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Section 5 - Academic Drug-Development Programs

Published online by Cambridge University Press:  03 March 2022

Jeffrey Cummings
University of Nevada, Las Vegas
Jefferson Kinney
University of Nevada, Las Vegas
Howard Fillit
Alzheimer’s Drug Discovery Foundation
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Alzheimer's Disease Drug Development
Research and Development Ecosystem
, pp. 429 - 454
Publisher: Cambridge University Press
Print publication year: 2022

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Largent, EA, Joffe, S, Miller, FG. Can research and care be ethically integrated? Hastings Cent Rep 2011; 41: 3746.CrossRefGoogle ScholarPubMed
Emanuel, EJ, Wendler, D, Grady, C. What makes clinical research ethical? JAMA 2000; 283: 2701–11.Google Scholar
Grady, C. Institutional review boards: purposes and challenges. Chest 2015; 148: 1148–55.Google Scholar
Silverman, H, Hull, SC, Sugarman, J. Variability among institutional review boards’ decisions within the context of a multicenter trial. Crit Care Med 2001; 29: 235–41.CrossRefGoogle ScholarPubMed
Hirshon, JM. Variability in institutional review board assessment of minimal-risk research. Acad Emerg Med 2002; 9: 1417–20.Google Scholar
Cummings, J, Aisen, PS, DuBois, B, et al. Drug development in Alzheimer’s disease: the path to 2025. Alzheimers Res Ther 2016; 8: 39.CrossRefGoogle ScholarPubMed
Fost, N, Levine, RJ. The dysregulation of human subjects research. JAMA 2007; 298: 2196.Google Scholar
Lynch, HF, Rosenfeld, S. Institutional review board quality, private equity, and promoting ethical human subjects research. Ann Intern Med 2020; 173: 558–62.Google Scholar
Emanuel, EJ, Lemmens, T, Elliot, C. Should society allow research ethics boards to be run as for-profit enterprises? PLoS Med 2006; 3: e309.Google Scholar
Lemmens, T, Freedman, B. Ethics review for sale? Conflict of interest and commercial research review boards. Milbank Q 2000; 78: 547–84.CrossRefGoogle ScholarPubMed
Klitzman, R. Institutional review board community members: who are they, what do they do, and whom do they represent? Acad Med 2012; 87: 975–81.CrossRefGoogle Scholar
Grady, C. Do IRBs protect human research participants? JAMA 2010; 304: 11223.CrossRefGoogle ScholarPubMed
Gunsalus, CK. Mission Creep in the IRB World. Science 2006; 312: 1441.CrossRefGoogle ScholarPubMed
Lynch, HF, Nicholls, SG, Meyer, M, Taylor, HA. Of parachutes and participant protection: moving beyond quality to advance effective research ethics oversight. J Empir Res Hum Res Ethics 2019; 14 :190–6.CrossRefGoogle ScholarPubMed
Tsan, M-F. Measuring the quality and performance of institutional review boards. J Empir Res Hum Res Ethics 2019; 14: 187–9.CrossRefGoogle ScholarPubMed
McCoy, MS, Emanuel, EJ. Why there are no “potential” conflicts of interest. JAMA 2017; 317: 1721–2.Google Scholar
Cho, MK, Ryo, S, Schissel, A, Drummond, R. Policies on faculty conflicts of interest at US universities. JAMA 2000; 284: 2203.Google Scholar
Ahn, R, Woodbridge, A, Abraham, A, et al. Financial ties of principal investigators and randomized controlled trial outcomes: cross sectional study. BMJ 2017; 356: i6770.CrossRefGoogle ScholarPubMed
Institute of Medicine. Patient Outcomes Research Teams (PORTS): Managing Conflict of Interest. Washington, DC: The National Academies Press; 1981.Google Scholar
International Committe of Medical Journal Editors. Disclosure of financial and non-financial relationships and activities, and conflicts of interest. Available at: (accessed November 22, 2020).Google Scholar
Rockey, SJ. Managing financial conflict of interest in biomedical research. JAMA 2010; 303: 2400.Google Scholar
Morain, SR, Joffe, S, Campbell, EG, Mello, MM. Institutional oversight of faculty–industry consulting relationships in U.S. medical schools: a Delphi study. J Law Med Ethics 2015; 43: 383–96.Google Scholar
Mello, MM, Murtagh, L, Joffe, S. Beyond financial conflicts of interest: institutional oversight of faculty consulting agreements at schools of medicine and public health. PLoS One 2018; 13: e0203179.CrossRefGoogle ScholarPubMed
Ehringhaus, SH. Responses of medical schools to institutional conflicts of interest. JAMA 2008; 299: 665.Google Scholar
Campbell, EG, Weissman, JS, Vogeli, C. Financial relationships between institutional review board members and industry. N Engl J Med 2006; 355: 2321–9.Google Scholar
Bauchner, H, Fontanarosa, PB, Flanagin, A. Conflicts of interests, authors, and journals: new challenges for a persistent problem. JAMA 2018; 320: 2315.Google Scholar
Appelbaum, PS. Assessment of patients’ competence to consent to treatment. N Engl J Med 2007; 357: 1834–40.CrossRefGoogle ScholarPubMed
Jeste, DV, Palmer, BW, Appelbaum, PS. A new brief instrument for assessing decisional capacity for clinical research. Arch Gen Psychiatry 2007; 64: 966.CrossRefGoogle ScholarPubMed
Dunn, LB, Nowrangi, MA, Palmer, BW, Jeste, DV, Saks, ER. Assessing decisional capacity for clinical research or treatment: a review of instruments. Am J Psychiatry 2006; 163: 1323–34.Google Scholar
Keyserlingk, EW, Glass, K, Kogan, S, Gauthier, S. Proposed guidelines for the participation of persons with dementia as research subjects. Perspect Biol Med 1995; 38: 319–61.Google Scholar
Black, BS, Rabins, PV, Sugarman, J, Karlawish, JH. Seeking assent and respecting dissent in dementia research. Am J Geriatr Psychiatry 2010; 18: 7785.CrossRefGoogle ScholarPubMed
Karlawish, J. Research involving cognitively impaired adults. N Engl J Med 2003; 348: 1389–92.Google Scholar
Morain, SR, Joffe, S, Largent, EA. When is it ethical for physician-investigators to seek consent from their own patients? Am J Bioeth 2019; 19: 1118.Google Scholar
Cho, MK, Magnus, D, Constantine, M, et al. Attitudes toward risk and informed consent for research on medical practices: a cross-sectional survey. Ann Intern Med 2015; 162: 690.Google Scholar
Kelley, M, James, C, Kraft, SA, et al. Patient perspectives on the learning health system: the importance of trust and shared decision making. Am J Bioeth 2015; 15: 417.Google Scholar
Largent, EA, Karlawish, J. Rescuing research participants after Alzheimer trials stop early: sending out an SOS. JAMA Neurol 2020; 77: 413–14.Google Scholar
Pierce, AL, Cox, CG, Nguyen, HT, et al. Participant satisfaction with learning Alzheimer disease clinical trial results. Alzheimer Dis Assoc Disord 2018; 32: 366–8.Google Scholar


