Seeding Trial - in Medicine

In Medicine

Seeding trials to promote a medical intervention were described as "trials of approved drugs appear to serve little or no scientific purpose" and "thinly veiled attempts to entice doctors to prescribe a new drug being marketed by the company" in a special article in the New England Journal of Medicine. The article, whose authors included U.S. Food and Drug Administration commissioner David Aaron Kessler, also described a number of characteristics common to seeding trials:

• The trial is of an intervention with many competitors
• Use of a trial design unlikely to achieve its stated scientific aims (e.g., un-blinded, no control group, no placebo)
• Recruitment of physicians as trial investigators because they commonly prescribe similar medical interventions rather than for their scientific merit
• Disproportionately high payments to trial investigators for relatively little work
• Sponsorship is from a company's sales or marketing budget rather than from research and development
• Little requirement for valid data collection

In a seeding trial, doctors and their patients are given free access to a drug and exclusive information and services to use the drug effectively. Additionally, participating physicians are often given financial remuneration and a chance to be a co-author on a resulting scientific publication. By triggering the Hawthorne effect, physicians become "opinion-leading word-of-mouth advocates". This practice has been shown to be effective.

Seeding trials are not illegal, but such practices are considered unethical. The obfuscation of true trial objectives (primarily marketing) prevents the proper establishment of informed consent for patient decisions. Additionally, trial physicians are not informed of the hidden trial objectives, which may include the physicians themselves being intended study subjects (such as in undisclosed evaluations of prescription practices). Seeding trials may also utilize inappropriate promotional rewards, which may exert undue influence or coerce desirable outcomes.