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Dr. Terri Armstrong to lead efforts to improve the assessment of patient outcomes measures and their incorporation into clinical trials
Dr. Terri S. Armstrong, PhD, ANP-BC, FAANP, FAAN, has been named Senior Investigator, Patient Outcomes Program at the Neuro-Oncology Branch (NOB)* within the Center for Cancer Research (CCR) of the National Cancer Institute (NCI). According to the NCI, Dr. Armstrong’s work will focus primarily on improving the assessment of patient outcomes measures and their incorporation into clinical trials, including exploring the subtypes of brain tumors associated with significant symptoms and toxicity with the goal of developing interventions to improve patients’ lives.
The following is a statement from David F. Arons, Chief Executive Officer, National Brain Tumor Society:
“National Brain Tumor Society (NBTS) welcomes the addition of the new Senior Investigator, Patient Outcomes Program position at the NCI’s Neuro-Oncology Branch. This is a critical new role at the institute, and is tremendous news for brain tumor patients and the research community, alike.
Further, NBTS commends the leaders of the NIH, NCI, CCR, NINDS, and the selection committee for choosing Dr. Armstrong for the position in the Neuro-Oncology Branch, under the leadership of Dr. Mark Gilbert. Dr. Armstrong is an exceptional researcher, as well as clinical nurse, who has dedicated her career to improving the lives of brain tumor patients. Dr. Armstrong is widely-recognized for her expertise in field of applied neuro-oncology, particularly symptom reports, quality of life measures, patient reported outcomes, and clinical outcomes assessments, as well as her leadership efforts in incorporating these measures of symptom impact into brain tumor clinical trials.
Having had the privilege to collaborate with Dr. Armstrong through a number of NBTS initiatives**, I am delighted that she has been chosen to lead this crucial work at the federal government’s principal agency for cancer research. NBTS has the utmost confidence that Dr. Armstrong will fit perfectly into her new role and continue to help move the neuro-oncology field towards more patient-centric research and drug development.”
In the traditional oncology clinical trial process, most potential new medicines are evaluated to see if they can improve patient survival and extend life. Yet, while it remains the brain tumor field’s primary goal to develop life-extending and life-saving treatments, it is still nonetheless important to take into account patients’ symptoms, signs and functions during the drug development process. These measures provide important information on the impact of the tumor, and subsequent treatments, on patients and may help to fully understand the net impact of the disease and treatment. However, it wasn’t until recently that results have shown that it is feasible to include measurements of how a brain tumor patient feels and functions – known as “clinical outcome assessments”– in brain tumor clinical trials seeking drug approval.
Dr. Armstrong’s work played a major role in establishing this precedent, and though these measures are still not sufficiently included in registration trials, her new role at the NOB will continue to develop this discipline and further validate how trial sponsors can, and should, include patient outcome measures during drug development and evaluation.
“There is increasing recognition that clinical trials in the neuro-oncology setting that use only radiographic assessments or measures of overall or progression-free survival are inadequate for brain cancer patients. We know these patients not only want to live longer, but to live comfortably and function as well as they can, for as long as possible. Unfortunately, too often trials do not adequately include rigorous clinical outcome assessments. Yet, COAs are essential to understanding all of the potential patient benefits of a therapy under evaluation, including reducing symptoms, signs, and improving function.” – Dr. Terri S. Armstrong, November 2014
* The Neuro-Oncology Branch is a joint program of the CCR at the NCI and the National Institute of Neurological Disorders and Stroke (NINDS), all with the National Institutes of Health (NIH). Upon its establishment at the urging of brain tumor patient advocates in 2000 – with the legacy organizations of the National Brain Tumor Society at the forefront – the NOB became one of the first trans-institutional initiatives at the NIH. The NOB hosts both clinical and research functions, treating patients, as well as conducting and facilitating research to find better treatments for brain tumors. Thus the Branch plays an exceedingly important role as a treatment center option for patients, as well as the catalyst for brain tumor research.
**Dr. Armstrong serves as Vice Chair of the National Brain Tumor Society’s Clinical Trial Endpoints Steering Committee and is a member of NBTS’ Medical Advisory Board. She was critical to NBTS and our partners in the Jumpstarting Brain Tumor Drug Development Coalition’s efforts to convene leaders in the field in order to develop action plans to include measures of patient signs, symptoms, and function as part of the regular evaluation of therapy benefit