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Guidelines Developed for Management of Phase I Trial Waiting Lists

Guidelines Developed for Management of Phase I Trial Waiting Lists

SAN DIEGO--To relieve the anxiety and frustration cancer patients
may feel when being put on a waiting list for enrollment into a phase I trial,
clinical trials managers at Vanderbilt have developed wait list guidelines
driven by compassion and ethics, said Cindy Foss, BBA, program coordinator, and
Teresa Knoop, RN, MSN, AOCN, cancer information nurse specialist and director
of the Cancer Information Program (CIP), Vanderbilt-Ingram Cancer Center,

Ms. Foss and Ms. Knoop addressed this philosophy and the program born out of
it at the 26th Annual Conference of the Oncology Nursing Society (ONS abstract

The Vanderbilt-Ingram Cancer Center opened a dedicated phase I clinical
trials office in 1998. "We wanted a fair and reasonable way for patients
to have access to those slots," Ms. Knoop said. "Phase I trials are
especially limited because, as safety studies, they move slowly. There can be
fewer slots available because no other trials are going on in that area or
because the drug company imposes restrictions."

The Cancer Center receives patient referrals from physicians at their
institution and from the neighboring communities. Waiting lists are a
necessity, and placement on the list is based on the date the referral is
received. "We do it that way to avoid favoritism or judgments," Ms.
Foss said. "It’s the only fair way to go about it."

Ms. Foss and Ms. Knoop developed additional strategies to create a fair and
compassionate waiting list process. These include a centralized system for both
internal and external referrals, standardized forms, and procedures for keeping
patients, families, and physicians fully informed.

Generally, a physician will contact the CIP about clinical trial
availability. CIP will confirm receipt of the inquiry and request a completed
referral form for review. CIP then provides the physician with information
about trial availability and the time frame, at which point the patient is
placed on the wait list and given CIP as a contact for any questions or

As part of the program, CIP also inserted a platform of ethical behavior
that addresses the issues of autonomy, beneficence, compassion, and justice.


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