Skip to main content Accessibility help
×
Hostname: page-component-5d59c44645-mrcq8 Total loading time: 0 Render date: 2024-02-29T05:59:36.830Z Has data issue: false hasContentIssue false

Section 5 - Academic Drug-Development Programs

Published online by Cambridge University Press:  03 March 2022

Jeffrey Cummings
Affiliation:
University of Nevada, Las Vegas
Jefferson Kinney
Affiliation:
University of Nevada, Las Vegas
Howard Fillit
Affiliation:
Alzheimer’s Drug Discovery Foundation
Get access

Summary

Image of the first page of this content. For PDF version, please use the ‘Save PDF’ preceeding this image.'
Type
Chapter
Information
Alzheimer's Disease Drug Development
Research and Development Ecosystem
, pp. 429 - 454
Publisher: Cambridge University Press
Print publication year: 2022

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

References

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: www.icmje.org/recommendations/browse/roles-and-responsibilities/author-responsibilities--conflicts-of-interest.html (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

References

PhRMA Foundation. Biopharmaceutical research and development: the process behind new medicines. 2015. Available at: www.phrma.org/-/media/Project/PhRMA/PhRMA-Org/PhRMA-Org/PDF/P-R/rd_brochure.pdf (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

Save book to Kindle

To save this book to your Kindle, first ensure coreplatform@cambridge.org is added to your Approved Personal Document E-mail List under your Personal Document Settings on the Manage Your Content and Devices page of your Amazon account. Then enter the ‘name’ part of your Kindle email address below. Find out more about saving to your Kindle.

Note you can select to save to either the @free.kindle.com or @kindle.com variations. ‘@free.kindle.com’ emails are free but can only be saved to your device when it is connected to wi-fi. ‘@kindle.com’ emails can be delivered even when you are not connected to wi-fi, but note that service fees apply.

Find out more about the Kindle Personal Document Service.

Available formats
×

Save book to Dropbox

To save content items to your account, please confirm that you agree to abide by our usage policies. If this is the first time you use this feature, you will be asked to authorise Cambridge Core to connect with your account. Find out more about saving content to Dropbox.

Available formats
×

Save book to Google Drive

To save content items to your account, please confirm that you agree to abide by our usage policies. If this is the first time you use this feature, you will be asked to authorise Cambridge Core to connect with your account. Find out more about saving content to Google Drive.

Available formats
×