Harriet S.MeyerMD, Contributing Editor, JAMADavid H.MorseMS, Journal Review EditorRobertHoganMD, adviser for new media
Copyright 2002 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.2002American Medical Association
by Margaret B. Liu and Kate Davis, 279 pp, paper, $69.95, ISBN 0-9712529-0-9, Durham, NC, Duke Clinical Research Institute, 2001.
This is an extremely readable, entertaining, and user-friendly manual of clinical trials prepared by two members of the Duke Clinical Research Institute, which is arguably the preeminent clinical research faculty in the country (no offense to my colleagues here at Harvard who may seize the title soon!). The authors state that they prepared this manual because there was no readily available resource to demystify the world of clinical research.
The title alludes to one of the many events that influenced the development of regulations affecting clinical research. In 1901 a horse named Jim was used to prepare an antitoxin for diphtheria. After the death of 13 children who received the antitoxin, authorities discovered that the horse had developed tetanus and therefore contaminated the antitoxin. As a result of this tragedy, Congress passed the Biologic Control Act of 1902, giving the government regulatory power over antitoxin and vaccine development.
Clinical TrialsLessons From a Horse Named Jim: A Clinical Trials Manual From the Duke Clinical Research Institute. JAMA. 2002;288(8):1017-1018. doi:10.1001/jama.288.8.1017-JBK0828-2-1