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FDA Liaison Program Answers Patients' Questions About Trials

FDA Liaison Program Answers Patients' Questions About Trials

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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