Patients’ involvement in the development of pharmaceutical products at pre-launch: problems experienced and how to resolve them
DOI:
https://doi.org/10.6092/2282-1619/mjcp-2363Keywords:
Market access, Pre-launch, Target products profile, Product development plan, Design of clinical trials, Food and Drug Administration.Abstract
Background: Pharmaceutical products are developed for patients as the end-users. It has been advocated that patients should be involved in the development of such products. However, this is not the case as patients are usually not involved. To date, no study has investigated the involvement of patients at pre-launch stage of pharmaceutical products. Therefore, this study explored patients’ involvement at this stage of pharmaceutical products development.
Methods: A survey of Market Access (MA) and Health Economic and Outcomes Research (HEOR) professionals at International Society for Pharmacoeconomics and Outcomes Research (ISPOR) Glasgow 2017 was carried out. Responses were examined using thematic and descriptive analyses to capture professionals’ suggestions about involvement of patients at pre –launch stage and how to resolve issues identified.
Results: Results showed patients are not currently involved in this process, depriving them of benefits associated with involvement such as improved psychological well-being, health outcomes and drug safety. Participants advocated involvement of patients in the developments of pharmaceutical products. This may help improve adherence and quality of life in patients hence, ensuring effective use of pharmaceutical products.
Conclusion: Patients are to be involved at pre-launch stage of pharmaceutical product development. Their involvement can ensure adherence to early stage development regulations. This may facilitate effective networking among stakeholders. Whilst it is generally agreed that patients should be involved to ensure adherence to regulations, problems are experienced that could be resolved by effective communication; understanding of external issues and how to tackle them. Also, it may help with deeper understanding of issues important to patients.References
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