Seeding trials ^(3,4)

Seeding trials are studies that camouflage as scientific research, but actually designed for marketing purposes. They are usually associated with pharmaceutical companies that use them to introduce new drugs to physician-researchers.

There is no clear proof that seeding trials exist, since their marketing objectives are often purposefully hidden. However, some of their characteristics have been described:

• Testing of a drug in the last stages of its development (when it is about to be marketed), e.g. late phase 3 or phase 4 trials.
• Heavy involvement of the marketing department in trial design, conduct and data analysis.
• Involvement of many centres and physicians, but each centre and physician recruiting only a few subjects.
• Questionable scientific value, for example, short follow-up period, lack of comparison group.
• Collection of data that does not seem to justify the research question, for example, physicians’ prescription rates of a trial drug.

Hill et al presented a known seeding trial in their paper ‘The ADVANTAGE Seeding Trial: A Review of Internal Documents’ (2008).

Why are seeding trials unethical?