September 26, 2016
Improper trial/study design
Researchers may select certain patients who are more likely to lead to a satisfactory result, by setting strict inclusion and exclusion criteria that are not aligned with the wider community or the patient constituency for which the product is intended. The danger of improper design in randomised controlled trials and other studies, is that the medical knowledge generated does not reflect the people who are using a particular product, so they may be getting suboptimal treatment.
Seeding trials are clinical trials designed by pharmaceutical companies to appear as if they answer a scientific question but primarily fulfilling marketing objectives, encouraging the use and unapproved use of their products. In particular, seeding trials allow the supplier to put its product in the hands of practising doctors. The existence of such studies has long been suspected, but published information about them has been limited. The failure to disclose the true objectives of the trial to patients, investigators, or institutional review board members is not in the best interests of patients or the medical profession, and is an abuse of the entrusted power pharmaceutical companies have to research and produce needed medicines.