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Suggested Citation:"Appendix A: Bibliography." National Academies of Sciences, Engineering, and Medicine. 2016. Advancing the Discipline of Regulatory Science for Medical Product Development: An Update on Progress and a Forward-Looking Agenda: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/23438.
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Appendix A

Bibliography
1

Adamo, J. E., E. E. Wilhelm, and S. J. Steele. 2015. Advancing a vision for regulatory science training. Clinical and Translational Science 8(5):615–618.

Ades, A. E., G. Lu, and K. Claxton. 2004. Expected value of sample information calculations in medical decision modeling. Medical Decision Making 24(2):207–227.

Anderson, A., and M. S. Cohen. 2013. Reducing clinical trial costs by detecting and measuring the placebo effect and treatment effect using brain imaging. Studies in Health Technology and Informatics 184:6–12.

Claxton, K. 1999. Bayesian approaches to the value of information: Implications for the regulation of new pharmaceuticals. Health Economics 8:269–274.

Cragin, M. H., P. B. Heidron, C. L. Palmer, and L. C. Smith. 2007. An educational program on data curation, presented at the American Library Association Science & Technology Section Conference, June 25, 2007, Washington, DC.

FDA (U.S. Food and Drug Administration). 2004. Innovation or stagnation: Challenge and opportunity on the critical path to new medical products. http://www.fda.gov/ScienceResearch/SpecialTopics/CriticalPathInitiative/CriticalPathOpportunitiesReports/ucm077262.htm (accessed May 17, 2016).

FDA Science Board. 2007. FDA science and mission at risk: Report of the Subcommittee on Science and Technology. http://www.fda.gov/ohrms/dockets/ac/07/briefing/20074329b_02_01_FDA%20Report%20on%20Science%20and%20Technology.pdf (accessed May 17, 2016).

FDA Science Board. 2015. Mission possible: How FDA can move at the speed of science: Report of the Science Looking Forward Subcommittee. http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/UCM463328.pdf (accessed May 17, 2016).

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1 This bibliography contains resources provided during presentations by workshop speakers, but not necessarily cited in the workshop summary report. These resources are included here as additional direction for readers interested in further exploration of the topics discussed at the workshop.

Suggested Citation:"Appendix A: Bibliography." National Academies of Sciences, Engineering, and Medicine. 2016. Advancing the Discipline of Regulatory Science for Medical Product Development: An Update on Progress and a Forward-Looking Agenda: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/23438.
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Fields, O. F. 2013. Perspectives on an alternative career path in regulatory science. Molecular Biology of the Cell 24:2157–2159.

IOM (Institute of Medicine). 2011. Building a national framework for the establishment of regulatory science for drug development: Workshop summary. Washington, DC: The National Academies Press.

IOM. 2012. Strengthening a workforce for innovative regulatory science in therapeutics development: Workshop summary. Washington, DC: The National Academies Press.

Leoutsakos, J. M., B. O. Muthen, J. C. Breitner, C. G. Lyketsos, and A. R. Team. 2012. Effects of non-steroidal anti-inflammatory drug treatments on cognitive decline vary by phase of pre-clinical Alzheimer disease: Findings from the randomized controlled Alzheimer’s Disease Anti-Inflammatory Prevention Trial. International Journal of Geriatric Psychiatry 27(4):364–374.

Muthen, B., and T. Asparouhov. 2014. Growth mixture modeling with non-normal distributions. Statistics in Medicine 34(6):1041–1058.

Muthen, B., and H. C. Brown. 2009. Estimating drug effects in the presence of placebo response: Causal inference using growth mixture modeling. Statistics in Medicine 28(27):3363–3385.

Pew Center for Research. 2015. Health fact sheet. http://www.pewinternet.org/fact-sheets/health-fact-sheet (accessed February 9, 2016).

Sentinel Program Interim Assessment (FY15). 2015. http://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM464043.pdf (accessed May 17, 2016).

Suggested Citation:"Appendix A: Bibliography." National Academies of Sciences, Engineering, and Medicine. 2016. Advancing the Discipline of Regulatory Science for Medical Product Development: An Update on Progress and a Forward-Looking Agenda: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/23438.
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Page 47
Suggested Citation:"Appendix A: Bibliography." National Academies of Sciences, Engineering, and Medicine. 2016. Advancing the Discipline of Regulatory Science for Medical Product Development: An Update on Progress and a Forward-Looking Agenda: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/23438.
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The field of endeavors known as "regulatory science" has grown out of the need to link and integrate knowledge within and among basic science research, clinical research, clinical medicine, and other specific scientific disciplines whose focus, aggregation, and ultimate implementation could inform biomedical product development and regulatory decision making. Substantial efforts have been devoted to defining regulatory science and communicating its value and role across the scientific and regulatory ecosystems. Investments are also being made in technology infrastructure, regulatory systems, and workforce development to support and advance this burgeoning discipline.

In October 2015, the National Academies of Sciences, Engineering, and Medicine held a public workshop to facilitate dialogue among stakeholders about the current state and scope of regulatory science, opportunities to address barriers to the discipline's success, and avenues for fostering collaboration across sectors. Participants explored key needs for strengthening the discipline of regulatory science, including considering what are the core components of regulatory science infrastructure to foster innovation in medical product development. This report summarizes the presentations and discussions from the workshop.

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