UPCOMING: 2024 ALLIANCE SPRING HYBRID GROUP MEETING
























Meeting book

Congratulations to the VCU Massey Cancer Center Minority Underserved NCORP for the 2024 Alliance Spring Hybrid Group Meeting Book cover design. As an awardee of a MU-NCORP (formerly referred to as Minority Community Clinical Oncology Program) for more than 30 years, Massey plays a significant role in facilitating the development of community-based oncology clinical trial partnerships in Virginia. Asit Paul, MD, PhD, is the site principal investigator for the MU-NCORP Alliance trials. Click here to download and view the meeting book located on the Alliance member website.

What to expect

The Alliance for Clinical Trials in Oncology will convene the 2024 Alliance Spring Hybrid Group Meeting May 15-18.

The four-day meeting will host a variety of scientific and administrative sessions led by distinguished oncology researchers, clinical trial specialists, and administrators from across the country. It 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 Attendee Hub 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.
Check out a few meeting highlights below.
All times noted are Central Daylight Time (CDT).

PLENARY SESSION :: Friday, May 17, 10:30 am-12:30 pm



Welcome and Announcements

Evanthia Galanis, MD
Group Chair
Alliance for Clinical Trials in Oncology


Alliance Special Projects Allocation Awards
Presentations from Award Recipients
These projects directly address one or more Alliance strategic priorities announced in January 2023 to: 1) improve operational and trial conduct efficiencies; 2) encourage biomarker-based discovery; and 3) eliminate inequities/deliver optimal care.

“Imaging in Alliance Clinical Trials: Current Status and Future Directions”



Lawrence H. Schwartz, MD
Co-Chair, Alliance Imaging Committee
Chair, Department of Radiology, Hedvig Hricak Chair in Radiology
Memorial Sloan Kettering Cancer Center

 



Michael V. Knopp, MD, PhD
Co-Principal Investigator, Imaging and Radiation Oncology Core (IROC)
Director, IROC Ohio at the Wright Center of Innovation




“Cancer and Leukemia Group B (Alliance) Thoracic Oncology Trials: Past, Present and Future”




Thomas Stinchcombe, MD
Chair, Alliance Respiratory Committee
Professor, Department of Medicine, Duke University School of Medicine
Member, Duke Cancer Institute



**********

NEW INVESTIGATORS WORKSHOP :: Thursday, May 16 | 1 pm-4 pm
This workshop is designed to assist junior faculty find success within the Alliance community in both academic as well as community settings. Alliance Group Chair Evanthia Galanis, MD, will kick off the workshop with an overview of Alliance structure. Presentations will cover how to get involved in the Alliance from the perspective of a committee chair from John Leonard, MD, (Chair, Alliance Lymphoma Committee) and how community physicians can be encouraged to get involved by Tareq Al Baghdadi, MD.

Susan Geyer, PhD (Alliance Statistician) and Kristina Laumann (Alliance Program Manager) will discuss the Alliance Statistics and Data Management Center. Selina Chow, MD (Executive Officer, Alliance Cancer Control Program) and Yuijia Wen, MD, PhD (Senior Director, Alliance Translational Research Operations) will cover resources available within the Translational Research Program and Data Share.

Amylou Dueck, MD, and Michelle Naughton, MD (Co-Chairs, Alliance Health Outcomes Committee) will share specifics on impactful PROs. Electra Paskett, PhD (Program Director and Principal Investigator, Alliance Cancer Control Program) will cover Alliance best practices for enrolling underrepresented minority populations. The workshop will conclude with closing remarks and discussion about resources available within the Alliance Central Protocol Operations Program.

All slides will be available after the workshop for use as a resource.

**********

REGISTRATION TRIALS WORKSHOP

A021602 (CABINET) - A021502 (ATOMIC) - A031501 (AMBASSADOR)
:: Thursday, May 16 | 3 pm-4:30 pm
This interactive session is particularly relevant to ongoing efforts with two prospective new drug application (NDA) registration trials (A021602 and A021502) and one retrospective registration trial (A031501). These trials are anticipated to be filed by the trial’s pharmaceutical partners in the near future. This session is ideal for CRPs, including data managers, clinical research coordinators, regulatory coordinators, research nurses, and others who are working on these specific trials. The session will focus on assisting sites in preparing for potential health authority inspections related to these trials.

