Princess Margaret Hospital

Breast Cancer Clinical Trials - Q & A

Q How did this problem come to the attention of UHN?
A   An external sponsor audit revealed some problems with some trials in our breast cancer program.  Further audits requested by UHN and an external review panel invited in to the organization by UHN provided more information about the difficulties with the trials.  Further internal audits will be done on a ‘spot audit’ basis throughout the organization with a view to ensuring the quality of clinical research throughout the organization.
Q Was anyone harmed as a result of the problems?
A No one was harmed.  The physicians responsible for the clinical care of the patients have reviewed the medical charts of all trial participants in the audited studies and are entirely comfortable in saying that no one was harmed.  The difficulties in these trials had everything to do with keeping trial data within the research record and nothing to do with the medical chart or the care provided.
Q Have patients been informed?
A Yes.  In some cases, patients were called so that arrangements could be made to conduct the tests necessary to comply with the research protocol.  In the event that it was determined that the research data might not be used, the patient was informed of that possibility and an apology was made because their support of a research initiative and a subsequent failure to be able to use the data represents a breach of the agreement between the subject and those conducting the trial. 
Q Why didn’t UHN find the problem first?
A  UHN has a number of research processes, supports and educational modules in place to train research staff.  In addition, we rely on external sponsor audits to ensure compliance with protocols.  We have excellent investigators who are accountable for the oversight of staff associated with trials, compliance with trial protocol and data quality.  Having had this experience, we believe that the organization needs an increased internal audit capacity, more training and certification for principal investigators and their research teams, and Board oversight for the quality of clinical research.  We have already taken steps to begin this process. 
Q Why didn’t you already have this in place?
A Most research organizations do not have a research oversight committee, nor do they have random internal audits.  We believe that the addition of these two processes will provide a benchmark for many others.  We already have standard operating procedures, education for research staff and the Research Ethics Board.  We also rely on the fact that investigators have a great deal of experience in conducting research.  Given what we have learned through this process, we will be strengthening our organizational oversight of clinical trials and having that oversight roll up through the Quality Committee of the Board of Trustees.
Q Is this isolated to one group or throughout the organization?
A We are aware of specific problems within the breast cancer program’s clinical trials.  We have initiated a wider random internal audit process so that we may properly answer that question.
What would you say to patients?
A   I would tell patients that the care that they received was appropriate and safe and that the errors were in the research documentation and process.  These errors mean that it is possible that some of the data collected on these trials may not be used, which is unfortunate.  I would apologize to the patients enrolled in these trials, as I believe that each patient who allowed themselves to be entered as a subject in a clinical trial did so with the intention of contributing to scientific knowledge.  For me, the possibility that we may not be able to use that data is a breach of trust with each patient who enrolled as a trial subject.  I would go on to say that we will learn from this experience and, as President & CEO of UHN, I will work with the team to ensure that our clinical research processes, education and support are improved and sufficient to meet our aspirations as a clinical research organization.
Q What’s the difference between the medical chart and the research documents?
A The medical chart for each patient documents every care activity received by the patient while receiving care in the hospital.  Some part of the chart is in paper form and a great deal of the chart is in electronic form.  The research documentation provides a record of the research process, including all study related visits and research activities outlined in the research study protocol (the documented research plan).  As the research study involves investigational treatments and requires tests to monitor safety and effect of the experimental treatment, it is important that anyone caring for the patient is informed.  So while research documentation is often within the medical chart, it describes the study-related activities.
Q You won’t name the trials.  Why not?
A  Patients who were study subjects in the trials and sponsoring agencies have been notified and are aware of what has happened.  Naming specific trials exposes individuals and this organization believes that the responsibility for these problems is a shared responsibility.  In addition, the organization is treating this as an issue for the entire enterprise of clinical research and the changes that are made will improve the support and oversight of all clinical trials at UHN. 
Q But, aren’t you then blaming everyone?
A  No.  We’re taking the appropriate actions to ensure that remedial action is taken for the immediate problems and taking an organizational view that we need to improve the oversight and processes for all of research at UHN.

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