Giving Voice to Clinical Study Participants: Development and Deployment of Sequential Patient Experience Surveys for Global Clinical Studies.
Ther Innov Regul Sci
; 54(5): 1001-1009, 2020 09.
Article
en En
| MEDLINE
| ID: mdl-31965539
ABSTRACT
BACKGROUND:
Biopharmaceutical companies are piloting patient experience surveys (PES) to help enhance patient satisfaction with clinical studies. However, most PES have been conducted at study close-out, which can hinder recall and responsiveness, and at a limited number of sites, which restricts their applicability to global studies. Our aim was to investigate the feasibility of developing sequential PES, which would be deployed globally, and to provide practical recommendations based on our real-world experience.METHODS:
To develop sequential PES (introductory, interim, close-out), we customized a previously developed patient experience close-out survey. Extensive input was gained from multiple stakeholders (e.g., survey experts, patient advisors, psychometricians, clinical trialists, lawyers). To deploy the PES in global studies, we prepared PES-specific ethics committee submissions, training materials (e.g., slides, videos), and PES invitation aids (postcards, digital app reminders).RESULTS:
Developing and deploying sequential PES in global clinical studies was feasible. The 3-part online PES (25 to 37 questions per survey) passed health literacy testing. To facilitate benchmarking, the PES included core questions (including a Net Promoter Score question). The PES gained ethics approval and was deployed globally in 2017-2018 in 12 phase 2 and 3 clinical studies in North America, Europe, and the Asia-Pacific. Based on the real-world insights gained and the challenges encountered, we have made recommendations for PES.CONCLUSIONS:
Our practical recommendations on the development and deployment of sequential global PES may assist others to implement PES efficiently and effectively, allowing them to gain feedback from patients globally during clinical studies.Palabras clave
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Satisfacción del Paciente
/
Evaluación del Resultado de la Atención al Paciente
Tipo de estudio:
Guideline
Aspecto:
Ethics
/
Patient_preference
Límite:
Humans
País/Región como asunto:
Asia
/
Europa
Idioma:
En
Revista:
Ther Innov Regul Sci
Año:
2020
Tipo del documento:
Article
País de afiliación:
Estados Unidos