Reed C R, Camargo C A
Department of Emergency Medicine, Massachusetts General Hospital, Boston 02114, USA.
Acad Emerg Med. 1999 Aug;6(8):833-9. doi: 10.1111/j.1553-2712.1999.tb01217.x.
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.
近年来，企业已成为生物医学研究资金的重要来源。企业赞助的临床试验尤其备受争议。鉴于近期的发展情况，作者重新评估了1995年急诊医学协会（SAEM）关于研究者参与企业赞助临床试验的指南。作者将企业资助的临床试验分为两类：研究者发起的和企业发起的，并讨论了它们之间的差异。他们审视了几个伦理辩论领域，包括主要研究者与企业赞助商之间的排他性合同、将患者招募到临床试验中的每位患者报销费用规模以及作者署名标准。最后，作者反对那种认为企业赞助的研究必然存在偏见的假设，并建议多层次审查将有助于发现偏见，无论其来源如何。一旦建立起对伦理准则和实践的相互尊重，就应鼓励急诊医学研究人员与企业之间的合作。
