Does the TGN1412 trial disaster have lessons for clinical trials in India?
George
Thomas
T
Indian Journal of Medical Ethics, Mumbai, Maharashtra, India. george.s.thomas@gmail.com
Srinivasan
Sandhya
S
D000911:Antibodies, Monoclonal / Q000009:adverse effects* / Q000627:therapeutic use; D061067:Antibodies, Monoclonal, Humanized; D017321:Clinical Trials, Phase I as Topic / Q000009:adverse effects / Q000941:ethics*; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D015507:Drugs, Investigational; D006805:Human Experimentation / Q000941:ethics*; D006801:Humans; D007194:India; D038622:Internationality; D008297:Male; D009102:Multiple Organ Failure / Q000139:chemically induced; D009965:Orphan Drug Production; D011203:Poverty; D012449:Safety; D012945:Social Values; D006113:United Kingdom
D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D015507:Drugs, Investigational; C509303:TGN-1412