line urate-lowering therapy for patients with gout. However, a newer and more potent xanthine oxidase inhibitor, febuxostat, also became available a few years ago.…”

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“…Some are motivated by “conditional altruism,” a primary desire for personal gain reinforced by an incidental benefit to others ( 8 ). For some participants, believing in the importance of the trial is a decisive element ( 12 , 16 ).…”

“…There is an ongoing trend among researchers and patient advocates for greater inclusivity among clinical trial participants so that the knowledge base is demographically representative of patients ( 16 , 27 – 29 , 31 ). As for many studies, recruitment goals should go beyond sufficient sample size to include sufficiently diverse representation among enrollees.…”

Adapting to Decentralised Clinical Trials: Analysis of Trial Clinician's Experiences and Impacts on the Patient-Centred Experience (Preprint)

“…DCTs utilise digital technologies to enable remote patient access to research, data gathering, and communication [14]. Data collection and assessments are now often carried out in participants' homes through technology [15], replacing traditional on-site data collection, minimising physical site attendance and emphasising participant-technology interactions over site staff interactions [16]. Integrating technologies such as smart devices, wearables, and sensors for data collection and processing [17].…”

“…As the field progresses, there is an increasing demand for additional research to delve into stakeholders' perspectives on DCT [36]. Further investigation has been recommended to explore the effects of decentralised methods on stakeholders' challenges and patient participation experiences [16], [37]. Therefore, it is imperative to evaluate the effectiveness of current practices in achieving this goal.…”