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Patient Advocacy Resources
Guidelines for Notifying Patients About Early Closure of Cancer Clinical
Trials
Respect for the research participant is a
fundamental moral requirement of human subjects research. Disclosure of
information regarding the results of cancer clinical trials in which participants are
enrolled is essential to the informed consent process and to respect for
participants. It is an ethical obligation of researchers.
On this basis, the Patient Advisory Board of the
Coalition of Cancer Cooperative Groups offers the following guidelines for all
Phase III clinical trials that are closed prematurely by a Data Monitoring
Committee (DMC), Data Safety Monitoring Board (DSMB), or other Committee with
these responsibilities.
1.
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Disclosure to individual participants of the results of cancer clinical
trials, including early disclosure, will be the ethical norm. However,
disclosure must not violate any state or federal laws regarding breaking the
code on anonymized data.
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2.
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The individual who provided the original consent to participate in the research
will be informed of the results of the cancer clinical trial by their treating
physician, or absent the treating physician, by the institutional principal
investigator (PI) or his/her designee. If the participant was a child at the
time of trial treatment but has reached the age of maturity at the time of
trial closure, the participant should be notified of the closure directly by
their treating physician, or when necessary by the institutional PI or his/her
designee. Participants will be informed in a manner that will ensure that they
receive the results with a minimum of disruption to the patient-physician
relationship.
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3.
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The treating physician will be notified of trial closure within 30 days of the
PI's/Cooperative Group's receipt of the DMC/DSMB decision to close that trial.
Each participant will also be notified in a timely manner of early closure of
the cancer clinical trial by the treating physician, or when necessary by the institutional PI
or his/her designee. It is reasonable to expect that such notification will
occur within 60 days of the receipt of notification of the DMC/DSMB decision by
the treating physician.
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4.
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Any research participant or family member who is approached with the intent of
sharing research results shall have the right to decline to receive any or all
of the results of the cancer clinical trial.
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5.
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The results of research will be shared either verbally or in person with the
participant or his/her chosen designee by the treating physician, or when
necessary the institutional PI or his/her designee. This conversation should
not be held over the phone unless absolutely necessary.
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6.
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The treating physician or, when necessary, the institutional PI or his/her
designee should include the following information during his/her discussion
with the trial participant: :
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The reason for the trial closure; the expected health
outcomes; any change in treatment plan
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Treatment decision(s) that must be made
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Follow-up required as a result of the new information
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7.
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Participants will also receive a written copy of the information disclosed.
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8.
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The information will be provided in lay terminology that is clear and
understandable to the participant, with reference to any existing medical
literature, and in sufficient detail to answer the participant’s questions.
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9.
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If the cancer clinical trial is a Cooperative Group trial, the Cooperative Group office
will provide a sample letter for the treating physician or institutional PI. It
is the responsibility of the investigator to secure appropriate institutional
review board approval.
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10.
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Notification of trial closure will be documented in the trial participant’s
research record.
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