FDA Liaison Program Answers Patients' Questions About Trials

BETHESDA, Md--The volume of calls from cancer patients to theFDA's Cancer Liaison Program has increased steadily since theprogram was established at the end of 1993, Patty Delaney of theFDA said at a meeting of the Oncology Drugs Advisory Committee(ODAC)

"Cancer survivorship has increased, and there are now approximately10 million cancer survivors alive today in the United States,"Ms. Delaney said. "This community of cancer survivors isnot only growing, but more and more of them are actively involvedin their treatment. This movement will continue to grow as moreof the citizenry gains access to computerized information."

She explained that in 1992 about 20 cancer patient advocacy organizationsmet with the FDA and requested that they establish a permanentstaff to deal with cancer patients, their families, survivorshipgroups, and cancer advocacy groups. The FDA responded with theCancer Liaison Program within the Office of External Affairs.

Most callers to the program want information about cancer treatmentscurrently being investigated, Ms. Delaney said. While the programis restricted by law from disclosing proprietary information abouta drug under review, the staff may talk with patients about anytreatment that appears in the PDQ database, which contains phaseIII trial information.

Ms. Delaney and the Cancer Liaison Program staff inform patientsabout ongoing clinical trials, explain to patients and their familiesexactly what the words in a study mean, and most of all try toanswer their concerns with compassion and understanding.

Although many calls simply involve a search for information, thecalls can be more complex, such as an angry patient distraughtbecause the FDA has closed a clinical trial in which he was enrolled."We place a high premium on listening," she said. "Wetry never to argue with callers but rather to educate them aboutthe drug approval process. When that is not possible, we simplylisten."

The Cancer Liaison Program also serves as an access point forcancer patient advocacy organizations, works within the FDA tohelp patients become more involved with the drug approval process,and assists those FDA staff charged with the reviewing of cancerdrugs, devices, and biologics.

In late 1994, for example, the Center for Devices' Breast ImplantTask Force was working with the manufacturers of saline breastimplants who were having difficulty recruiting breast cancer patientsinto a study of the implants for use following mastectomy.

"The Cancer Liaison staff introduced the implant manufacturersto the breast cancer survivor organizations and provided technicalassistance on publicizing the existence of the study," Ms.Delaney said. "We also helped the manufacturers enter theirstudy into the PDQ database."

Ms. Delaney has first-hand knowledge of cancer and survivorshipissues. In 1987 she was diagnosed with stage IV Hodgkin's diseaseand enrolled in a National Cancer Institute clinical trial. Sheis now dedicated to "helping recently diagnosed cancer patientsmake complicated treatment decisions and informing them abouttheir option to choose a clinical trial."