Publication of pivotal efficacy trials for novel therapeutic agents approved between 2005 and 2011: A cross-sectional study

JAMA Internal Medicine

Volumn 174, Issue 9, 2014, Pages 1518-1520

  Smithy, James W ^a   Downing, Nicholas S ^a   Ross, Joseph S ^a  

^a YALE UNIVERSITY SCHOOL OF MEDICINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

NEW DRUG;

CLINICAL TRIAL (TOPIC); DRUG APPROVAL; DRUG EFFICACY; DRUG INDICATION; FOOD AND DRUG ADMINISTRATION; LETTER; MEDICAL LITERATURE; PEER REVIEW; PIVOTAL EFFICACY TRIAL; PUBLISHING; CROSS-SECTIONAL STUDY; HUMAN; STATISTICS AND NUMERICAL DATA; UNITED STATES;

CLINICAL TRIALS AS TOPIC; CROSS-SECTIONAL STUDIES; DRUG APPROVAL; HUMANS; PUBLISHING; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84907013106     PISSN: 21686106     EISSN: 21686114     Source Type: Journal    
DOI: 10.1001/jamainternmed.2014.3438     Document Type: Letter

References (5)

1. Downing NS, Aminawung JA, Shah ND, Krumholz HM, Ross JS. Clinical trial evidence supporting FDA approval of novel therapeutic agents, 2005-2012. JAMA. 2014;311(4):368-377.
2. Lee K, Bacchetti P, Sim I. Publication of clinical trials supporting successful new drug applications: a literature analysis. PLoS Med. 2008;5(9):e191.
3. Turner EH, Matthews AM, Linardatos E, Tell RA, Rosenthal R. Selective publication of antidepressant trials and its influence on apparent efficacy. N Engl J Med. 2008;358(3):252-260.
4. Ross JS, Gross CP, Krumholz HM. Promoting transparency in pharmaceutical industry-sponsored research. Am J Public Health. 2012;102(1): 72-80.
5. US National Library of Medicine; US National Institutes of Health; US Department of Health and Human Services. ClinicalTrials.gov: Advanced Search. http://clinicaltrials.gov/ct2/search/advanced. Accessed October 30, 2013.