The clinical trials transformation initiative: Innovation through collaboration

Nature Reviews Drug Discovery

Volumn 13, Issue 11, 2014, Pages 797-798

  Tenaerts, Pamela ^a   Madre, Leanne ^a   Archdeacon, Patrick ^b   Califf, Robert M ^a  

^a DUKE UNIVERSITY SCHOOL OF MEDICINE   (United States)

^b CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CLINICAL EFFECTIVENESS; CLINICAL STUDY; CLINICAL TRIAL (TOPIC); CLINICAL TRIALS TRANSFORMATION INITIATIVE; FOLLOW UP; FOOD AND DRUG ADMINISTRATION; GOVERNMENT; INFORMED CONSENT; MEDICAL PRACTICE; MONITORING; NOTE; RANDOMIZED CONTROLLED TRIAL (TOPIC); SAFETY; WORKSHOP; COOPERATION; HUMAN; UNITED STATES;

CLINICAL TRIALS AS TOPIC; COOPERATIVE BEHAVIOR; HUMANS; RANDOMIZED CONTROLLED TRIALS AS TOPIC; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84908478458     PISSN: 14741776     EISSN: 14741784     Source Type: Journal    
DOI: 10.1038/nrd4442     Document Type: Note

References (5)

1. Landray, M. J. et al. Clinical trials: rethinking how we ensure quality. Drug Inf. J. 46, 657-660 (2012).
2. Archdeacon, P. et al. Optimizing expedited safety reporting for drugs and biologics subject to an investigational new drug application. Ther. Innov. Regul. Sci. 48, 200-207 (2013).
3. US FDA. Investigational new drug safety reporting requirements for human drug and biological products and safety reporting requirements for bioavailability and bioequivalence studies in humans. Fed. Regist. 75, 59935-59963 (2010).
4. Menikoff, J. The paradoxical problem with multiple-IRB review. N. Engl. J. Med. 363, 1591-1593 (2010).
5. Flynn, K. E. et al. Using central IRBs for multicenter clinical trials in the United States. PLoS ONE 8, e54999 (2013).