NRG Currents - May 2024 eNewsletter

May 2024

www.nrgoncology.org

Welcome to the NRG Oncology eNewsletter

If you have a suggestion or would like to submit content to our Communications team, please email communications@nrgoncology.org

Brain Cancer Awareness Month

NRG Oncology is currently enrolling patients on several brain cancer studies in our portfolio. Search for active studies on the NRG Oncology website protocol table.

NRG New Protocols Under Development & Study News

Summary of Research Results for NRG Oncology Study Participants

NRG Oncology is pleased to announce the start of our new initiative to provide patient-friendly summaries of recently published results of NRG Oncology studies. The first two study results summaries to be released and published on the group’s website are for NCORP studies NRG-CC001, A Randomized, Phase III Trial of Memantine and Whole-Brain Radiotherapy With or Without Hippocampal Avoidance in Patients With Brain Metastases, and NRG-CC004, Phase II Double Blind Dose Finding Trial of Bupropion Versus Placebo for Sexual Desire in Women With Breast or Gynecologic Cancer. These are now available on the NRG Oncology patient study webpages (https://www.nrgoncology.org/CC001 and https://www.nrgoncology.org/CC004).

New Protocols Under Development

NRG Oncology has issued a chart of new protocols under development. These protocols will include the study’s disease site, title, Principal Investigator, and any comments pertaining to the study’s anticipated activation.

The updated listing as of April 30, 2024 can be found here.

Leveraging Veteran Data for the Benefit of Veteran Cancer Patients

Written by Vlad C. Sandulache MD PhD and Maria Kelly MD

National Veterans Research Week (May 13-17) highlights advances in clinical care for our nation’s Veterans across the breadth of disease entities brought about through a continuous bench to bedside approach. This year’s theme is “Building Community Through Research” and will focus on celebrating the accomplishments of researchers and clinicians in bringing state of the art treatments and cures to Veteran patients.

Three years into its newly re-organized form, the NRG Oncology Veterans Affairs and Military Treatment Facilities Subcommittee continues to bring together researchers and clinicians from across the large Veterans Health Administration and Department of Defense communities in order to make state of the art clinical trials available to Veterans with cancer.

Protocol Support Committee (PSC) Column

Guidance on the Re-consenting Process

Written by Minh N. Tran, BSN, OCN, CCRP, Kaiser Permanente Southern California, Research & Evaluation Department-Clinical Trials Division

Consenting is not just about asking patients or their Legally Authorized Representative (LAR) to sign their names on the consent form. As you have heard or read, consenting in clinical trials is an ongoing communication process with patients and/or LARs to confirm their willingness to participate and provide important study updates throughout their participation. When there are important study changes, the formal process to re-confirm and document the patient's voluntary participation under the new conditions is reconsenting.

NRG NCORP News

Patient Reported Outcomes - Compliance Improvement

Written by Kandie Dempsey and Marcie W. Ritter

NRG Patient Reported Outcomes (PRO) Compliance Officers Marcie Ritter and Kandie Dempsey have been evaluating opportunities to improve PRO data compliance. Patient Reported Outcomes (PROs) are, “a type of clinical outcome assessments based on a report that comes directly from the patient about the status of a patient's health condition without amendment or interpretation of the patient's response by a clinician or anyone else.” ⁽¹⁾ NRG trials that incorporate PROs currently use paper questionnaires sometimes supplemented by Medidata Patient Cloud (ePRO)⁽²⁾ or Visiontree⁽³⁾ electronic data capture that provides protocol participants with the ability to complete PRO surveys electronically from their personal device. Clinical Research Professionals at the research sites then can monitor data submissions in real-time to ensure the data is submitted within the protocol parameters.

Ron Chen, MD, and Stephanie Pugh, PhD discuss the importance of PROs in Clinical Trials in the interview below.

NRG Well-positions Affiliated Scholars to Compete for the Most Elite Federal Funding Opportunities!

NRG’s NCI Community Oncology Research Program (NCORP) convened a webinar to educate scholars on developing and executing R01-funded research in the NCI Community Oncology Research Program (April 11^th, 2024). NRG tailored the webinar to mid-career investigators experienced in executing single-site effectiveness studies; webinar-enhanced expertise and subsequent “R level” funding will permit more comprehensive intervention assessment in an expansive and diverse cadre of community sites. The webinar featured NRG’s most successful scholars counseling investigators in the most nuanced approaches to R01 submission uniquely tailored to address community oncology practice needs.

FORTE enrolled its 1400th participant on April 9, 2024!

Thanks to the efforts of investigators and clinical research professionals dedicated to NRG-CC005, we enrolled 115 participants in March 2024, our best month ever!

SDMC Corner

SDMC Statistics Division Welcomes Matthew Schipper, Ph.D

The NRG Oncology Statistics and Data Management Center (SDMC) is delighted to welcome Dr. Matthew Schipper to our Statistics Division. Dr. Schipper joins the SDMC from the University of Michigan, where he holds a joint appointment as the Director of Biostatistics and Bioinformatics in the Department of Radiation Oncology and as Professor in the Departments of Biostatistics and Radiation Oncology.

His research focuses on developing and applying statistical methods to improve the quality and duration of life for patients with cancer and other illnesses. Dr. Schipper’s areas of interest include statistical methods for personalized medicine, predictive risk modeling, and early phase adaptive trial designs. He is especially drawn to building predictive models for treatment efficacy and toxicity, with the goal of informing and optimizing clinical decisions for individual patients. In his role with the SDMC, Dr. Schipper will provide analytic and scientific guidance on ancillary projects involving NRG Oncology clinical trial data, participate in methodology investigations, and contribute review input on trial protocols, including design features and statistical methods. We extend a warm welcome to Dr. Matthew Schipper and look forward to his collaborations with the SDMC Statistics Division.

National Cancer Research Month

Information coming soon for the NRG Summer 2024 Meeting. Keep checking the NRG website, newsletters, email broadcasts, and social media for updates as they become available.