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Partnering with patients to get better outcomes with chimeric antigen receptor T-cell therapy: towards engagement of patients in early phase trials.

ABSTRACT: Aim:Though patient engagement in clinical research is growing, recent reports suggest few clinical trials report on such activities. To address this gap, we describe our approach to patient engagement in the development of a clinical trial protocol to assess a new immunotherapy for blood cancer (chimeric antigen receptor T-cell therapy, CAR-T cell therapy). Methods:Our team developed a clinical trial protocol by working with patient partners from inception. Two patient partners with lived blood cancer experience were identified through referrals from our team's professional network and patient organization contacts. Our patient partners were onboarded to the team and engaged in several studies conducted to develop the clinical trial protocol, including a systematic review of the existing literature on the therapy, patient interviews and a survey to obtain perspectives on barriers and enablers to participating in the trial, an early economic analysis, and a retrospective cohort study. Results:Engaging patient partners enhanced our research in ways that would not have otherwise occurred. By selecting patient important outcomes for data collection, our partners helped flag that quality of life and health utility measures have not been reported in previous CAR-T cell therapy trials for blood cancer. Our partners also co-developed a non-technical summary of the systematic review that summarized results in an accessible manner. Our patient partners reviewed interview and survey questions, to improve the language and appropriateness; provided recruitment suggestions; and provided a patient perspective on the results, thereby confirming the importance of findings. Input was also obtained on costs for the early economic analysis. Our patient partners identified costs that may be a burden to both patients and caregivers during a trial and helped to confirm that the overall structure of the economic model reflected the patient care pathway. Our patient partners also shared their diagnosis and treatment stories, which helped to provide the research team with insight into this experience. Conclusions:Contributions by our patient partners were invaluable to each component study, as well as the overall development of the trial protocol. We plan to use this approach in the future in order to meaningfully engage patients in the development of other clinical trials; we also hope that by reporting our methods this will help other research teams to do the same. Trial registration:Affiliated with the development of NCT03765177.

SUBMITTER: Foster M

PROVIDER: S-EPMC7557015 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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Partnering with patients to get better outcomes with chimeric antigen receptor T-cell therapy: towards engagement of patients in early phase trials.

Foster Madison M Fergusson Dean A DA Hawrysh Terry T Presseau Justin J Kekre Natasha N Schwartz Stuart S Castillo Gisell G Asad Sarah S Fox Grace G Atkins Harold H Thavorn Kednapa K Montroy Joshua J Holt Robert A RA Monfaredi Zarah Z Lalu Manoj M MM

Research involvement and engagement 20201014

<h4>Aim</h4>Though patient engagement in clinical research is growing, recent reports suggest few clinical trials report on such activities. To address this gap, we describe our approach to patient engagement in the development of a clinical trial protocol to assess a new immunotherapy for blood cancer (chimeric antigen receptor T-cell therapy, CAR-T cell therapy).<h4>Methods</h4>Our team developed a clinical trial protocol by working with patient partners from inception. Two patient partners wi ...[more]

PMID: 33072399

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Project description:BACKGROUND:Around the world, many healthcare organizations engage patients as a quality improvement strategy. In Canada, the University of Montreal has developed a model which consists in partnering with patient advisors, providers, and managers in quality improvement. This model was introduced through its Partners in Care Programs tested with several quality improvement teams in Quebec, Canada. Partnering with patients in quality improvement brings about new challenges for healthcare managers. This model is recent, and little is known about how managers contribute to implementing and sustaining it using key practices. METHODS:In-depth multi-level case studies were conducted within two healthcare organizations which have implemented a Partners in Care Program in quality improvement. The longitudinal design of this research enabled us to monitor the implementation of patient partnership initiatives from 2015 to 2017. In total, 38 interviews were carried out with managers at different levels (top-level, mid-level, and front-line) involved in the implementation of Partners in Care Programs. Additionally, seven focus groups were conducted with patients and providers. RESULTS:Our findings show that managers are engaged in four main types of practices: 1-designing the patient partnership approach so that it makes sense to the entire organization; 2-structuring patient partnership to support its deployment and sustainability; 3-managing patient advisor integration in quality improvement to avoid tokenistic involvement; 4-evaluating patient advisor integration to support continuous improvement. Designing and structuring patient partnership are based on typical management practices used to implement change initiatives in healthcare organizations, whereas managing and evaluating patient advisor integration require new daily practices from managers. Our results reveal that managers at all levels, from top to front-line, are concerned with the implementation of patient partnership in quality improvement. CONCLUSION:This research adds empirical support to the evidence regarding daily managerial practices used for implementing patient partnership initiatives in quality improvement and contributes to guiding healthcare organizations and managers when integrating such approaches.

Dataset Information

Partnering with patients to get better outcomes with chimeric antigen receptor T-cell therapy: towards engagement of patients in early phase trials.

Publications

Partnering with patients to get better outcomes with chimeric antigen receptor T-cell therapy: towards engagement of patients in early phase trials.

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