Incorporating patient preferences into drug development and regulatory decision making
| Autor: | Hans L. Hillege, Tomas Salmonson, Francesco Pignatti, Isabelle Moulon, Bettina Ryll, Douwe Postmus, Maria Mavris, Ananda Plate, Hans-Georg Eichler, Nathalie Bere |
|---|---|
| Přispěvatelé: | Methods in Medicines evaluation & Outcomes research (M2O), Value, Affordability and Sustainability (VALUE), Groningen Kidney Center (GKC), Life Course Epidemiology (LCE), Cardiovascular Centre (CVC) |
| Jazyk: | angličtina |
| Rok vydání: | 2016 |
| Předmět: |
Decision Making
MEDLINE Pilot Projects Computer-assisted web interviewing Marketing authorization 03 medical and health sciences 0302 clinical medicine Neoplasms Surveys and Questionnaires Agency (sociology) Humans Medicine media_common.cataloged_instance Pharmacology (medical) Preference elicitation Regulatory science European Union 030212 general & internal medicine European union media_common Pharmacology Medical education business.industry Management science 030503 health policy & services Patient Preference Caregivers Drug development Drug Design Drug and Narcotic Control 0305 other medical science business |
| Zdroj: | Clinical Pharmacology & Therapeutics, 99(5), 548-554. Nature Publishing Group |
| ISSN: | 0009-9236 |
| DOI: | 10.1002/cpt.332 |
| Popis: | Currently, patient preference studies are not required to be included in marketing authorization applications to regulatory authorities, and the role and methodology for such studies have not been agreed upon. The European Medicines Agency (EMA) conducted a pilot study to gain experience on how the collection of individual preferences can inform the regulatory review. Using a short online questionnaire, ordinal statements regarding the desirability of different outcomes in the treatment of advanced cancer were elicited from 139 participants (98 regulators, 29 patient or carers, and 12 healthcare professionals). This was followed by face-to-face meetings to gather feedback and validate the individual responses. In this article we summarize the EMA pilot study and discuss the role of patient preference studies within the regulatory review. Based on the results, we conclude that our preference elicitation instrument was easy to implement and sufficiently precise to learn about the distribution of the participants' individual preferences. |
| Databáze: | OpenAIRE |
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