Supposedly well-conducted drug trials are critical for pharmaceutical companies to obtain FDA approval for new products. However, this government investigation found that, the techniques and methods used to recruit patients for these trials are often unethical and "disturbing".

Some examples of problems cited in the report:

• Drug companies try to boost enrollment by offering financial incentives to doctors and by advertising their studies
• Researchers may enroll patients who should not be eligible in order to meet quotas and satisfy sponsors
• Doctors sometimes ask their own patients to be potential subjects
• A nursing home patient allegedly was forced to either participate in a clinical trial or leave the home.
• Some patients were contacted repeatedly in order to try and persuade them to enroll in trials.

There are concerns that such recruiting practices might interfere with patients' ability to give "informed consent" to participate by weighing a treatment's possible benefits and risks.

According to the report, industry-funded trials may be engaging in this type of activity because "in recent years the clinical research environment has become more commercialized and competitive."

Although federal agencies have begun to take steps to make sure clinical investigators follow rules designed to protect patients enrolled in trials, investigators recommended that health officials take additional steps, including working with industry and researchers to devise guidelines on proper recruitment policies.

Report From Inspector General for the Department of Health and Human Services, June 2000