UPCOMING: 2024 ALLIANCE FALL HYBRID GROUP MEETING
Meeting book
Congratulations to the Memorial Sloan Kettering Cancer Center (MSK) for the 2024 Alliance Fall Hybrid Group Meeting Book cover design. Darren Feldman, MD, is the Principal Investigator of the NCTN LAPS Grant. For more than three decades, U.S. News & World Report has consistently recognized MSK as one of the top 2 cancer hospitals in the nation. The people of MSK are united by a singular mission: ending cancer for life. MSK’s specialized care teams provide personalized, compassionate, expert care to patients of all ages. Informed by basic research done at the Sloan Kettering Institute, scientists across MSK collaborate to conduct innovative translational and clinical research that is driving a revolution in our understanding of cancer as a disease and improving the ability to prevent, diagnose, and treat it. MSK is dedicated to training the next generation of scientists and clinicians, who go on to pursue the mission at MSK and around the globe. MSK is one of the world’s most respected comprehensive centers devoted exclusively to cancer. Click here.
What to expect
The Alliance for Clinical Trials in Oncology will convene the 2024 Alliance Fall Hybrid Group Meeting October 30-November 1.
Group Chair Dr. Evanthia Galanis will welcome distinguished oncology researchers, clinical trial specialists, and administrators from across the country to the three-day meeting that will take place in Chicago and online. The meeting will showcase novel and innovative cancer control, prevention, and treatment trials conducted by investigators through a multidisciplinary academic and community research network, as part of the NCI National Clinical Trials Network (NCTN) and Community Oncology Research Program (NCORP).
All attendees must register in advance to attend the meeting and to gain virtual access to each Group meeting session. As a reminder, registrants must log in to the meeting website/app using the same credentials used to register to access and browse open sessions, view agendas and presentations, connect with other attendees, and more. Note: Closed sessions are by invitation only and information will not be visible on the website/app. For meeting and registration questions, please e-mail Meetings@AllianceNCTN.org.
Take a closer look.
Plan accordingly. View the meeting schedule.
Below are a few meeting highlights.
All times noted are Central Standard Time (CST).
PLENARY SESSION :: Friday, November 1, 10 am-12:30 pm
Welcome and Group Chair's Report
Evanthia Galanis, MD
Group Chair
Alliance for Clinical Trials in Oncology
Guest Lecturers | Annual Awards
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24 Charles G. Moertel Lecture | Plenary Lecture
Monica M. Bertagnolli, MD
Director, National Institutes of Health
The Moertel Lecture honors the legacy of Dr. Moertel, founder of the North Central Cancer Treatment Group (NCCTG), and acknowledges individuals making a major impact on community cancer practice. The award was established in 1995 through the Moertel Lecture Endowment Fund. This year's award recipient is Monica M. Bertagnolli, MD, who leads the world’s largest funder of biomedical research. Dr. Bertagnolli has led a career as a physician-scientist at Brigham and Women’s Hospital and the Dana Farber Cancer Institute, where she was chief of surgical oncology for 10 years. As a researcher, she ran an NIH-funded tumor immunology lab studying how inflammation drives colon cancer in mice. The work led to a landmark clinical trial testing whether anti-inflammatory drugs called COX-2 inhibitors can prevent precancerous colon polyps in people prone to these growths. Dr. Bertagnolli is the Founding Group Chair of the Alliance for Clinical Trials in Oncology. Two years ago, she became the first woman to lead the National Cancer Institute.
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24 Richard L. Schilsky Cancer and Leukemia Group B Achievement Award | Plenary Lecture
Richard M. Goldberg, MD
Associate Group Chair, Alliance Cancer Center Collaborations
The RLS CALGB Achievement Award was established in 2010 to recognize the 15-year tenure of Dr. Schilsky as Group Chair of Cancer and Leukemia Group B (CALGB). The award acknowledges the significant contributions of an individual to cooperative group research. This year's award recipient is Richard M. Goldberg, MD, an international leader in gastrointestinal cancer treatment and research. Dr. Goldberg has served in leadership and academic roles at OSU’s James Cancer Hospital, North Carolina Cancer Hospital, OSU and UNC Comprehensive Cancer Centers, and as a consultant and co-chair at Mayo Clinic. His research has focused on defining new treatments, elucidating inherited cancer susceptibility, and identification of predictive and prognostic factors in GI cancers, with a focus on colorectal cancer. He conducted the NCCTG N9741 trial that led to the licensing of oxaliplatin in the U.S. for the treatment of colorectal cancer. His extensive research in gastrointestinal oncology has significantly advanced the understanding of colorectal cancer and has directly influenced clinical practice guidelines.
