Clinical Trial Recruitment Ad Review To Be Included In IG Study

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 IRBs and field visits to clinical trial sites to question investigators and others involved in recruiting. The office hopes to publish a draft report in late 1999.

The study follows a June 1998 IG draft report on institutional review boards. 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 Pink Sheet" June 8, 1998, p. 29).

Merck recently ran TV ads to boost recruitment for a rheumatoid arthritis trial of its COX-2 inhibitor Vioxx (rofecoxib) ("The Pink Sheet" April 12, p. 9).

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

One objective of the study will be to identify recruiting practices that appear questionable and find recommendations for deterring such practices.

The IG 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.

IG will also examine the difficulties that investigators face in recruiting human 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 summer and early fall 1999.

The first public version of the database, which will include all NIH-sponsored trials, will be available by the end of 1999. Industry trials and those sponsored by other government agencies will be added beginning in January 2000 ("The Pink Sheet" Sept. 21, 1998, p. 14).

FDAMA clinical trial database provisions require four pieces of information to be included for each trial: the study's purpose, eligibility criteria, study locations and a point of contact. Although this information represents the minimum requirement, additional data will be included for NIH trials, and submission of additional information on industry studies will be encouraged.

What exactly should be submitted for each trial is still being determined. Although drug name is not required under FDAMA, FDA is considering making it a field of information in the database. Patients may be able to search a variety of fields, including study sponsor, drug name and trial status.

When NIH started posting clinical trials on its AIDS Clinical Trial Information Services site, companies were reluctant to provide information beyond that which was required. However, over time sponsors felt more comfortable adding more information, NIH said.

The Pharmaceutical Research & Manufacturers of America emphasized the required clinical information under FDAMA at a November 1998 meeting with NIH/FDA database project staff.

PhRMA's "bottom line message...was a reminder about the fact that there are four datapoints required in the legislation," NIH Office of Science Policy and Planning Director Robin Kawazoe said at an NIH Director's Council of Public Representatives meeting in April.

PhRMA, however, also expressed "an openness to consider voluntary submission of some additional information about trials," she added.

An FDA working group of approximately 8-10 members, headed by Associate Commissioner for Special Health Issues Theresa Toigo, is currently working on a definition of "efficacy trials" for the purpose of defining what trials will be included in the database.