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Study Closure Guidelines

Guidelines for Notifying Patients About Early Closure of Cancer Clinical Trials

Guidance for Better Care


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.


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.


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.


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.


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.


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: :

  • The reason for the trial closure; the expected health outcomes; any change in treatment plan
  • Treatment decision(s) that must be made
  • Follow-up required as a result of the new information


Participants will also receive a written copy of the information disclosed.


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.


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.


Notification of trial closure will be documented in the trial participant’s research record.