Agency
National Institute of Health (NIH)
Institute
Food and Drug Administration (FDA)
Type
Research Demonstration--Cooperative Agreements (U18)
Project #
5U18FD005320-02
Application #
8921965
Study Section
Special Emphasis Panel (ZFD1)
Project Start
2014-09-05
Project End
2019-08-31
Budget Start
2015-09-01
Budget End
2016-08-31
Support Year
2
Fiscal Year
2015
Total Cost
Indirect Cost
Name
Critical Path Institute
Department
Type
DUNS #
175893135
City
Tucson
State
AZ
Country
United States
Zip Code
85718
Taylor, Fiona; Higgins, Sophie; Carson, Robyn T et al. (2018) Development of a Symptom-Focused Patient-Reported Outcome Measure for Functional Dyspepsia: The Functional Dyspepsia Symptom Diary (FDSD). Am J Gastroenterol 113:39-48
Byrom, Bill; Watson, Chris; Doll, Helen et al. (2018) Selection of and Evidentiary Considerations for Wearable Devices and Their Measurements for Use in Regulatory Decision Making: Recommendations from the ePRO Consortium. Value Health 21:631-639
Arneri?, Stephen P; Kern, Volker D; Stephenson, Diane T (2018) Regulatory-accepted drug development tools are needed to accelerate innovative CNS disease treatments. Biochem Pharmacol 151:291-306
Safikhani, Shima; Gries, Katharine S; Trudeau, Jeremiah J et al. (2017) Response scale selection in adult pain measures: results from a literature review. J Patient Rep Outcomes 2:40
Hake, Ann M; Dacks, Penny A; Arneri?, Stephen P et al. (2017) Concise informed consent to increase data and biospecimen access may accelerate innovative Alzheimer's disease treatments. Alzheimers Dement (N Y) 3:536-541
Gries, Katharine; Berry, Pamela; Harrington, Magdalena et al. (2017) Literature review to assemble the evidence for response scales used in patient-reported outcome measures. J Patient Rep Outcomes 2:41
Neu, Scott C; Pa, Judy; Kukull, Walter et al. (2017) Apolipoprotein E Genotype and Sex Risk Factors for Alzheimer Disease: A Meta-analysis. JAMA Neurol 74:1178-1189
Eremenco, Sonya; Pease, Sheryl; Mann, Sarah et al. (2017) Patient-Reported Outcome (PRO) Consortium translation process: consensus development of updated best practices. J Patient Rep Outcomes 2:12
Naegeli, April N; Hanlon, Jennifer; Gries, Katharine S et al. (2017) Literature review to characterize the empirical basis for response scale selection in pediatric populations. J Patient Rep Outcomes 2:39
Gater, Adam; Nelsen, Linda; Fleming, Sarah et al. (2016) Assessing Asthma Symptoms in Adolescents and Adults: Qualitative Research Supporting Development of the Asthma Daily Symptom Diary. Value Health 19:440-50

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