>> A021602/CABINET (Randomized, double-blinded phase III study of cabozantinib versus placebo in patients with advanced neuroendocrine tumors after progression on prior therapy
>> A021502/ATOMIC (Randomized trial of FOLFOX alone or combined with atezolizumab as adjuvant therapy for patients with stage III colon cancer and deficient DNA mismatch repair or microsatellite instability)
>> A031501/AMBASSADOR (Phase III randomized adjuvant study of pembrolizumab in muscle-invasive and locally advanced urothelial carcinoma (MIUC) vs observation)

**********

ICAREdata® RESULTS AND NEW INITIATIVES
:: Friday, May 17  | 1 pm-3 pm
The Alliance Data Innovation Lab’s efforts include validation and use of cancer data standards and technologies to collect and access data points within the site electronic health records (EHRs) for use in clinical research. ICAREdata® is the comprehensive program powered by the Data Innovation Lab that aims to Integrate Clinical trials And Real-world Endpoints. The ICAREdata initiative was successfully configured in the EHR at participating institutions. This session will discuss Data Innovation Lab projects, including adverse event reporting, ICAREdata, and the exciting new Real-World Data EHR project.

**********

PARTICIPANT ENGAGEMENT PORTAL (PEP) SESSION
:: Friday, May 17  | 3:30 pm-4:30 pm
The Alliance Participant Engagement Portal (PEP) is an innovative web-based tool that was launched by the Alliance Data Innovation Lab. PEP is used to keep clinical trial participants engaged at key touch points throughout their enrollment Alliance clinical trials. The bidirectional communication of PEP is a pillar of its functionality and capabilities. Its overarching goal is to connect trial participants to their clinical trial. This PEP session will cover how the PEP was developed and the current functionality, protocols that have partnered with PEP, and ongoing projects, including assessment of demographics and social determinants of health through patient reported surveys.

**********

CLINICAL RESEARCH PROFESSIONALS SESSIONS    

Clinical Research Professionals (CRP) Information Session :: Thursday, May 16 | 1 pm-3pm
This session is aimed at clinical research professionals and will explore significant updates across various aspects of clinical research. Jen Dill, CCRP, Chair of the Alliance Clinical Research Professionals Committee, will moderate the session, featuring a patient advocate presentation from Alliance Patient Advocate Julie Krause, an introduction of Brandy Heckman-Stoddard, PhD, MPH, Acting Director of the NCI Community Oncology Research Program (NCORP), and the latest PMB/Aurora Updates from Kayla Dye, PharmD, Senior Clinical Research Pharmacist at the NCI Pharmaceutical Management Branch.

The session will also feature CTSU Updates from Rachel Albershardt, MS, CCRP, OPEN Team Lead at Westat/Clinical Trials Support Unit, covering essential topics such as DTL Updates, Protocol Deviation Version 2, Serious Adverse Events FAQs, ID.me, and staff training resources like CLASS, along with other helpful CTSU resources. Colleen Watt, Director of Protocol Operations will bring updates from the Alliance Chicago Office, highlighting operational strategies and updates. Concluding the session, Kristina Laumann, Program Manager, and Elizabeth Snow, MA, Director of Data Management, both from the Alliance Statistics and Data Management Center, will present the latest statistical and data management updates, ensuring attendees are well-informed on the latest trends and resources in clinical research.

Alliance CRP: Round Table Discussions :: Thursday, May 16 | 3:30 pm-5:30 pm
This session is specifically tailored for clinical research professionals and promises to be a dynamic platform to exchange knowledge and provide networking opportunities. Subject matter experts dive into specialized topics ranging from data management, regulatory compliance, protocol coordination, audits, and much more. Whether you're interested in the intricacies of FDA registration trials or the nuances of the Clinical Trial Support Unit (CTSU) platform, this session will offer a valuable opportunity to connect with peers, discuss challenges, and share solutions. New and experienced CRPs alike, will find a welcoming environment for learning and continued growth.

Clinical Research Professionals (CRP) Education Session :: Friday May 17 | 8 am-10 am
This session, pivotal for those involved in the operational, clinical, and pathological aspects of research, will feature in-depth discussions on the ComboMATCH/EAY191-A3 and A6 trials, with timing nuances explored by Allison Booth, MS. Alliance Clinical Research Professionals Committee Chair Jen Dill, CCRP, will provide valuable insights into the Research Operations Initiative, offering an enhanced understanding of current research practices. Gloria Sura, MD, will delve into the critical distinctions between clinical and pathological staging, including implications for trial outcomes and patient care. Dr. Sura will also offer guidance on understanding the complexities of molecular reports. This session aims to empower CRPs with the confidence and skills to excel in their roles, contributing to the advancement of clinical research and the betterment of patient care.

