How and Why to Involve Patients in Drug Development: Perspectives from the Pharmaceutical Industry, Regulatory Authorities and Patient Organizations
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How and Why to Involve Patients in Drug Development : Perspectives from the Pharmaceutical Industry, Regulatory Authorities and Patient Organizations. / Hansen, Marianne Botoft; Nørgaard, Lotte Stig; Hallgreen, Christine Erikstrup.
In: Therapeutic Innovation & Regulatory Science, Vol. 54, 2020, p. 577-585.Research output: Contribution to journal › Journal article › Research › peer-review
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TY - JOUR
T1 - How and Why to Involve Patients in Drug Development
T2 - Perspectives from the Pharmaceutical Industry, Regulatory Authorities and Patient Organizations
AU - Hansen, Marianne Botoft
AU - Nørgaard, Lotte Stig
AU - Hallgreen, Christine Erikstrup
PY - 2020
Y1 - 2020
N2 - 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 patientorganizations, 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 textcondensation. Results: Three main perceptions of patient involvement were identified: “a way to improve quality of life,” “a way to avoid businessfailure,” 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 ofthe role patients have in drug development. Thus, the pharmaceutical industry appears to be the largest influencer with regard to patients’ role in drug development.
AB - 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 patientorganizations, 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 textcondensation. Results: Three main perceptions of patient involvement were identified: “a way to improve quality of life,” “a way to avoid businessfailure,” 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 ofthe role patients have in drug development. Thus, the pharmaceutical industry appears to be the largest influencer with regard to patients’ role in drug development.
U2 - 10.1007/s43441-019-00090-6
DO - 10.1007/s43441-019-00090-6
M3 - Journal article
C2 - 31390896
VL - 54
SP - 577
EP - 585
JO - Therapeutic Innovation & Regulatory Science
JF - Therapeutic Innovation & Regulatory Science
SN - 2168-4790
ER -
ID: 223127341