OIG Says Clinical Trial Web Sites Need Improvement
The OIG report (PDF) examined 110 clinical trial listings at 22 Web sites sponsored by a variety of organizations, including the federal government, commercial organizations, and academic institutions.
A survey released in May by CenterWatch Inc., a Boston-based clinical trials listing service, found that 30 percent of those who volunteer for a clinical trial do not understand that the therapy may pose risks to participants.
The CenterWatch survey also found that 70 percent of clinical trial participants did not know the types of questions to ask during the informed-consent process. Eighteen percent said they had given informed consent without first consulting their physician or speaking to a nurse, a family member, or a "trusted advocate."
Information for the online survey was obtained in January and February 2002 from some 1,600 people who had completed a clinical trial within the past six months.
According to the report, which was released in May, all but one Web site provided useful, general information explaining the importance of informed consent. Sixteen of the 22 sites discussed the overall purpose of clinical trials. Twelve described the role of clinical trials in evaluating a drug's safety and efficacy and determining whether the product will receive marketing approval from the Food and Drug Administration.
Of the 110 individual listings at the 22 Web sites, 91 described the trial's eligibility requirements and 80 clearly stated the purpose of the study. Although 29 of the listings touted the benefits of participating in the study, none provided specific information about the potential risks.
Also troubling to OIG was the finding that 77 of the online listings did not disclose the trial's sponsor, 69 failed to state the phase of the clinical trial, and 56 did not contain a general description of the trial's protocol.
OIG described as misleading the Web sites that claimed participants in clinical trials benefit from gaining access to medicines not yet on the market. Such statements, OIG said, overlook the fact that the product under investigation may not be safe and effective for the treatment of the patient's illness.
Thirteen of the 22 Web sites collected personal information from potential study participants, a practice that OIG called reasonable. But the report noted that nine of the Web sites did not have security measures to protect personal information. Seven of the Web sites did not disclose whether personal information collected online would be shared with the staff running the study.
Despite the shortcomings of some of the online listings of clinical trials, OIG concluded that the Web sites can be useful tools for patient education and recruitment. OIG suggested that standards be developed to guide the content of clinical trial Web sites. The report also suggested that Web sites submit to an institutional review board all of the material on a study's risks and benefits before publishing the information on the Web.