Patient-centred clinical trial design

Tong, Allison; Scholes‐Robertson, Nicole; Hawley, Carmel; Viecelli, Andrea K.; Carter, Simon A.; Levin, Adeera; Hemmelgarn, Brenda R.; Harris, Tess; Craig, Jonathan C.

doi:10.1038/s41581-022-00585-w

Cited by 26 publications

(21 citation statements)

References 98 publications

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“…While some might not want any further contact, others might. A ‘patient-centred’ approach [ 25 ] might mean researchers should find out what each participant wants, wherever possible. Further guidance about how to do this is available on the Persevere website [ 4 ].…”

Section: Discussionmentioning

confidence: 99%

How can we support research participants who stop taking part? Communications guidance developed through public-researcher collaboration

Cragg,

Bishop,

Gilberts

et al. 2024

Res Involv Engagem

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Background Research study participants can stop taking part early, in various circumstances. Sometimes this experience can be stressful. Providing participants with the information they want or need when they stop could improve participants’ experiences, and may benefit individual studies’ objectives and research in general. A group of public contributors and researchers at the Clinical Trials Research Unit, University of Leeds, aimed to develop a communication template and researcher guidance. This would address how to provide information sensitively around the time when participants stop or significantly reduce their level of participation. Methods The project lead used scoping review methods to identify relevant prior evidence and derive a list of potential information topics to communicate to participants who stop taking part. The topic list was reviewed by research professionals and public contributors before finalisation. Further public contributors were identified from a range of networks. The contributors formed a ‘development group’, to work on the detail of the planned resources, and a larger ‘review group’ to review the draft output before finalisation. The involvement was planned so that the development group could shape the direction and pace of the work. Results The literature review identified 413 relevant reports, resulting in 94 information topics. The review suggested that this issue has not been well explored previously. Some evidence suggested early-stopping participants are sometimes excluded from important communications (such as study results) without clear justification. The development group agreed early to focus on guidance with reusable examples rather than a template. We took time to explore different perspectives and made decisions by informal consensus. Review group feedback was broadly positive but highlighted the need to improve resource navigability, leading to its final online form. Conclusions We co-developed a resource to provide support to research participants who stop taking part. A strength of this work is that several of the public contributors have direct lived experience of stopping research participation. We encourage others to review the resource and consider how they support these participants in their studies. Our work highlights the value of researchers and participants working together, including on complex and ethically challenging topics.

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Section: Discussionmentioning

confidence: 99%

How can we support research participants who stop taking part? Communications guidance developed through public-researcher collaboration

Cragg,

Bishop,

Gilberts

et al. 2024

Res Involv Engagem

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“…We have noted that site-level factors sometimes dictate uptake of eConsent and, given the need for trials to be patient-centred [ 23 ], we seek to remove this barrier by understanding challenges at sites and offering further support where we can. Use of methods such as those forming the QuinteT Recruitment Intervention [ 24 ], to understand barriers to recruitment and whether eConsent might help overcome these, may be beneficial.…”

Section: Future Developments At Ctrumentioning

confidence: 99%

Approaches and experiences implementing remote, electronic consent at the Leeds Clinical Trials Research Unit

Cragg,

Taylor,

Moreau

et al. 2024

Trials

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Background Use of electronic methods to support informed consent (‘eConsent’) is increasingly popular in clinical research. This commentary reports the approach taken to implement electronic consent methods and subsequent experiences from a range of studies at the Leeds Clinical Trials Research Unit (CTRU), a large clinical trials unit in the UK. Main text We implemented a remote eConsent process using the REDCap platform. The process can be used in trials of investigational medicinal products and other intervention types or research designs. Our standard eConsent system focuses on documenting informed consent, with other aspects of consent (e.g. providing information to potential participants and a recruiter discussing the study with each potential participant) occurring outside the system, though trial teams can use electronic methods for these activities where they have ethical approval. Our overall process includes a verbal consent step prior to confidential information being entered onto REDCap and an identity verification step in line with regulator guidance. We considered the regulatory requirements around the system’s generation of source documents, how to ensure data protection standards were upheld and how to monitor informed consent within the system. We present four eConsent case studies from the CTRU: two randomised clinical trials and two other health research studies. These illustrate the ways eConsent can be implemented, and lessons learned, including about differences in uptake. Conclusions We successfully implemented a remote eConsent process at the CTRU across multiple studies. Our case studies highlight benefits of study participants being able to give consent without having to be present at the study site. This may better align with patient preferences and trial site needs and therefore improve recruitment and resilience against external shocks (such as pandemics). Variation in uptake of eConsent may be influenced more by site-level factors than patient preferences, which may not align well with the aspiration towards patient-centred research. Our current process has some limitations, including the provision of all consent-related text in more than one language, and scalability of implementing more than one consent form version at a time. We consider how enhancements in CTRU processes, or external developments, might affect our approach.

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“…Trials that are person-centered also acknowledge health disparities and consciously promote health equity through recruiting diverse trial participants and staff, who reflect the demographics of the disease burden. Detailed treatment of the topic is beyond the scope of this publication and an evolving area of scholarship [15,16].…”

Section: Person-centerednessmentioning

confidence: 99%

A framework for assessing clinical trial site readiness

Buse,

Austin,

Johnston

et al. 2023

J. Clin. Trans. Sci.

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Clinical trial processes are unnecessarily inefficient and costly, slowing the translation of medical discoveries into treatments for people living with disease. To reduce redundancies and inefficiencies, a group of clinical trial experts developed a framework for clinical trial site readiness based on existing trial site qualifications from sponsors. The site readiness practices are encompassed within six domains: research team, infrastructure, study management, data collection and management, quality oversight, and ethics and safety. Implementation of this framework for clinical trial sites would reduce inefficiencies in trial conduct and help prepare new sites to enter the clinical trials enterprise, with the potential to improve the reach of clinical trials to underserved communities. Moreover, the framework holds benefits for trial sponsors, contract research organizations, trade associations, trial participants, and the public. For novice sites considering future trials, we provide a framework for site preparation and the engagement of stakeholders. For experienced sites, the framework can be used to assess current practices and inform and engage sponsors, staff, and participants. Details in the supplementary materials provide easy access to key regulatory documents and resources. Invited perspective articles provide greater depth from a systems, DEIA (diversity, equity, inclusion, and accessibility) and decentralized trials perspective.

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Patient-centred clinical trial design

Cited by 26 publications

References 98 publications

How can we support research participants who stop taking part? Communications guidance developed through public-researcher collaboration

How can we support research participants who stop taking part? Communications guidance developed through public-researcher collaboration

Approaches and experiences implementing remote, electronic consent at the Leeds Clinical Trials Research Unit

A framework for assessing clinical trial site readiness

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