Agency
National Institute of Health (NIH)
Institute
Food and Drug Administration (FDA)
Type
Research Project--Cooperative Agreements (U01)
Project #
3U01FD003865-04S1
Application #
8550899
Study Section
Special Emphasis Panel (ZFD1-SRC (99))
Project Start
2009-09-20
Project End
2014-08-31
Budget Start
2012-09-01
Budget End
2013-08-31
Support Year
4
Fiscal Year
2012
Total Cost
Indirect Cost
Name
Critical Path Institute
Department
Type
DUNS #
175893135
City
Tucson
State
AZ
Country
United States
Zip Code
85718
Taylor, Fiona; Reasner, David S; Carson, Robyn T et al. (2016) Development of a Symptom-Based Patient-Reported Outcome Instrument for Functional Dyspepsia: A Preliminary Conceptual Model and an Evaluation of the Adequacy of Existing Instruments. Patient 9:409-18
Hill, Derek L G; Schwarz, Adam J; Isaac, Maria et al. (2014) Coalition Against Major Diseases/European Medicines Agency biomarker qualification of hippocampal volume for enrichment of clinical trials in predementia stages of Alzheimer's disease. Alzheimers Dement 10:421-9.e3
Yu, Peng; Sun, Jia; Wolz, Robin et al. (2014) Operationalizing hippocampal volume as an enrichment biomarker for amnestic mild cognitive impairment trials: effect of algorithm, test-retest variability, and cut point on trial cost, duration, and sample size. Neurobiol Aging 35:808-18
Coons, Stephen Joel (2013) ePRO systems validation: clearly defining the roles of clinical trial teams and ePRO system providers. Value Health 16:457-8
Perrone, Ronald D; Coons, Stephen Joel; Cavanaugh, Kerri et al. (2013) Patient-reported outcomes in clinical trials of CKD-related therapies: report of a symposium sponsored by the national kidney foundation and the U.S. Food and Drug Administration. Am J Kidney Dis 62:1046-57
Rogers, James A; Polhamus, Daniel; Gillespie, William R et al. (2012) Combining patient-level and summary-level data for Alzheimer's disease modeling and simulation: a β regression meta-analysis. J Pharmacokinet Pharmacodyn 39:479-98
Coons, S J; Kothari, S; Monz, B U et al. (2011) The patient-reported outcome (PRO) consortium: filling measurement gaps for PRO end points to support labeling claims. Clin Pharmacol Ther 90:743-8