Clinical Trial Information On The Internet

From Orphan Disease Update 2002, Volume XX, Edition 3

The U.S. Department of Commerce says that 35 percent of Internet users look for heath information every month on the World Wide Web. About 40 percent are women, and 30 percent are men; 42.7 percent of users over the age of 55 search for health information online. More high-income people use the Internet for health information than low-income people.

In May 2002, the Inspector General of the Department of Health & Human Services (HHS) issued a new report, "Clinical Trial Web Sites: A Promising Tool to Foster Informed Consent." The Inspector General noted that there are many clinical trial web sites that are aimed at recruiting people to participate in medical research. Some of them have grown rapidly, such as the government run "CancerNet" (from the National Cancer Institute), which leaped from 500,000 visitors per week in 2000 to an average of 700,000 visitors per week in 2001. A privately operated site, CenterWatch, increased from 38,000 visitors per week in 1997 to 334,000 per week in 2000. This illustrates the growing public interest in biomedical research.

Pharmaceutical companies sometimes have difficulty recruiting volunteers for clinical trials, and web sites give them access to a large number of people at a relatively low cost for recruitment. However, the Inspector General found that most of the web sites excluded important information that people should have before they decide whether to participate. For example, while many sites reported the potential benefits of an experimental treatment, none reported the potential risks. Obviously, information on these web sites should be balanced and truthful so potential volunteers can have realistic expectations.

The HHS study found that 77 of 110 clinical trial listings on the web sites did not identify the sponsor of the experiment. Potential volunteers should know whether the trial is sponsored by the government (e.g. the National Institute of Health, etc.) or a private corporation. Sixty-nine of the experiments did not indicate whether it was an early phase trial (e.g. Phase I is the first phase of human experimentation, when hardly anything is known about the drug, while in Phase III trials there may be substantial knowledge of safety but not of effectiveness). Additionally, fifty-six of the listings did not adequately describe the protocol so potential volunteers could not determine how long they were expected to participate, the kinds of tests that were required, and whether the clinical site would be convenient.

Some of the web sites provided misleading information, according to the report. One site inaccurately said that a Phase I trial had a substantial chance of treatment "success", and another site said that clinical trials provide access to new treatments, when in fact experimental drugs are not "treatments." In fact, most experimental drugs fail to pass muster because they are found to be either unsafe or ineffective. A drug is no longer "experimental" only after is is proven to be safe and effective.

Many of the web sites did not disclose how they will use the personal information that they collect from people, and many did not disclose information about their financial relationships with sponsors of the studies. Some sites may be paid for each volunteer who is recruited through the web site, and that could possibly bias the way information is presented to the public. Others may be given a flat fee so they will not directly benefit from the number of people who volunteer.

The Inspector General recommends that Institutional Review Boards (IRBs), which have responsibility for protecting human subjects in research, should have oversight of advertisements aimed at recruiting patients for clinical trials. IRBs should ensure that clinical trial web sites adhere to federal regulations, especially in regard to privacy and confidentiality of personal medical information that people voluntarily provide to the web site administrators. However, privately run clinical trials that do not receive federal funds do not have to comply with the same federal human protection rules if federal funds are not involved.

The report also recommends that clinical trial web sites should adopt voluntary standards to which all will adhere, if they don’t want the government to step in. Such standards should include periodic mandatory review by an independent body to ensure that the information on each web site is balanced, not misleading or coercive, and that confidentiality of personal medical information is properly protected.

Since web site recruitment of research volunteers is a new phenomenon, there are no current universal standards, and Institutional Review Boards have been unsure of the scope of their responsibility in monitoring these sites. It is hoped this HHS report may spur development of a code of standards that all clinical trial web sites adopt.