How can institutional review boards best interpret preclinical data?

PLoS Medicine

Volumn 8, Issue 3, 2011, Pages

  Lavery, James V ^a,b  

^a ST MICHAEL'S HOSPITAL   (Canada)

^b UNIVERSITY OF TORONTO   (Canada)

Author keywords

[No Author keywords available]

Indexed keywords

TGN 1412;

ARTICLE; B LYMPHOCYTE; CLINICAL PROTOCOL; CLINICAL RESEARCH; CLINICAL TRIAL (TOPIC); CYTOKINE STORM; DECISION MAKING; EXPERIMENTAL ANIMAL; HUMAN; MACACA; MULTIPLE ORGAN FAILURE; NONHUMAN; RISK BENEFIT ANALYSIS; SAFETY; TREATMENT OUTCOME; UNITED KINGDOM; DRUG SCREENING; ETHICS; NOTE; PROFESSIONAL STANDARD; REPRODUCIBILITY; RESEARCH ETHICS; RISK ASSESSMENT; UNCERTAINTY;

CLINICAL TRIALS AS TOPIC; DRUG EVALUATION, PRECLINICAL; ETHICS COMMITTEES, RESEARCH; ETHICS, RESEARCH; HUMANS; REPRODUCIBILITY OF RESULTS; RISK ASSESSMENT; UNCERTAINTY;

EID: 79953691137     PISSN: 15491277     EISSN: 15491676     Source Type: Journal    
DOI: 10.1371/journal.pmed.1001011     Document Type: Article

References (3)

1. Kimmelman J, London AJ, (2011) Predicting harms and benefits in translational trials: Ethics, evidence, and uncertainty. PLoS Med 8 (3): e1001011 doi:10.1371/journal.pmed.1001011.
2. Suntharalingam G, Perry MR, Ward S, Castello-Cortes A, et al. Brett Sj (2006) Cytokine storm in a phase 1 trial of the anti-CD28 monoclonal antibody TGN1412. N Engl J Med 355: 1018-1028.
3. Fleming N, (2008) Study claims to solve drug trial mystery. The Telegraph (London) Available: http://www.telegraph.co.uk/news/uknews/1540591/Study-claims-to-solve-drug-trial-mystery.html. Accessed 31 January 2011.