Minimising risk in first-in-man trials

Lancet

Volumn 369, Issue 9572, 2007, Pages 1496-1497

  Hemelaar, Joris ^a  

^a MAGDALEN COLLEGE   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

CYTOKINE; MONOCLONAL ANTIBODY CD28; PLACEBO; TGN 1412; UNCLASSIFIED DRUG;

ARTICLE; AUTOIMMUNE DISEASE; AUTOIMMUNITY; BLOOD SAMPLING; CLINICAL RESEARCH; CLINICAL TRIAL; CYTOKINE RELEASE; DRUG CLASSIFICATION; DRUG SAFETY; DRUG SPECIFICITY; DRUG TOLERABILITY; HEADACHE; HOSPITAL ADMISSION; HUMAN; IMMUNE DEFICIENCY; INFORMED CONSENT; LEUKEMIA; LOW BACK PAIN; LOW DRUG DOSE; MULTIPLE ORGAN FAILURE; MYALGIA; NONHUMAN; PRACTICE GUIDELINE; PRIORITY JOURNAL; RIGOR; RISK ASSESSMENT; SIDE EFFECT; UNITED KINGDOM; UNSPECIFIED SIDE EFFECT;

EID: 34247874576     PISSN: 01406736     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0140-6736(07)60686-2     Document Type: Note

References (7)

1. Suntharalingam G., Perry M., Ward S., et al. Cytokine storm in a phase 1 trial of the anti-CD28 monoclonal antibody TGN1412. N Engl J Med 355 (2006) 1018-1028
2. Beyersdorf N., Hanke T., Kerkau T., and Hunig T. CD28 superagonists put a break on autoimmunity by preferentially activating CD4+CD25+ regulatory T cells. Autoimmun Rev 5 (2006) 40-45
3. Medicines and Healthcare products Regulatory Agency. Investigations into adverse incidents during clinical trials of TGN1412 (May 25, 2006). http://www.mhra.gov.uk/home/idcplg?IdcService=GET_FILE&dDocName=CON2 023821&RevisionSelectionMethod=LatestReleased (accessed April 24, 2007)
4. Department of Health. Expert scientific group on phase one clinical trials: final report (Dec 7, 2006). http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/Publicati onsPolicyAndGuidance/DH_063117 (accessed April 24, 2007)
5. Royal Statistical Society. Report of the working party on statistical issues in first-in-man studies (March, 2007). http://www.rss.org.uk/pdf/Royal%20Statistical%20Society%20Working%20Part y%20on%20First%20in%20Man%20Studies%20-%20online%20version.pdf (accessed April 25, 2007)
6. Kenter M., and Cohen A. Establishing risk of human experimentation with drugs: lessons from TGN1412. Lancet 368 (2006) 1387-1391
7. European Medicines Agency. Guideline on requirements for first-in-man clinical trials for potential high-risk medicinal products (March 27, 2007). http://www.emea.europa.eu/pdfs/human/swp/2836707en.pdf (accessed on April 24, 2007)