How and Why to Involve Patients in Drug Development: Perspectives From the Pharmaceutical Industry, Regulatory Authorities, and Patient Organizations

Therapeutic Innovation & Regulatory Science
Marianne Botoft HansenChristine Erikstrup Hallgreen

Abstract

Despite increasing interest and focus on patient-centric approaches to drug development, there might still be divergent views between key stakeholders in how to perceive patient involvement and how possibly divergent views influence the role of patients in the drug development process. The objective of this study is to explore how the perception of patient organizations, pharmaceutical companies, and regulatory agencies influence the role of patients in drug development. A qualitative interview study based on 12 semi-structured interviews with representatives from the 3 stakeholders. Interviews were transcribed, and data were analyzed using a social constructivist approach in the form of systematic text condensation. Three main perceptions of patient involvement were identified: "a way to improve quality of life," "a way to avoid business failure," and "a way to foster a faster drug approval process." Transparency, trust, and clarification of expectations and roles were factors perceived as prerequisites for a valuable collaboration. Furthermore, a required cultural mindset change in the pharmaceutical industry, the lack of a common framework, patient organizations having limited resources available, and concerns about what to ...Continue Reading

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May 1, 2021·Current Oncology·Stéphanie MichaudBarry D Stein
May 23, 2021·Research in Social & Administrative Pharmacy : RSAP·Joo Hanne PoulsenLotte Stig Nørgaard

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