Subscribe free at www.firstclinical.com © 2009 First Clinical Research and the Author(s) Is this a Seeding Trial?

Seeding trials are clinical studies primarily intended to promote use of the study drug by physicians and/or to convert physicians, especially opinion leaders — and study subjects — into advocates for the study drug. Seeding trials seed the market with product samples. The sponsor hopes that physicians and patients will continue using the drug after the trial. Seeding trials are unethical because they exploit study subjects for commercial purposes, create little or no medically useful knowledge, and deceive researchers, subjects and IRBs. In the interest of protecting human welfare, institutional review boards (IRBs) should not approve seeding trials. A seeding trial can occur only because the sponsor “does not disclose its true purpose to anyone who could say ‘no.’ ” 1 (p. 279) The question for the IRB thus becomes: Is the study under review a seeding trial? Inexperienced investigators and IRB members may not be familiar with the characteristics of seeding trials. Table 1 summarizes the six seeding trial criteria of Kessler, et al2 and six additional criteria of Sox and Rennie1. These researchers suggested that clinical trials sharing one or more of these flaws might be seeding trials, although some information may be difficult or impossible for the IRB to obtain. With the criteria in Table 1, IRBs can identif