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A Related Resources The references listed below are papers, projects, and guidance documents that supported the planning of and discussions during each workshop in this series. References are separated by relevance to each of the three workshops, and the Proceedingsâin Brief from workshops 1 and 2 produced by the National Academies of Sciences, Engineering, and Medicine as part of this activity are included as well. These references are intended to provide readers and real-world evidence stakeholders with additional context for the discussions that occurred during the workshops. Workshop 1: Incentives Berger, M., G. Daniel, K. Frank, A. Hernandez, M. McClellan, S. Okun, M. Overhage, R. Platt, M. Romine, S. Tunius, and M. Wilson. 2017. A framework for regulatory use of real-world evidence. Washington, DC: Duke-Margolis Center for Health Policy. CDRH (Center for Devices and Radiological Health). 2017. Use of real-world evidence to support regulatory decision-making for medical devices: Guidance for industry and Food and Drug Administration staff. Rockville, MD: U.S. Food and Drug Administration. CTTI (Clinical Trials Transformation Initiative). 2018. Project: Quality by Design. https://www.ctti-clinicaltrials.org/projects/quality-design (accessed November 6, 2018). CTTI. 2018. Project: Real World Evidence. https://www.ctti-clinicaltrials.org/projects/real- world-evidence (accessed November 6, 2018). NASEM (National Academies of Sciences, Engineering, and Medicine). 2017. Real-world evidence generation and evaluation of therapeutics: Proceedings of a workshop. Washington, DC: The National Academies Press. doi: https://doi.org/10.17226/24685. NASEM. 2018. Examining the impact of real-world evidence on medical product development: I. Incentives: Proceedings of a workshopâin brief. Washington, DC: The National Academies Press. doi: https://doi.org/10.17226/25024. National Health Council. 2017. Patient perspectives on real-world evidence: A roundtable to gather views, needs, and recommendations. Washington, DC: National Health Council. Sherman, R. E., S. A. Anderson, G. J. Dal Pan, G. W. Gray, T. Gross, N. L. Hunter, L. LaVange, D. Marinac-Dabic, P. W. Marks, M. A. Robb, J. Shuren, R. Temple, J. Woodcock, L. Q. Yue, and R. M. Califf. 2016. Real-world evidenceâwhat is it and what can it tell us? New England Journal of Medicine 375(23):2293-2297. P REP UBLI CATI ON COP Y: UNCORR ECTED P ROOFS 145
146 EXAMINING THE IMPACT OF RWE ON MEDICAL PRODUCT DEVELOPMENT Workshop 2: Practical Approaches NASEM (National Academies of Sciences, Engineering, and Medicine). 2018. Examining the impact of real-world evidence on medical product development: II. Practical approaches: Proceedings of a workshopâin brief. Washington, DC: The National Academies Press. doi: https://doi.org/10.17226/25176. Workshop 3: Application CTTI. (Clinical Trials Transformation Initiative) 2018. Project: Mobile Technologies. https://www.ctti-clinicaltrials.org/projects/mobile-technologies (accessed November 6, 2018). Daniel, G., C. Silcox, J. Bryan, M. McClellan, M. Romine, and K. Frank. 2018. Characterizing RWD quality and relevancy for regulatory purposes. Washington, DC: Duke-Margolis Center for Health Policy. FDA (U.S. Food and Drug Administration). 2013. Guidance for industry and FDA staff: Best practices for conducting and reporting pharmacoepidemiologic safety studies using electronic healthcare data. Rockville, MD: FDA. FDA. 2013. Guidance for industry: Electronic source data in clinical investigations. Rockville, MD: FDA. FDA. 2016. Use of electronic informed consentâquestions and answers: Guidance for institutional review boards, investigators, and sponsors. Rockville, MD: FDA. FDA. 2018. Use of electronic health record data in clinical investigations: Guidance for industry. Rockville, MD: FDA. FOCR (Friends of Cancer Research). 2018. Establishing a framework to evaluate real-world endpoints. Washington, DC: Friends of Cancer Research. Innovative Medicines Initiative GetReal. 2018. Deliverables. http://www.imi- getreal.eu/Publications/Deliverables-and-reports (accessed November 6, 2018). Izurieta, H. S., M. Wernecke, J. Kelman, S. Wong, R. Forshee, D. Pratt, Y. Lu, Q. Sun, C. Jankosky, P. Krause, C. Worrall, T. MaCurdy, and R. Harpaz. 2017. Effectiveness and duration of protection provided by the live-attenuated herpes zoster vaccines in the Medicare population ages 65 years and older. Clinical Infectious Diseases 64(6):785-793. Kimmelman, J., and A. J. London. 2015. The structure of clinical translation: Efficiency, information, and ethics. Hastings Center Report 45(2):27-39. U.K. Academy of Medical Sciences and the Association of the British Pharmaceutical Industry. 2015. Real world evidence. London, England: U.K. Academy of Medical Sciences and the Association of the British Pharmaceutical Industry. U.K. Academy of Medical Sciences FORUM. 2018. Next steps for using real world evidence. London, England: U.K. Academy of Medical Sciences. P REP UBLI CATI ON COP Y: UNCORR ECTED P ROOFS