دورية أكاديمية
Balancing ethical norms and duties for the introduction of new medicines through conditional marketing authorization: a research agenda.
| العنوان: | Balancing ethical norms and duties for the introduction of new medicines through conditional marketing authorization: a research agenda. |
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| المؤلفون: | Maksimova MV; Department of Bioethics and Health Humanities, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, Netherlands., van Thiel GJMW; Department of Bioethics and Health Humanities, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, Netherlands., Tromp Y; Department of Bioethics and Health Humanities, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, Netherlands., Lechner R; Department of Clinical Genetics, Erasmus Medical Center, Rotterdam, Netherlands., van Delden JJM; Department of Bioethics and Health Humanities, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, Netherlands., Bloem LT; Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, Netherlands. |
| المصدر: | Frontiers in medicine [Front Med (Lausanne)] 2024 Jun 24; Vol. 11, pp. 1408553. Date of Electronic Publication: 2024 Jun 24 (Print Publication: 2024). |
| نوع المنشور: | Journal Article |
| اللغة: | English |
| بيانات الدورية: | Publisher: Frontiers Media S.A Country of Publication: Switzerland NLM ID: 101648047 Publication Model: eCollection Cited Medium: Print ISSN: 2296-858X (Print) Linking ISSN: 2296858X NLM ISO Abbreviation: Front Med (Lausanne) Subsets: PubMed not MEDLINE |
| أسماء مطبوعة: | Original Publication: Lausanne, Switzerland : Frontiers Media S.A., [2014]- |
| مستخلص: | The European Medicines Agency's conditional marketing authorization (CMA) aims to expedite patient access to medicines for unmet medical needs by shifting a part of the drug development process post-authorization. We highlight ethical issues surrounding CMA, comprising (i) the complexity of defining unmet medical need; (ii) poor understanding of CMA and its impact on informed consent; (iii) hope versus unrealistic optimism; (iv) implications of prolonged post-authorization studies and potential patient harm; (v) rights and duties of patients surrounding participation in post-authorization studies; (vi) access to previously authorized CMA medicines; and (vii) the "benefit slippage" phenomenon, defined as the gradual shift of strict criteria to less strict criteria. We propose a comprehensive research agenda to address these ethical issues, and stress the need for multi-stakeholder engagement to ensure patient-centered use of CMA. Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. (Copyright © 2024 Maksimova, van Thiel, Tromp, Lechner, van Delden and Bloem.) |
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| فهرسة مساهمة: | Keywords: European Medicines Agency; clinical ethics; conditional marketing authorization; expedited regulatory pathways; informed consent; research ethics; uncertainty; unmet medical need |
| تواريخ الأحداث: | Date Created: 20240715 Latest Revision: 20240716 |
| رمز التحديث: | 20240716 |
| مُعرف محوري في PubMed: | PMC11242744 |
| DOI: | 10.3389/fmed.2024.1408553 |
| PMID: | 39005652 |
| قاعدة البيانات: | MEDLINE |
Full Text Finder | تدمد: | 2296-858X |
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| DOI: | 10.3389/fmed.2024.1408553 |