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Daniel J. Sargent, PhD Memorial Fellowship in Innovative Clinical Trial Design and Methods
“Developing an App to Conduct Sample Size Re-Estimation Calculations for Cluster-Randomized Trials”
Heather J. Gunn, PhD
Assistant Professor / Senior Associate Consultant I
Department of Quantitative Health Sciences, Mayo Clinic Arizona
The Sargent Fellowship is an annual award established to support biostatistics faculty working closely with the Alliance and Alliance Statistics and Data Management Center research agenda. This fellowship honors the contributions of Dr. Sargent to the field of clinical cancer research. Heather J. Gunn, PhD, is the recipient of this year’s fellowship. Dr. Gunn' s primary methodological interest lies in measurement invariance and her substantive interest lies in evaluating prevention and intervention studies. She recently developed four effect size measures of measurement non-invariance and has created benchmarks for those effect sizes. The range of acceptable non-invariance values has been called the Gunn range. For her fellowship proposal, Dr. Gunn aims to create an online application tool that can conduct sample size re-estimation procedures for cluster-randomized trials for different types of endpoints and contexts and to develop a tutorial on how to use it so it can easily be implemented for clinical trials conducted by the Alliance.
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23rd ANNUAL JIMMIE HOLLAND LECTURE :: Thursday, October 31, 11:30 am-12:30 pm
“Capturing Patients’ Voices in Clinical Trials Research and Application”
Michael Brundage, MD, MSc
Emertius Professor in Departments of Oncology and Public Health Sciences
Queen's University
Sponsored by the Alliance Health Outcomes Committee, the Jimmie Holland Lecture was established to honor Dr. Holland’s contributions to the field of psycho-oncology in the CALGB/Alliance. Those receiving this honor have demonstrated notable contributions in psycho-oncology, contributing to Dr. Holland’s legacy. Michael Brundage, MD, MSc, is the recipient of this year’s lectureship. Dr. Brundage's research program resides primarily within the Division of Cancer Care and Epidemiology at Queen's Cancer Research Institute, an applied research unit that he heads. He has implemented the first Canadian Patterns of Care Study in prostate cancer radiotherapy. His work with psychologist Dr. Deb Feldman-Stewart addresses information provision and decision support for cancer patients. With regard to health-related quality of life (HRQL) and other patient reported outcomes (PROs), Dr. Brundage has worked to explore new methods of appropriately assessing and interpreting these outcomes in cancer clinical trials, as well as new ways of effectively communicating these outcomes to patients and clinicians.
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INAUGURAL ALLIANCE RESEARCH INTEGRITY SERVICE EXCELLENCE AWARD :: Thursday, October 31, 1 pm
"A Well Coordinated Journey: Applying Excellence in Clinical Research"
Denise M. Theiler, MSN, RN, CHPN, OCN
Lead Clinical Research Nurse
Office of Research Administration, Hackensack Meridian Health Research Institute
Clinical research professional (CRP) staff are integral to the success of the Alliance mission, providing clinical trial participants with the best service possible at Alliance participating sites. In recognition of their outstandong service, the Alliance has introduced the annual Research Integrity Service Excellence (RISE) Award for CRPs. Alliance aims to celebrate site CRPs who exemplify excellence through quality, advocacy, professional development and leadership with compassion, integrity, respect, safety, and teamwork. This award is all about celebrating excellence in clinical research, and Denise Theiler embodies that spirit. Her exceptional commitment to patient care, dedication to professional growth, and leadership and advocacy efforts have made a real difference. She lives the values of quality, integrity, and teamwork every day, and her contributions have been vital in advancing Alliance clinical trials.
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THE WORTA MCCASKILL-STEVENS, MD, MS HEALTH DISPARITIES SYMPOSIUM :: Friday, November 1, 8 am-10 am
"Improving Accrual of Underrepresented Populations to Clinical Trials: Lessons from the Field”
Marvella Ford, PhD - Moderator
SmartState Endowed Chair, Cancer Disparities
Associate Director, Population Sciences and Cancer Disparities
Medical University of South Carolina Hollings Cancer Center
The Alliance Health Disparities Education and Training Workgroup will host its annual symposium to highlight important considerations for successful accrual of underrepresented populations to clinical trials and share ideas applicable in both academic medical center and community hospital settings. Session speakers will present a brief overview of unique aspects to consider when presenting clinical trial information to potential participants, as well as successful strategies for accrual based on first-hand experience, followed by a panel discussion with Alliance Health Disparities Committee patient advocates, the moderator, and the audience. Strategies to enroll African American, rural Hispanic patients, enrollment of American Indian and Asian participants among other important populations, including digital engagement strategies, will be addressed at this session.
