Marianne Botoft Hansen1, Lotte Stig Nørgaard2, Christine Erikstrup Hallgreen1. 1. 1 Copenhagen Centre for Regulatory Science, Department of Pharmacy, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark. 2. 2 Social and Clinical Pharmacy, Department of Pharmacy, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.
Abstract
BACKGROUND: 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. METHOD: 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. RESULTS: 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 do with patient responsibility were perceived as the most important barriers for patient involvement. CONCLUSION: Based on the findings, the pharmaceutical industry, patient organizations, and regulatory authorities were labeled as "pioneer/dominant," "unaware/quiet," and "hesitant," respectively. The 3 behavioural descriptors reflect a limited negotiation of the role patients have in drug development. Thus, the pharmaceutical industry appears to be the largest influencer with regard to patients' role in drug development.
BACKGROUND: 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. METHOD: 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. RESULTS: 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 do with patient responsibility were perceived as the most important barriers for patient involvement. CONCLUSION: Based on the findings, the pharmaceutical industry, patient organizations, and regulatory authorities were labeled as "pioneer/dominant," "unaware/quiet," and "hesitant," respectively. The 3 behavioural descriptors reflect a limited negotiation of the role patients have in drug development. Thus, the pharmaceutical industry appears to be the largest influencer with regard to patients' role in drug development.
Entities:
Keywords:
Patient involvement; drug development; patient engagement; qualitative; regulatory science; social constructivism