title: TGN1412: time to change the paradigm for the testing of new pharmaceuticals.
abstract: Clinical studies in human volunteers are an essential part of drug development. These studies are designed to account for possible differences between the effects of pharmaceutical products in preclinical studies and in humans. However, the tragic outcome of the recent Phase 1 clinical trial on TGN1412 casts considerable doubt over the relevance of this traditional drug development paradigm to the testing of therapeutic agents for human use. The role of alternatives to animal testing is considered, and a series of recommendations are made, which could ensure that clinical trials are well informed and based on the most relevant scientific information.
authors.affiliation: FRAME, 96-98 North Sherwood Street, Nottingham, NG1 4EE, UK. Nirmala@frame.org.uk
authors.forename: Nirmala
authors.initials: N
authors.lastname: Bhogal
authors.forename: Robert
authors.initials: R
authors.lastname: Combes
mesh_terms: D000595:Amino Acid Sequence; D000826:Animal Testing Alternatives; D000818:Animals; D000911:Antibodies, Monoclonal / Q000009:adverse effects*; D061067:Antibodies, Monoclonal, Humanized; D017321:Clinical Trials, Phase I as Topic; D004353:Drug Evaluation, Preclinical / Q000379:methods*; D015507:Drugs, Investigational; D006287:Health Planning Guidelines; D006801:Humans; D008297:Male; D008969:Molecular Sequence Data; D009102:Multiple Organ Failure / Q000209:etiology; D033281:Nontherapeutic Human Experimentation; D016415:Sequence Alignment
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D015507:Drugs, Investigational; C509303:TGN-1412