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Suggested Citation:"Appendix A: References." National Academies of Sciences, Engineering, and Medicine. 2021. Drug Research and Development for Adults Across the Older Age Span: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25998.
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Suggested Citation:"Appendix A: References." National Academies of Sciences, Engineering, and Medicine. 2021. Drug Research and Development for Adults Across the Older Age Span: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25998.
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Page 74
Suggested Citation:"Appendix A: References." National Academies of Sciences, Engineering, and Medicine. 2021. Drug Research and Development for Adults Across the Older Age Span: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25998.
×
Page 75
Suggested Citation:"Appendix A: References." National Academies of Sciences, Engineering, and Medicine. 2021. Drug Research and Development for Adults Across the Older Age Span: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25998.
×
Page 76
Suggested Citation:"Appendix A: References." National Academies of Sciences, Engineering, and Medicine. 2021. Drug Research and Development for Adults Across the Older Age Span: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25998.
×
Page 77
Suggested Citation:"Appendix A: References." National Academies of Sciences, Engineering, and Medicine. 2021. Drug Research and Development for Adults Across the Older Age Span: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25998.
×
Page 78

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Appendix A References Abbasi, J. 2019. Older patients (still) left out of cancer clinical trials. JAMA 322(18):1751-1753. Akpan, A., C. Roberts, K. Bandeen-Roche, B. Batty, C. Bausewein, D. Bell, D. Bramley, J. Bynum, I. D. Cameron, L. K. Chen, A. Ekdahl, A. Fertig, T. Gentry, M. Harkes, D. Haslehurst, J. Hope, D. R. Hurtado, H. Lyndon, J. Lynn, M. Martin, R. Isden, F. M. Raso, S. Shaibu, J. Shand, C. Sherrington, S. Sinha, G. Turner, N. De Vries, G. J. Yi, J. Young, and J. Banerjee. 2018. Standard set of health outcome measures for older persons. BMC Geriatrics 18(1):36. Alvis, B. D., and C. G. Hughes. 2015. Physiology considerations in the geriatric patient. Anesthesiology Clinics 33(3):447-456. Anderson, M. 2019. Mobile technology and home broadband 2019. Pew Research Center. https://www.pewresearch.org/internet/2019/06/13/mobile-technology-and-home-broadband-2019 (accessed November 12, 2020). Anderson, M., and A. Perrin. 2017. Tech adoption climbs among older adults. Pew Research Center. https://www.pewresearch.org/internet/2017/05/17/tech-adoption-climbs-among-older-adults (accessed November 12, 2020). Anderson, A., D. Borfitz, and K. Getz. 2018. Global public attitudes about clinical research and patient experiences with clinical trials. JAMA Network Open 1(6):e182969. Angus, D. C. 2015. Fusing randomized trials with big data: The key to self-learning health care systems? JAMA 314(8):767-768. Angus, D. C., B. M. Alexander, S. Berry, M. Buxton, R. Lewis, M. Paoloni, S. A. R. Webb, S. Arnold, A. Barker, D. A. Berry, M. J. M. Bonten, M. Brophy, C. Butler, T. F. Cloughesy, L. P. G. Derde, L. J. Esserman, R. Ferguson, L. Fiore, S. C. Gaffey, J. M. Gaziano, K. Giusti, H. Goossens, S. Heritier, B. Hyman, M. Krams, K. Larholt, L. M. LaVange, P. Lavori, A. W. Lo, A. J. London, V. Manax, C. McArthur, G. O’Neill, G. Parmigiani, J. Perlmutter, E. A. Petzold, C. Ritchie, K. M. Rowan, C. W. Seymour, N. I. Shapiro, D. M. Simeone, B. Smith, B. Spellberg, A. D. Stern, L. Trippa, M. Trusheim, K. Viele, P. Y. Wen, and J. Woodcock. 