PhRMA Foundation. Biopharmaceutical research and development: the process behind new medicines. 2015. Available at: (accessed December 4, 2020).Google Scholar
Wouters, OJ, McKee, M, Luyten, J. Estimated research and development investment needed to bring a new medicine to market, 2009–2018. JAMA 2020; 323: 844–53.Google Scholar
DiMasi, JA, Grabowski, HG, Hansen, RW. Innovation in the pharmaceutical industry: new estimates of R&D costs. J Health Econ 2016; 47: 2033.Google Scholar
Wong, CH, Siah, KW, Lo, AW. Estimation of clinical trial success rates and related parameters. Biostatistics 2019; 20: 273–86.Google ScholarPubMed
Begley, CG, Ellis, LM. Raise standards for preclinical cancer research. Nature 2012; 483: 531–3.CrossRefGoogle ScholarPubMed
Schillebeeckx, M, Maricque, B, Lewis, C. The missing piece to changing the university culture. Nat Biotechnol 2013; 31: 938–41.Google Scholar
Salehi, A, Faizi, M, Colas, D, et al. Restoration of norepinephrine-modulated contextual memory in a mouse model of Down syndrome. Sci Transl Med 2009; 1: 7ra17.Google Scholar
Coutellier, L, Ardestani, PM, Shamloo, M. Β1-adrenergic receptor activation enhances memory in Alzheimer’s disease model. Ann Clin Transl Neurol 2014; 1: 348–60.Google Scholar
Ardestani, PM, Evans, AK, Yi, B, et al. Modulation of neuroinflammation and pathology in the 5×FAD mouse model of Alzheimer’s disease using a biased and selective beta-1 adrenergic receptor partial agonist. Neuropharmacology 2017; 116: 371–86.Google Scholar
Yi, B, Jahangir, A, Evans, AK, et al. Discovery of novel brain permeable and G protein-biased beta-1 adrenergic receptor partial agonists for the treatment of neurocognitive disorders. PloS One 2017; 12: e0180319.Google Scholar

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