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Oncology NEWS International. Vol. 5 No. 7
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FDA Liaison Program Answers Patients' Questions About Trials

July 1, 1996

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

"Cancer survivorship has increased, and there are now approximately 10 million cancer survivors alive today in the United States," Ms. Delaney said. "This community of cancer survivors is not only growing, but more and more of them are actively involved in their treatment. This movement will continue to grow as more of the citizenry gains access to computerized information."

She explained that in 1992 about 20 cancer patient advocacy organizations met with the FDA and requested that they establish a permanent staff to deal with cancer patients, their families, survivorship groups, and cancer advocacy groups. The FDA responded with the Cancer Liaison Program within the Office of External Affairs.

Most callers to the program want information about cancer treatments currently being investigated, Ms. Delaney said. While the program is restricted by law from disclosing proprietary information about a drug under review, the staff may talk with patients about any treatment that appears in the PDQ database, which contains phase III trial information.

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

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

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

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