2019. Adaptive platform trials: Definition, design, conduct and reporting considerations. Nature Reviews Drug Discovery 18:797-807. Bai, J. P. F., G. J. Burckart, and A. E. Mulberg. 2016. Literature review of gastrointestinal physiology in the elderly, in pediatric patients, and in patients with gastrointestinal diseases. Journal of Pharmaceutical Sciences 105(2):476-483. Balls-Berry, J., L. C. Dacy, and J. Balls. 2015. “Heard it through the grapevine”: The Black barbershop as a source of health information. Hektoen International 7(3). Beck, C. A., D. B. Beran, K. M. Biglan, C. M. Boyd, E. R. Dorsey, P. N. Schmidt, R. Simone, A. W. Willis, N. B. Galifianakis, M. Katz, C. M. Tanner, K. Dodenhoff, J. Aldred, J. Carter, A. Fraser, J. Jimenez-Shahed, C. Hunter, M. Spindler, S. Reichwein, Z. Mari, B. Dunlop, J. C. Morgan, D. McLane, P. Hickey, L. Gauger, I. H. Richard, N. I. Mejia, G. Bwala, M. Nance, L. C. Shih, C. Singer, S. Vargas-Parra, C. Zadikoff, N. Okon, A. Feigin, J. Ayan, C. Vaughan, R. Pahwa, R. Dhall, A. Hassan, S. DeMello, S. S. Riggare, P. Wicks, M. A. Achey, M. J. Elson, S. Goldenthal, H. T. Keenan, R. Korn, H. Schwarz, S. Sharma, E. A. Stevenson, and W. Zhu. 2017. National randomized controlled trial of virtual house calls for Parkinson disease. Neurology 89(11):1152-1161. Benjamin, E. J., M. J. Blaha, S. E. Chiuve, M. Cushman, S. R. Das, R. Deo, S. D. de Ferranti, J. Floyd, M. Fornage, C. Gillespie, C. R. Isasi, M. C. Jiménez, L. Chaffin Jordan, S. E. Judd, D. Lackland, J. H. Lichtman, L. Lisabeth, S. Liu, C. T. Longenecker, R. H. Mackey, K. Matsushita, D. Mozaffarian, M. E. Mussolino, K. Nasir, R. W. Neumar, L. Palaniappan, D. K. Pandey, R. R. Thiagarajan, M. J. Reeves, M. Ritchey, C. J. Rodriguez, G. A. Roth, W. D. Rosamond, C. Sasson, A. Towfighi, C. W. PREPUBLICATION COPY: UNCORRECTED PROOFS A-1

A-2 DRUG R&D FOR ADULTS ACROSS THE OLDER AGE SPAN Tsao, M. B. Turner, S. S. Virani, J. H. Voeks, J. Z. Willey, J. T. Wilkins, J. H. Wu, H. M. Alger, S. S. Wong, and P. Muntner. 2017. Heart disease and stroke statistics—2017 update: A report from the American Heart Association. Circulation 135:e146-e603. Berenbrok, L. A., N. Gabriel, K. C. Coley, and I. Hernandez. 2020. Evaluation of frequency of encounters with primary care physicians vs. visits to community pharmacies among Medicare beneficiaries. JAMA Network Open 3(7):e209132. Bernard, M. A., J. A. Clayton, and M. S. Lauer. 2018. Inclusion across the lifespan: NIH policy for clinical research. JAMA 320(15):1535-1536. Bloch, F., and N. Charasz. 2014. Attitudes of older adults to their participation in clinical trials: A pilot study. Drugs Aging 31:373-377. Bourgeois, F. T., L. Orenstein, S. Ballakur, K. D. Mandl, and J. P. A. Ioannidis. 2017. Exclusion of elderly people from randomized clinical trials of drugs for ischemic heart disease. Journal of the American Geriatrics Society 65(11):2354-2361. Brandt, H. M., V. M. Young, D. A. Campbell, S. K. Choi, J. S. Seel, and D. B. Friedman. 2015. Federally Qualified Health Centers’ capacity and readiness for research collaborations: Implications for clinical–academic–community partnerships. Clinical and Translational Science 8(4):391-393. BrintzenhofeSzoc, K., J. I. Krok-Schoen, J. L. Pisegna, A. R. MacKenzie, B. Canin, E. Plotkin, L. M. Boehmer, and A. Shahrokni. 2020. Survey of cancer care providers’ attitude toward care of older adults with cancer during the COVID-19 pandemic. Journal of Geriatric Oncology. Epub ahead of print. Bushardt, R. L., E. B. Massey, T. W. Simpson, J. C. Ariail, and K. N. Simpson. 2008. Polypharmacy: Misleading, but manageable. Clinical Interventions in Aging 3(2):383-389. Challa, H. J., M. A. Ameer, and K. R. Uppaluri. 2020. DASH diet to stop hypertension. Treasure Island, FL: StatPearls Publishing. Chapman, J. E., D. A. Cadilhac, B. Gardner, J. Ponsford, R. Bhalla, and R. J. Stolwyk. 