Speakers include:
"Leveraging Institutional Community Outreach and Engagement (COE) Infrastructure to Increase Accrual of African Americans to Cancer Clinical Trials"
Chiranjeev Dash, MBBS, PhD, MPH, Georgetown University Lombardi Comprehensive Cancer Center
"Accruing Rural Hispanic Patients to Clinical Trials"
Gary Unzeitig, MD, Doctors Hospital of Laredo
"Digital Engagement Strategies to Accrue Underrepresented Patients to Clinical Trials"
Erik Harden, MA, DrPH Candidate, Columbia University Medical Center
"Enrolling Native Americans in Clinical Trials: What Has Worked at Our Site"
Denise Garza, RN, BSN, OCN, University of Oklahoma, Stephenson Cancer Center
"Enrolling Asian Patients into Clinical Trials: Perspectives from Flushing, NY"
Kellie Jack, MPH, Weill Cornell Medicine Meyer Cancer Center
"Lessons Learned from the Pacific Islands"
Jeffrey Berenberg, MD, MACP, University of Hawaii Cancer Center, Hawaii MU NCORP
"From Rural Roads to Research Trials: Boosting Patient Accrual in Ohio’s Underserved Communities"
Swati Bhanja, MD, MHA, Columbus NCORP
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CLINICAL RESEARCH PROFESSIONALS SESSIONS
The CRP Information Session (Thursday, October 31, 1 pm-4 pm) will offer an array of specialized topics designed to enhance the expertise of clinical research professionals involved in oncology clinical trials. Jennifer Dill, CCRP, Chair of the Alliance Clinical Research Professionals Committee, kicks off the session, followed by key updates from NCI's Andrea Denicoff, RN, MS, ANP, Head of NCTN Clinical Trials Operations, and a review of upcoming PROSPECT Lung trial (CTIU2317-A082304-S2402) from Allison Booth, Statistical Programmer - Alliance SDMC, and Shauna Hillman, MS, Co-Director of the System & Integration Support Unit - Alliance SDMC. Colleen Watt, Director of Alliance Protocol Operations, and Todd Kennedy, Alliance Patient Advocate, will present respective updates. The session's final hour will include a panel discussion on Becoming a Lifer - CRP Career Paths where experienced CRPs and other industry professionals share and offer helpful insights. This session is designed to keep CRPs informed on the latest developments and trends in the field of cancer clinical research and is an excellent opportunity for CRPs to gain inspiration and practical advice to advance their careers.
Clinical Research Professionals Education Breakout Sessions
Wednesday, October 30
CRP Breakout: Airing Dirty Laundry :: 3 pm-4pm
This session offers a candid discussion on errors made, how to mitigate them and training strategies to avoid similar errors. Led by Betsy Barnick, MHS, CCRP (Carle Foundation Hospital) and Carol Sweney CCRP (Aurora Health Care), this session will walk-through real-life examples of audit findings and site errors everything from DTL, consenting, data management to treatment and sample submission errors. The session is designed to provide a safe space for CRPs to share their experiences, mistakes, and identified solutions. Attendees will leave with practical advice and strategies to know how to handle and prevent errors of clinical research, fostering a more efficient and supportive research environment.
CRP Breakout: Pathology for the CRP: Baseline Data Focus :: 4:30 pm-5:30pm
Led by Cornelia Ding, MD (University of California San Francisco), this session will delve into how to read and understand pathology reports for data submission. Attendees will learn to understand the sections of a pathology report and what to look for in a pathology report for data submission. This session is ideal for CRPs seeking to enhance their understanding of pathology for eligibility and data submission.
Thursday, October 31
CRP Breakout: Regulatory for FDA Registration Studies :: 8 am-9 am
Erin Lynch MS, CCRP (Medical College of Wisconsin Cancer Center), will lead this session focused on the regulatory requirements and challenges associated with FDA registration studies. Attendees will gain a deeper understanding of FDA expectations, critical steps in regulatory submissions, and how to maintain compliance throughout the study lifecycle. This session is particularly beneficial for CRPs involved in FDA registration trials, offering practical tips for managing the regulatory process effectively.
CRP Breakout: Optimizing Clinical Research Data Entry: Techniques, Tools, and Best Practices :: 9:30 am-10:30 am
Led by Jason Atkinson, CCRP (Washington University in St. Louis), and Lizzy Snow, MA, this session will explore the best practices for entering data into RAVE. The session will also include a practical walkthrough of resources and tools available to ensure data submission success, how to create helpful source documents, and how to handle errors when they occur. Attendees will leave equipped with techniques to optimize data entry, improve accuracy, and enhance the overall quality of their research data.
CRP Breakout: Genetic Counseling for Clinical Research Professionals :: 1 pm-12 pm
Led by Julia Cooper, MS, CGC (Ohio State College of Medicine), this session will introduce CRPs to the role of genetic counseling in clinical research. Attendees will gain an understanding of what is contained in a genetic report and how genetic counseling can impact patients. This session is perfect for CRPs looking to expand their knowledge in this increasingly important area of clinical research.
