Incorporating Patient Advocates in Oncology Clinical Development: Lessons Learned From a Novel Pilot Program.
Ther Innov Regul Sci
; 53(3): 349-353, 2019 05.
Article
en En
| MEDLINE
| ID: mdl-30089395
The advent of patient-focused drug development (PFDD) has underscored the priority of engaging the "voice of the patient" in therapy development. Industry sponsors are working to enhance engagement of patients early, particularly within decision making for design and execution of clinical trials. This trend is especially significant within oncology, as industry leaders partner with patient advocacy organizations, individual patients, and clinicians to enhance patient-centricity. These partnerships often require a willingness to change attitudes, approaches, and processes to reshape traditional models of drug development. In 2016, Bayer Oncology launched a pilot program called the Patient Advocate Advisory Council (PAAC), to design and execute a program whereby patients join clinical development teams. The PAAC, composed of experienced patient advocates from the US and Europe, worked closely with company leaders to design and execute a pilot in an ongoing clinical development program. The PAAC and Bayer teams have identified important learnings from the first phase of the program, emphasizing earlier engagement of patient advisors, launching the enhanced training platform, and recruiting additional PAAC members to expand the initiative's reach across the cancer community. A critical success factor is having champions for patient engagement within the company to ensure that activities are streamlined and standardized as patient engagement becomes more common. This is particularly important given that patient engagement should be a long-term investment with sufficient and sustained resources. PAAC members and Bayer have committed to sharing learnings, to advance opportunities for successful patient engagement in drug development throughout the oncology therapeutic landscape.
Palabras clave
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Defensa del Paciente
/
Ensayos Clínicos como Asunto
/
Neoplasias
Tipo de estudio:
Prognostic_studies
Aspecto:
Patient_preference
Límite:
Humans
País/Región como asunto:
America do norte
/
Europa
Idioma:
En
Revista:
Ther Innov Regul Sci
Año:
2019
Tipo del documento:
Article
País de afiliación:
Estados Unidos
Pais de publicación:
Suiza