Evidence Library

Title: How and Why to Involve Patients in Drug Development: Perspectives From the Pharmaceutical Industry, Regulatory Authorities, and Patient Organisations.
Author: Marianne Botoft Hansen, Lotte Stig Nørgaard, Christine Erikstrup Hallgreen.
Date Published: 2019
Reference: Therapeutic Innovation & Regulatory Science. 1-9.
Are service users or carers authors: No/Not Known

Abstract: Aim: To explore the different views of patient organisations, pharmaceutical companies, and regulatory agencies on patient centred drug development, and to find out how these different views influence the way that patients are involved. Method: 12 interviews with representatives from the three different groups of stakeholder. Results: Three main views of patient involvement were identified as: “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 clear expectations and roles were thought to be essential for effective collaboration. The current culture and mind-sets in the pharmaceutical industry, the lack of a common understanding of involvement, the limited resources amongst patient organisations, and reluctance to share power were perceived as the most important barriers for patient involvement. Conclusion: Based on the findings, the pharmaceutical industry, patient organisations, and regulatory authorities were labelled as “pioneer/dominant,” “unaware/quiet,” and “hesitant,” respectively. Overall, there is limited room for patients in drug development suggesting that the pharmaceutical industry may have the greatest influence on patients’ involvement.

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Categories: health
nature and extent of public involvement in research
journal article

Date Entered: 2019/10/21

Date Edited: 2019/10/21

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