January 2018 – May 2018

  • Berger ML. The joint ISPOR-ISPE Special Task Force on real-world evidence in health care decision making: an interview with Marc Berger. J.2018 Jan;comp. eff. res.. 7(1):11-3. PubMed: PM29052427
  • Bouvy JC, Sapede C, Garner S. Managed Entry Agreements for Pharmaceuticals in the Context of Adaptive Pathways in Europe. Front Pharmacol. 2018;9:280, 2018. PubMed: PM29636692
  • Dal-Re R. Could phase 3 medicine trials be tagged as pragmatic? A case study: The Salford COPD trial. J Eval Clin Pract. 2018 Feb;24(1):258-61. PubMed: PM28685913
  • Dal-Re R, Janiaud P, Ioannidis JPA. Real-world evidence: How pragmatic are randomized controlled trials labeled as pragmatic? BMC Med. 2018 Apr 3;16(1):49, 2018. PubMed: PM29615035
  • Dubromel A, Geffroy L, Aulagner G, Dussart C. Assessment and diffusion of medical innovations in France: an overview. J Mark Access Health Policy. 2018;6(1):1458575, 2018. PubMed: PM29686802
  • Garrison LP, Jr., Neumann PJ, Willke RJ, Basu A, Danzon PM, Doshi JA, et al. A Health Economics Approach to US Value Assessment Frameworks-Summary and Recommendations of the ISPOR Special Task Force Report [7. Value Health. 2018 Feb;21(2):161-5. PubMed: PM29477394
  • Goldberg KB, Blumenthal GM, McKee AE, Pazdur R. The FDA Oncology Center of Excellence and precision medicine. Exp Biol Med (Maywood). 2018 Feb;243(3):308-12. PubMed: PM29105511
  • de GS, van der LN, Franken MG, Blommestein HM, Leeneman B, van RE, et al. Balancing the Optimal and the Feasible:
  • A Practical Guide for Setting Up Patient Registries for the Collection of Real-World Data for Health Care Decision Making Based on Dutch Experiences. Value Health. 2017 Apr;20(4):627-36. PubMed: PM28408005
  • Hanna E, Toumi M, Dussart C, Borissov B, Dabbous O, Badora K, et al. Funding breakthrough therapies: A systematic review and recommendation. Health Policy. 2018 Mar;122(3):217-29. PubMed: PM29223847 Hofer MP, Hedman H, Mavris M, Koenig F, Vetter T, Posch M, et al. Marketing authorisation of orphan medicines in Europe from 2000 to 2013. Drug Discov Today. 2018 Feb;23(2):424-33. PubMed: PM29074441
  • Jokura Y, Yano K, Yamato M. Comparison of the new Japanese legislation for expedited approval of regenerative medicine products with the existing systems in the USA and European Union. J Tissue Eng Regen Med. 2018 Feb;12(2):e1056-e1062. PubMed: PM28211195
  • Kondo H, Saint-Raymond A, Yasuda N. What to Know About Medicines With New Active Ingredients Approved in FY 2016 / 2016 in Japan and EU: A Brief Comparison of New Medicines Approved in Japan and the EU in 2016. Ther. 2018 Mar;innov. regul. sci.. 52(2):214-9. PubMed: PM29714521 Lexchin J. Quality of evidence considered by Health Canada in granting full market authorisation to new drugs with a conditional approval: a retrospective cohort study. BMJ Open. 2018 Apr 28;8(4):e020377, 2018. PubMed: PM29705760
  • Makady A, van VA, Jonsson P, Moseley O, d’Andon A, De BA, et al. Using Real-World Data in Health Technology Assessment (HTA) Practice: A Comparative Study of Five HTA Agencies. Pharmacoeconomics. 2018 Mar;36(3):359-68. PubMed: PM29214389
  • Malone DC, Brown M, Hurwitz JT, Peters L, Graff JS. Real-World Evidence: Useful in the Real World of US Payer Decision Making? How? When? And What Studies? Value Health. 2018 Mar;21(3):326-33. PubMed: PM29566840
  • Marsh KD, Sculpher M, Caro JJ, Tervonen T. The Use of MCDA in HTA: Great Potential, but More Effort Needed. Value Health. 2018 Apr;21(4):394-7. PubMed: PM29680094
  • Olberg B, Fuchs S, Panteli D, Perleth M, Busse R. Scientific Evidence in Health Technology Assessment Reports: An In-Depth Analysis of European Assessments on High-Risk Medical Devices. Value Health.2017 Dec;20(10):1420-6. PubMed: PM29241902
  • Oude RK, Kalkman S, Collier S, Ciaglia A, Worsley SD, Lightbourne A, et al. Series: Pragmatic trials and real world evidence: Paper 3. Patient selection challenges and consequences. J Clin Epidemiol.2017 Sep;89:173-180, 2017 Sep:-180. PubMed: PM28502808
  • Robinson MF, Mihalopoulos C, Merlin T, Roughead E. CHARACTERISTICS OF MANAGED ENTRY AGREEMENTS IN AUSTRALIA. Int J Technol Assess Health Care. 2018 Jan;34(1):46-55. PubMed: PM29277174
  • Sun J, Hu CJ, Stuntz M, Hogerzeil H, Liu Y. A review of promoting access to medicines in China – problems and recommendations. BMC Health Serv Res. 2018 Feb 20;18(1):125, 2018. PubMed: PM29458428 Sun X, Tan J, Tang L, Guo JJ, Li X. Real world evidence: experience and lessons from China. BMJ. 2018 Feb 5;360:j5262, 2018 02 05. PubMed: PM29437644
  • Tafuri G, Lucas I, Estevao S, Moseley J, d’Andon A, Bruehl H, et al. The impact of parallel regulatory-health technology assessment scientific advice on clinical development. Assessing the uptake of regulatory and health technology assessment recommendations. Br J Clin Pharmacol. 2018 May;84(5):1013-9. PubMed: PM29370449
  • Trifiro G, Marciano I, Ingrasciotta Y. Interchangeability of biosimilar and biological reference product: updated regulatory positions and pre- and post-marketing evidence. Expert Opin Biol Ther. 2018 Mar;18(3):309-15. PubMed: PM29186988
  • Tuffaha HW, Scuffham PA. The Australian Managed Entry Scheme: Are We Getting it Right? Pharmacoeconomics.2018 May;36(5):555-65. PubMed: PM29478116