Friday, November 1
CRP Breakout: Adverse Event (AE) Terms and Definitions Form Training :: 8 am-10 am
Stephanie Couch, Alliance Associate Director of Quality, will provide a 40-minute training on the critical aspects of adverse event (AE) reporting in clinical trials, followed by a discussion on the closing of the Alliance A151216 (ALCHEMIST) trial by Colleen Watt, Director of Alliance Protocol Operations, and Kathryn Kelley, MPH, Alliance Protocol Coordinator, and a comprehensive overview of lymphoma by Nancy Bartlett, MD (Washington University School of Medicine in St. Louis). This session is crucial for CRPs who need to stay up-to-date on AE reporting and the latest developments in clinical research.
CRP Breakout: BioMS Overview :: 12:30 pm-1:30 pm
Clinical Informaticist Amy Brink (Washington University) will lead an in-depth session on the BioSpecimen Management System (BioMS), providing CRPs with a thorough understanding of how to manage biospecimens within clinical trials. This session will cover BioMS functionalities, best practices, and integration with broader research operations. This is an essential session for CRPs looking to enhance their expertise in biospecimen management and contribute to the success of their clinical trials.
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ONCOLOGY NURSING + CLINICAL RESEARCH PROFESSIONALS
Thursday, October 31
Oncology Nursing / CRP Open Forum :: 11:30 am-12:30 pm
This forum will offer an open platform for clinical research professionals and research nurses to discuss changes and challenges in oncology research, along with sharing best practices for addressing the issues.
Oncology Nursing Education Session :: 3:30 pm-5:30 pm
This session will feature presentations on bispecific monoclonal antibodies by Heidi Finnes, PharmD, BCOP, FHOPA (Mayo Clinic), the Janus Rectal Cancer Trial and Optimizing Response in Locally Advanced Rectal Cancer by J. Joshua Smith, MD, PhD (Memorial Sloan Kettering Cancer Center), and the MODERN trial (Alliance A032103) from Study Chair Matthew Galsky, MD (Mount Sinai School of Medicine).
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PARTICIPANT ENGAGEMENT PORTAL (PEP) :: Thursday, October 31, 9 am-10 am
Learn more about the Alliance Participant Engagement Portal (PEP) - an innovative digital health platform with the overarching goal of connecting trial participants to their clinical trial. PEP focuses on empowerment of Alliacne clinical trial particiupants across all demographics and populations. Through engagement with participants in selected trials, PEP learns from their journey to help researchers help other patients. In this session, PEP staff will present information on how PEP can help trial participants and study teams, highlight recent PEP results, and explain how to collaborate with PEP.
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ICAREdata®: RESULTS & NEW INITIATIVES :: Thursday, October 31, 10:30 am-11:30 am
ICAREdata® is the comprehensive program powered by the Alliance Data Innovation Lab that aims to Integrate Clinical trials And Real-world Endpoints in oncology research. This session will discuss Data Innovation Lab projects including results from ICAREdata, the new mCODE project and the exciting new Real-World Data EHR project - ICAREdata-LESS!
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ALLIANCE FOUNDATION TRIALS (AFT) SESSIONS
Thursday, October 31
8:30 am-9:30 am :: AFT-38 PATINA
Friday, November 1
8:30 am-10 am :: Alliance Foundation Trials (AFT) Overview and Updates*
12:;30 pm-1:30 pm :: AFT-25 COMET
12:30 pm-1:30 pm :: AFT-50 EndoMAP
4 pm-5 pm :: AFT-58 HARMONICA
4 pm-4:30 pm :: AFT-65: ASCENT-05/OptimICE-R
4:30 pm-4:30 pm :: AFT-66 CAMBRIA-2
(Sessions are closed to Alliance members only except where noted with *)
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CONTINUING EDUCATION CREDITS
RN, OCN, ARNP - ONA Credit
The Ohio Nurses Association (ONA) is the largest approver unit of CE credit in the country, accredited by the American Nurses Credentialing Center's Commission on Accreditation.
- A total of 9 contact hours have been submitted for approval.
- To receive ONA credit, attendees must complete a required survey e-mailed to them after the meeting.
CCRP - SoCRA Credit
The Society of Clinical Research Associates (SoCRA) provides training, continuing education, and an internationally recognized certification program that promotes quality clinical research to protect the welfare of research participants and improve global health.
- A total of 34 credit hours will be offered, including concurrent sessions, at this meeting.
- To receive SoCRA credit, attendees must complete a required survey e-mailed to them after the meeting.
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Join the Conversation :: ALLIANCE ON SOCIAL MEDIA
Share your meeting experience and session highlights using the hashtag - #AllianceFall24. Find and follow us on X (formerly Twitter): @ALLIANCE_org and on Facebook at https://www.facebook.com/AllianceForClinicalTrialsInOncology/