2019. Comparing face-to-face and videoconference completion of the Montreal Cognitive Assessment (MoCA) in community-based survivors of stroke. Journal of Telemedicine and Telecare. Epub ahead of print. Comis, R. L., J. D. Miller, D. D. Colaizzi, and L. G. Kimmel. 2009. Physician-related factors involved in patient decisions to enroll onto cancer clinical trials. Journal of Oncology Practice 5(2):50-56. Curran, G. M., M. Bauer, B. Mittman, J. M. Pyne, and C. Stetler. 2012. Effectiveness- implementation hybrid designs: Combining elements of clinical effectiveness and implementation research to enhance public health impact. Medical Care 50(3):217-226. Dellson, P., K. Nilsson, H. Jernström, and C. Carlsson. 2018. Patients’ reasoning regarding the decision to participate in clinical cancer trials: An interview study. Trials 19:528. DeYoung, N., and B. V. Shenal. 2019. The reliability of the Montreal Cognitive Assessment using telehealth in a rural setting with veterans. Journal of Telemedicine and Telecare 25(4):197-203. Dhruva, S. S., and R. F. Redberg. 2008. Variations between clinical trial participants and Medicare beneficiaries in evidence used for Medicare national coverage decisions. Archives of Internal Medicine 168(2):136-140. Dresser, R. 1992. Wanted. Single, white male for medical research. Hastings Center Report 22(1):24-29. Elkin-Frankston, S. 2017. Cognitive Assessment and Monitoring Platform for Integrative Research (CAMPFIRE). https://www.cra.com/publications/2017elkinfrankston2 (accessed November 12, 2020). Ernst, F. R., and A. J. Grizzle. 2001. Drug-related morbidity and mortality: Updating the cost-of-illness model. Journal of the American Pharmaceutical Association 41(2):192-199. FDA (U.S. Food and Drug Administration). 2020. New drug therapy approvals 2019. https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic- biological-products/novel-drug-approvals-2019 (accessed November 12, 2020). PREPUBLICATION COPY: UNCORRECTED PROOFS

REFERENCES A-3 Fialová, D., I. Kummer, M. Držaić, and M. Leppee. 2018. Ageism in medication use in older patients. In L. Ayalon and C. Tesch-Römer (eds.), Contemporary Perspectives on Ageism. International Perspectives on Aging, vol 19. Springer, Cham. Fiscella, K., G. Ogedegbe, H. He, J. Carroll, A. Cassells, M. Sanders, C. Khalida, B. D’Orazio, and J. N. Tobin. 2015. Blood pressure visit intensification study in treatment: Trial design. American Heart Journal 170(6):1202-1210. Fiscella, K., M. Sanders, T. Holder, J. K. Carroll, A. Luque, A. Cassells, B. A. Johnson, S. K. Williams, and J. N. Tobin. 2020. The role of data and safety monitoring boards in implementation trials: When are they justified? Journal of Clinical and Translational Science 4(3):229-232. Fulmer, T., K. S. Mate, and A. Berman. 2018. The age-friendly health system imperative. Journal of the American Geriatrics Society 66(1):22-24. Gore, L., S. P. Ivy, F. M. Balis, E. Rubin, K. Thornton, M. Donoghue, S. Roberts, S. Bruinooge, J. Ersek, N. Goodman, C. Schenkel, and G. Reaman. 2017. Modernizing clinical trial eligibility: Recommendations of the American Society of Clinical Oncology–Friends of Cancer Research Minimum Age Working Group. Journal of Clinical Oncology 35(33):3781-3787. Grandison, M. K., and F. D. Boudinot. 2000. Age-related changes in protein binding of drugs: Implications for therapy. Clinical Pharmacokinetics 38(3):271-279. Gurwitz, J. 2014. The Exclusion of Older People from Participation in Cardiovascular Trials. Virtual Mentor 16(5):365-368. Heitkemper, E. M., L. Mamykina, J. N. Tobin, A. Cassells, and A. Smaldone. 2017. Baseline characteristics and technology training of underserved adults with type 2 diabetes in the Mobile Diabetes Detective (MoDD) randomized controlled trial. Diabetes Educator 43(6):576-588. Helfand, B. K., M. Webb, S. L. Gartaganis, L. Fuller, C. Kwon, and S. K. Inouye. 