From adaptive licensing to adaptive pathways: Delivering a flexible life‐span approach to bring new drugs to patients-Reference-Cited by-同舟云学术

From adaptive licensing to adaptive pathways: Delivering a flexible life‐span approach to bring new drugs to patients

Published:2015-02-04 Issue:3 Volume:97 Page:234-246
ISSN:0009-9236
Container-title:Clinical Pharmacology & Therapeutics
language:en
Short-container-title:Clin. Pharmacol. Ther.

Author:

Eichler H‐G¹,Baird LG²,Barker R³,Bloechl‐Daum B¹⁴,Børlum‐Kristensen F⁵,Brown J⁶,Chua R⁷,Del Signore S⁸,Dugan U⁹,Ferguson J¹⁰,Garner S¹¹,Goettsch W¹²,Haigh J¹³,Honig P¹⁴,Hoos A¹⁵,Huckle P¹⁶,Kondo T¹⁷,Le Cam Y¹⁸,Leufkens H¹¹⁹,Lim R²⁰,Longson C¹¹,Lumpkin M²¹,Maraganore J²²,O'Rourke B²³,Oye K²⁴,Pezalla E²⁵,Pignatti F¹,Raine J¹²⁶,Rasi G¹²⁷,Salmonson T¹²⁸,Samaha D²⁹,Schneeweiss S³⁰,Siviero PD³¹,Skinner M³²,Teagarden JR³³,Tominaga T¹⁷,Trusheim MR³⁴,Tunis S³⁵,Unger TF³⁶,Vamvakas S¹,Hirsch G²

Affiliation:

1. European Medicines Agency (EMA)London UK

2. Center for Biomedical InnovationMassachusetts Institute of Technology (MIT)Cambridge MA USA

3. Centre for the Advancement of Sustainable Medical Innovation (CASMI)London UK

4. Medical University of ViennaVienna AT

5. European network for health technology assessment (EUnetHTA)Danish Health and Medicines AuthorityCopenhagen DK

6. Pilgrim Health Care Institute and Harvard Medical SchoolBoston MA USA

7. Health Sciences Authority (HSA) Singapore

8. Sanofi‐Aventis, Chilly‐Mazarin FR

9. Global Clinical ResearchBristol‐Myers SquibbWallingford CT USA

10. Novartis Vaccines & Diagnostics ‐ Cambridge MA USA

11. National Institute for Health and Care Excellence (NICE)London UK

12. Zorginstituut NederlandDiemen NL

13. Amgen LtdUxbridge UK

14. Collegeville PA USA

15. M4P (Medicines 4 Patients) ConsultingLondon UK

16. GlaxoSmithKlineResearch Triangle Park NC USA

17. Pharmaceuticals and Medical Devices Agency (PMDA)Tokyo Japan

18. European Organisation for Rare Diseases (EURORDIS)Paris France

19. College ter Beoordeling van Geneesmiddelen Medicines Evaluation Board (CBG/MEB) & University of UtrechtUtrecht NL

20. Health CanadaOttawa ON Canada

21. Bill and Melinda Gates FoundationSeattle WA USA

22. Alnylam Pharmaceuticals, Cambridge, MA, USA and Biotechnology Industry Association (BIO)Washington DC USA

23. Canadian Agency for Drugs and Technologies in Health (CADTH)Ottawa ON Canada

24. Massachusetts Institute of Technology (MIT)Cambridge MA USA

25. AETNAHartford CT USA

26. Medicines and Healthcare Products Regulatory Agency (MHRA)London UK

27. University of Rome Tor Vergata

28. LäkemedelsverketUppsala SE

29. Institut national d'excellence en santé et en services sociaux (INESSS)Quebec Canada

30. Harvard Medical SchoolBoston MA USA

31. Agenzia Italiana del Farmaco (AIFA) & Medicine Evaluation Committee (MEDEV)Rome Italy

32. Panel member of the Patient‐Centered Outcomes Research Institute (PCORI) Advisory Panel on Rare DiseaseWashington DC USA

33. National Organization for Rare Disorders (NORD)Danbury CT USA

34. Sloan School of ManagementMassachusetts Institute of Technology (MIT)Cambridge MA USA

35. Center for Medical Technology Policy (CMTP)Baltimore MD USA

36. Naia Pharmaceuticals and Massachusetts Institute of Technology (MIT)Cambridge MA USA

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/cpt.59

Reference73 articles.

1. Evidence vs. Access: Can Twenty-First-Century Drug Regulation Refine the Tradeoffs?

2. Accelerated Access to Innovative Medicines for Patients in Need

3. Commission Regulation (EC) No 507/2006. . Accessed 4 July2014.

4. HEALTH TECHNOLOGY ASSESSMENT, VALUE-BASED DECISION MAKING, AND INNOVATION

5. Balancing Societal Needs and Regulatory Certainty: The Case Study of Peramivir in Japan

Cited by 161 articles. 订阅此论文施引文献订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献

1. Evolving assessment pathways for precision oncology medicines to improve patient access: a tumor-agnostic lens;The Oncologist;2024-04-17

2. Design differences and variation in results between randomised trials and non-randomised emulations: meta-analysis of RCT-DUPLICATE data;BMJ Medicine;2024-02

3. The FAIRification of research in real‐world evidence: A practical introduction to reproducible analytic workflows using Git and R;Pharmacoepidemiology and Drug Safety;2024-01

4. Design differences explain variation in results between randomized trials and their non-randomized emulations;2023-07-13

5. RAPID framework for improved access to precision oncology for lethal disease: Results from a modified multi-round delphi study;Frontiers in Health Services;2023-02-27