Agency
National Institute of Health (NIH)
Institute
Food and Drug Administration (FDA)
Type
Research Project--Cooperative Agreements (U01)
Project #
5U01FD003865-03
Application #
8138011
Study Section
Special Emphasis Panel (ZFD1-SRC (99))
Project Start
2009-09-20
Project End
2014-08-31
Budget Start
2011-09-01
Budget End
2012-08-31
Support Year
3
Fiscal Year
2011
Total Cost
Indirect Cost
Name
Critical Path Institute
Department
Type
DUNS #
175893135
City
Tucson
State
AZ
Country
United States
Zip Code
85718
Arneri?, Stephen P; Batrla-Utermann, Richard; Beckett, Laurel et al. (2017) Cerebrospinal Fluid Biomarkers for Alzheimer's Disease: A View of the Regulatory Science Qualification Landscape from the Coalition Against Major Diseases CSF Biomarker Team. J Alzheimers Dis 55:19-35
Dunn, Michael E; Manfredi, Thomas G; Agostinucci, Kevin et al. (2017) Serum Natriuretic Peptides as Differential Biomarkers Allowing for the Distinction between Physiologic and Pathologic Left Ventricular Hypertrophy. Toxicol Pathol 45:344-352
McCarrier, Kelly P; Atkinson, Thomas M; DeBusk, Kendra P A et al. (2016) Qualitative Development and Content Validity of the Non-small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ), A Patient-reported Outcome Instrument. Clin Ther 38:794-810
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
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
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 10:421-429.e3
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 ? 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