Technical Review of Clinical Outcomes Assessments Across the Continuum of Alzheimer's Disease

Author:

DiBenedetti Dana B.,Menne Heather,Paulsen Russ,Krasa Holly B.,Vradenburg George,Comer Meryl,Callahan Leigh F.,Winfield John,Potashman Michele,Heithoff Kim,Hartry Ann,Oberdhan Dorothee,Wilson Hilary,Hoffman Deborah L.,Wieberg Dan,Kremer Ian N.,Taylor Geraldine A.,Taylor James M.,Lappin Debra,Martin Allison D.,Hauber Brett,Romano Carla

Funder

AD PACE

Publisher

Springer Science and Business Media LLC

Subject

Neurology (clinical),Neurology

Reference31 articles.

1. DiBenedetti D, Slota C, Wronski SL, Vradenburg G, Comer M, Callahan LF, et al. Assessing what matters most to patients with or at risk for Alzheimer’s and care partners: a qualitative study evaluating symptoms, impacts, and outcomes. Alzheimers Res Ther. 2020;12(1):90.

2. Hauber et al. Assessing what matters to people affected by alzheimer’s disease: a quantitative analysis (forthcoming).

3. Jutten RJ, Papp KV, Hendrix S, Ellison N, Langbaum JB, Donohue MC, et al. Why a clinical trial is as good as its outcome measure: A framework for the selection and use of cognitive outcome measures for clinical trials of Alzheimer's disease. Alzheimers Dement. 2022. https://doi.org/10.1002/alz.12773.

4. US Food and Drug Administration. Guidance for industry patient-reported outcome measures: use in medical product development to support labeling claims. 2009. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM193282.pdf. Accessed 31 Mar 2022.

5. US Food and Drug Administration. Patient-focused drug development guidance public workshop: Methods to identify what is important to patients & select, develop or modify fit for purpose clinical outcomes assessments. 2018. https://www.fda.gov/media/116281/download. Accessed 31 Mar 2022.

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