The HHS Inspector General's Office study of clinical trial recruitment practices will include a review of academic and industry clinical trial ads.

In addition to the ad reviews, the study, being run by the IG's Office of Evaluations and Inspections, will involve a survey of a random sample of institutional review boards (IRBs) and field visits to clinical trial sites to question investigators involved in recruiting. The office hopes to publish a draft report in late 1999.

The study follows a June 1998 IG draft report on IRBs. The 1998 study cautioned that advertising for clinical trials may lead to the misconception that a trial of an unapproved product is treatment rather than research.

The IG will evaluate guidelines that are in place and review existing literature on clinical trial recruitment. The study design is being finalized, and field work is expected to commence shortly.

One objective of the study will be to identify recruiting practices that appear questionable and make recommendations for deterring such practices. The study will evaluate the effectiveness of HHS oversight of sponsor and investigator efforts to achieve timely recruitment of human subjects for clinical trials, particularly in the context of a demand for shorter trials and greater enrollment of subpopulations, such as women and children.

The IG also will examine the difficulties investigators face in recruiting subjects for clinical trials, look at the range of recruitment strategies being used and review federal and nonfederal recruitment guidelines.

Matching interested patients with recruiting trials may become easier with the development of a clinical trial database by the National Institutes of Health and FDA, as mandated by the FDA Modernization Act.

The database eventually will include all federally and privately funded clinical trials of serious and life-threatening diseases, and will begin prototype testing within NIH during the summer and early fall.

The first public version of the database, which will include all NIH-sponsored trials, will be available by year-end. Industry trials and those sponsored by other government agencies will be added beginning in January.

Clinical Trial Recruitment Ad Review To Be Included In IG Study

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