CRP Breakout Session: New CRP Welcome :: Friday May 17 | 1 pm-2 pm
This is an essential introduction designed to orient new clinical research professionals (CRPs) within the Alliance community. This session, led by Erinn McDonnell, MS, CCRP, and Jason Atkinson, CCRP, is crafted to ensure a smooth transition into CRP role, offering a comprehensive overview of available valuable resources. The session will delve into the depths of both Alliance and Clinical Trials Support Unit (CTSU) websites, showing where to find the tools, documents, and guidance necessary to support a career in clinical research. Whether you're seeking study protocols, regulatory guidelines, training materials, etc., this session promises to equip CRPs with the knowledge to navigate Alliance platforms efficiently. This is an excellent opportunity for new CRPs to acquaint themselves with the wealth of resources at their fingertips, setting the foundation for a successful career in clinical research.

CRP Breakout Session: BioMS Intro :: Friday May 17 | 2:30 pm-3:30pm
This session, led by Melissa McKenna, is designed to provide CRPs with an in-depth introduction to the Alliance BioSpecimen Management System (BioMS), which is a critical tool in the management and oversight of biological samples within clinical trials. Participants will gain a comprehensive understanding of BioMS functionalities, best practices for navigating the system, and insights into how BioMS integrates with broader clinical research operations. Whether you're new to BioMS or looking to refresh your knowledge, this session will equip you with the necessary skills to efficiently manage biospecimen samples, ensuring compliance and enhancing the quality of your research studies. Don't miss this opportunity to enhance your expertise and contribute to the success of your clinical trials.

CRP Breakout Session: BioMS Advanced :: Friday May 17 | 3:30 pm-4:30pm
Dive deeper into the complexities of the BioSpecimen Management System (BioMS) with this Advanced BioMS session tailored for those looking to master the more intricate aspects of this essential clinical research tool. Led by Melissa McKenna, this advanced session is designed to explore the sophisticated query features of BioMS, providing detailed guidance on managing overdue specimens, tracking all collected specimens at your site, reviewing all specimens collected for a specific patient, and editing shipments within BioMS.

This session is perfect for Clinical Research Professionals (CRPs) who are already familiar with the basics of BioMS and are ready to tackle more complex scenarios that arise in the management of biological samples. Attendees will learn to leverage BioMS's advanced functionalities to enhance their site's efficiency, ensure compliance, and improve the overall management of specimen data. Whether you're looking to refine your skills or solve specific challenges, this advanced session promises to deliver valuable insights and practical solutions.

**********

ONCOLOGY NURSING + CLINICAL RESEARCH PROFESSIONALS

Oncology Nursing Education Session :: Thursday, May 16 | 9:30 am-11:30 am
This session will feature updates in breast cancer therapy and a discussion about related Alliance clinical trials. The session will also include an overview of the latest updates in pancreatic cancer and rare GI malignancies, along with updates and rationale for Alliance A022106 (Phase II/III second-line NABPLAGEM vs. nab-paclitaxel/gemcitabine in BRCA1/2 or PALB2 mutant metastatic pancreatic ductal adenocarcinoma (PLATINUM)). In addition, the session will focus on updates in head and neck cancer and discuss Alliance A092105 (Randomized phase 2 study of nivolumab and ipilimumab with or without cabozantinib in patients with advanced nasopharyngeal carcinoma that have progressed after platinum treatment and immunotherapy), which is currently open. Nursing and SOCRA credits will be provided for this session.

Oncology Nursing/CRP Open Forum :: Thursday, May 16 | 11:30 am-12:30 pm
Calling all CRPs and Research Nurses to attend this open forum to discuss changes in oncology research, challenges.  This is an opportunity to find out how other sites are addressing challenges and to share with how your site is handling recent changes in oncology research.

**********

ALLIANCE FOUNDATION TRIALS (AFT) SESSIONS
 
Thursday, May 16
10 am-11 am :: AFT-38 PATINA
2:30 pm-3:30 pm :: AFT GU Studies - AFT-19 and AFT-47
4 pm-5 pm :: AFT-65 ASCENT-05/OptimICE-R
5 pm-5:30 pm :: AFT-58 Harmonia
5:30 pm-6 pm :: AFT-66-CAMBRIA-2

Friday, May 17
1 pm-2:30 pm :: Alliance Foundation Trials (AFT) Overview and Updates
2 pm-3 pm :: AFT-25 COMET
3:30 pm-4:30 pm :: AFT-50 EndoMAP

**********

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. 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. To receive SoCRA credit, attendees must complete a required survey e-mailed to them after the meeting.

For more information about continuing education credits, contact Katherine Stanaszek (Alliance Training and Adminsitrative Coordinator) at kstanaszek@alliancenctn.org

**********

Join the Conversation :: ALLIANCE ON SOCIAL MEDIA   

Share your meeting experience and session highlights using the hashtag - #AllianceSpring24.
Find and follow us on X (formerly Twitter): @ALLIANCE_org and on Facebook at https://www.facebook.com/AllianceForClinicalTrialsInOncology/

 

 

Read more news briefs from this issue: