Recent trends and controversies in industry-sponsored clinical trials.
In recent years, industry has become an important source of funding for biomedical research. Industry-sponsored clinical trials are a particular source of controversy. In light of recent developments, the authors reevaluate the 1995 SAEM guidelines for investigator involvement in industry-sponsored clinical trials. The authors divide industry-funded clinical trials into two categories: investigator-initiated and industry-initiated, and discuss the differences between them. They examine several areas of ethical debate, including exclusivity contracts between a principal investigator and a corporate sponsor, the size of per-patient reimbursements for recruiting patients into clinical trials, and authorship criteria. Finally, the authors oppose the assumption that industry-sponsored research is automatically biased, and suggest that multiple levels of review will help to uncover bias, whatever the source. Once mutual respect for ethical guidelines and practices are established, collaboration between emergency medicine researchers and industry should be encouraged.
Reed
C R
CR
Department of Emergency Medicine, Massachusetts General Hospital, Boston 02114, USA.
Camargo
C A
CA
D015982:Bias; D002986:Clinical Trials as Topic / Q000145:classification / Q000191:economics / Q000639:trends*; D004635:Emergency Medicine; D004992:Ethics, Medical; D005544:Forecasting; D017408:Guidelines as Topic; D006801:Humans; D007221:Industry; D017712:Peer Review, Research / Q000639:trends; D012107:Research Design; D012109:Research Support as Topic / Q000191:economics / Q000639:trends*; D014481:United States