Princess Margaret Hospital

Straight Talk – Clinical Trials at University Health Network

We have identified a problem with data management and investigator oversight in a small number of breast cancer clinical trials.  We treat the conduct of clinical trials very seriously at UHN and I want to explain what we have found.

Our first duty is to the patients who agreed to participate in the trials as research subjects.  We have reviewed clinical records of all patients involved in the trials where data problems were identified.  The physicians responsible for the care of each patient have looked at the records of all patients entered on these studies.  I can say with confidence that no patient was harmed as a result of their participation in these trials as a research subject and that all patients received appropriate clinical care.   Some patients missed having some tests required by the research protocol of their trial and their physician has taken the necessary steps to ensure that these tests are completed.  Patients who missed tests which were required as part of the research protocol have already been contacted and most missing tests have been completed at this point in time.

We asked for external review of clinical trials in question after a sponsoring agency brought data management problems to our attention following a sponsor audit of specific trials.  The external review panel interviewed principal investigators, staff members involved in the clinical trial research and members of the senior staff of UHN.  In addition, the external panel had the audits of the clinical trials conducted by an external company at the request of UHN.  Dr. Chris Paige, our Vice President, Research organized the external audits and the external review processes in accordance with the guidelines governing investigation of problems in clinical trials.  The external review panel and external auditors have made it very clear that, while they found problems with the recording and tracking of research data and inadequate oversight on the part of the principal investigators and the organization, there was absolutely no evidence of data manipulation or falsification of data by the principal investigators responsible for the trials.

I also want to be clear that the inadequate paper work occurred in the tracking of the research studies which did not compromise the clinical record nor the clinical care that patients received.

Some of these trials were already closed and many of the identified problems have been remedied through actions that have been taken in the area and supported by the organization.  The investigators in the trials have taken the steps they are responsible for with the granting agencies, which includes voluntarily stopping some of the trials, notifying the agencies about the problems with the data, and taking the necessary remedial actions.  The investigators' integrity and care for their patients has been evident throughout.  In the short term we took the precautionary step of stopping accrual to several cancer trials so that we could review all processes and educate all research staff about this event and the actions necessary to meet the appropriate standard of trial conduct.  Some trials have since begun accruing again, which is appropriate.

It is our responsibility to take the learnings from this event and, working with investigators throughout the organization, ensure that we have the support, education, and training in place to support all clinical trials.  UHN is now in the process of conducting additional random internal audits across all three sites to ensure the organization is fulfilling its oversight responsibility and providing the support necessary to all clinical trials groups.  This internal audit process will be in addition to the audits conducted as a matter of routine by all sponsoring agencies.

We talk about our just culture and our desire to have errors reported so that we may learn, take action and move forward to establish an environment where it is difficult for errors to be made or repeated.  This is the approach we bring to the external review panel's recommendations.  Our response to this event is institution-wide and will involve everyone engaged in clinical trials research at UHN.  Drs. Chris Paige and Catherine Zahn are now co-chairing a Clinical Trials Oversight Committee which will report to UHN's Board of Trustees through the Quality of Care Committee.  In addition, we are in the process of hiring additional staff to support, train and educate all staff involved in clinical research at UHN.

Please visit www.uhn.ca/PMH/Whats_New.asp
for more information.

Bob

 

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