Agency
National Institute of Health (NIH)
Institute
Food and Drug Administration (FDA)
Type
Research Program--Cooperative Agreements (U19)
Project #
1U19FD003800-01
Application #
7906404
Study Section
Special Emphasis Panel (ZFD1-SRC (99))
Program Officer
Needleman, Katherine
Project Start
2009-09-20
Project End
2014-08-31
Budget Start
2009-09-20
Budget End
2010-08-31
Support Year
1
Fiscal Year
2009
Total Cost
Indirect Cost
Name
Duke University
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
044387793
City
Durham
State
NC
Country
United States
Zip Code
27705
Herrington, William G; Goldsack, Jennifer C; Landray, Martin J (2018) Increasing the use of mobile technology-derived endpoints in clinical trials. Clin Trials 15:313-315
Corneli, Amy; Wheeler, Chris; Bradley, John et al. (2018) Facilitators and barriers to the successful implementation of pediatric antibacterial drug trials: Findings from CTTI's survey of investigators. Contemp Clin Trials Commun 9:115-120
Calis, Karim A; Archdeacon, Patrick; Bain, Raymond et al. (2017) Recommendations for data monitoring committees from the Clinical Trials Transformation Initiative. Clin Trials 14:342-348
Arango, Jaime; Chuck, Tina; Ellenberg, Susan S et al. (2016) Good Clinical Practice Training: Identifying Key Elements and Strategies for Increasing Training Efficiency. Ther Innov Regul Sci 50:480-486
Holland, Thomas L; Mikita, Stephen; Bloom, Diane et al. (2016) Patient and physician attitudes regarding risk and benefit in streamlined development programmes for antibacterial drugs: a qualitative analysis. BMJ Open 6:e013561
Meeker-O'Connell, Ann; Glessner, Coleen; Behm, Mark et al. (2016) Enhancing clinical evidence by proactively building quality into clinical trials. Clin Trials 13:439-44
Lewis, Roger J; Calis, Karim A; DeMets, David L (2016) Enhancing the Scientific Integrity and Safety of Clinical Trials: Recommendations for Data Monitoring Committees. JAMA 316:2359-2360
Hallinan, Zachary P; Forrest, Annemarie; Uhlenbrauck, Gina et al. (2016) Barriers to Change in the Informed Consent Process: A Systematic Literature Review. IRB 38:1-10
Lentz, Jennifer; Kennett, Michele; Perlmutter, Jane et al. (2016) Paving the way to a more effective informed consent process: Recommendations from the Clinical Trials Transformation Initiative. Contemp Clin Trials 49:65-9
Madre, Leanne; Tenaerts, Pamela (2016) How Public-Private Collaborations Are Driving Solutions to the Antibacterial Drug Development Crisis. Clin Infect Dis 63 Suppl 2:S25-6

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