Patient Preference Studies for Advanced Prostate Cancer Treatment Along the Medical Product Life Cycle: Systematic Literature Review

Author:

Menges DominikORCID,Piatti Michela C,Cerny Thomas,Puhan Milo A

Publisher

Informa UK Limited

Subject

Health Policy,Pharmacology, Toxicology and Pharmaceutics (miscellaneous),Social Sciences (miscellaneous),Medicine (miscellaneous)

Reference50 articles.

1. The Optimal Practice of Evidence-Based Medicine

2. US Food & Drug Administration (FDA). Patient-focused drug development guidance series for enhancing the incorporation of the patient’s voice in medical product development and regulatory decision making; 2020. Available from: https://www.fda.gov/media/139088/download. Accessed May 11, 2022.

3. US Food & Drug Administration (FDA). Patient preference information - voluntary submission, review in premarket approval applications, humanitarian device exemption applications, and de novo requests, and inclusion in decision summaries and device labeling: guidance for industry, food and drug administration staff, and other stakeholders; 2016. Available from: https://www.fda.gov/media/92593/download. Accessed May 11, 2022.

4. European Medicines Agency (EMA). The patient’s voice in the evaluation of medicines; 2013. Available from: https://www.ema.europa.eu/en/documents/report/report-workshop-patients-voice-evaluation-medicines_en.pdf. Accessed May 11, 2022.

5. Patient-Focused Benefit-Risk Analysis to Inform Regulatory Decisions: The European Union Perspective

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