2020. The exclusion of older persons from vaccine and treatment trials for coronavirus disease 2019—missing the target. JAMA Internal Medicine 180(11):1546-1549. Herrera, A. P., S. A. Snipes, D. W. King, I. Torres-Vigil, D. S. Goldberg, and A. D. Weinberg. 2010. Disparate inclusion of older adults in clinical trials: Priorities and opportunities for policy and practice change. American Journal of Public Health 100(S1):S105-S112. Hilmer, S. N., H. Wu, and M. Zhang. 2019. Biology of frailty: Implications for clinical pharmacology and drug therapy in frail older people. Mechanisms of Ageing and Development 181:22-28. IOM (Institute of Medicine). 1997. Pharmacokinetics and drug interactions in the elderly and special issues in elderly African-American populations: Workshop summary. Washington, DC: National Academy Press. Jacobs, P., D. Anello, and S. Elkin-Frankston. 2019. Using design to connect patients, providers, and researchers: A Cognitive Assessment and Monitoring Platform for Integrative Research (CAMPFIRE). In Advances in human factors and ergonomics in healthcare and medical devices, edited by N. Lightner. AHFE 2018. Advances in Intelligent Systems and Computing, vol. 779. Springer, Cham. Joinson, A. 2001. Self-disclosure in computer-mediated communication: The role of self-awareness and visual anonymity. European Journal of Social Psychology 31:177-192. Karlawish, J., M. S. Cary, J. Rubright, and T. Tenhave. 2008. How redesigning AD clinical trials might increase study partners’ willingness to participate. Neurology 71(23):1883-1888. Kuehn, B. M. 2006. Industry, FDA warm to “adaptive” trials. JAMA 296(16):1955-1957. Kluger, B. M., J. Miyasaki, M. Katz, N. Galifianakis, K. Hall, S. Pantilat, R. Khan, C. Friedman, W. Cernik, Y. Goto, J. Long, D. Fairclough, S. Sillau, and J. S. Kutner. 2020. Comparison of integrated outpatient palliative care with standard care in patients with Parkinson disease and related disorders: A randomized clinical trial. JAMA Neurology 77(5):551-560. Lam, J. R., J. L. Schneider, W. Zhao, and D. A. Corley. 2013. Proton pump inhibitor and histamine 2 receptor antagonist use and vitamin B12 deficiency. JAMA 310(22):2435-2442. PREPUBLICATION COPY: UNCORRECTED PROOFS

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There is a void in evidence-based information for making informed decisions on how to optimize care for older adults, particularly those 80 years and over. Because older adults are vastly underrepresented in clinical trials, there is a dearth of information about the appropriate use of drugs in this population. Yet older adults have higher rates of comorbidities and simultaneous use of multiple medications than the general population, and are the majority users of many medications. Additionally, age-related physiological and pathological changes, particularly for adults 80 years of age and older, can lead to significant differences in the pharmacokinetics (PK)2 and pharmacodynamics (PD)3 of a given drug compared to the general population.

On August 5 and 6, 2020, the National Academies of Sciences, Engineering, and Medicine hosted a workshop titled Drug Research and Development for Adults Across the Older Age Span. The workshop was designed to examine the challenges and opportunities in drug research and development for older adult populations, explore barriers that impede safety and efficacy studies in these populations, and share lessons learned for better understanding clinical pharmacology for populations over age 65. This publication summarizes the presentation and discussion of the workshop.

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