UPCOMING FALL VIRTUAL GROUP MEETING CONVENES NOVEMBER 4-7

The Alliance for Clinical Trials in Oncology will convene the 2020 Alliance Fall Virtual Group Meeting November 4-7. The four-day meeting expects to draw attendance from scientists, clinical research professionals, patient advocates, and others interested in the latest developments in cancer research to actively participate in interactive sessions. More than 80 disease, modality, administrative and special sessions led by distinguished oncology researchers and clinical trial specialists from across the country are scheduled. Like other meetings, this virtual 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).

To gain access to each Group meeting session, attendees must register in advance. Meeting registrants will receive an e-mail with instructions on how to download the Group meeting app, To access the web links for open sessions, registrants must log-in to either the meeting website or the phone/tablet mobile meeting app using the same credentials used to register. The web links will not be sent via e-mail or posted to the Alliance website. The website and app can also be used to browse sessions, view agendas and presentations, connect with other attendees, and more. Note: Closed sessions are by invitation only and information is not visible on the website or app.  All questions about the meeting and registration should be addressed to AllianceTravel@bwh.harvard.edu. 
 

Congratulations!
The Ohio State University Comprehensive Cancer Center
2020 Alliance Fall Virtual Group Meeting Cover Design

 

 

 
















Meeting Highlights

Here's the meeting schedule.
Continue reading below for updated meeting highlights.
Note: All times are Central Standard Time (CST).


PLENARY SESSION
Friday, November 6 | 10:30 am-12 pm

 

Welcome and Group Chair Announcements
Monica M. Bertagnolli, MD, Alliance Group Chair


 

2020 Charles G. Moertel Lecturer
Heidi Nelson, MD, FACS, is the 2020 Charles G. Moertel Lectureship Award recipient. Her lecture is entitled: "Beyond Clinical Trials." Dr. Nelson has dedicated her entire career to advancing the care of patients with colorectal cancer through clinical trials, along with the advancement of new technologies, standardization, and biologic studies -- she is considered "a true pioneer" in her field. As a world-renowned colorectal surgeon, she has provided many patients with hope and healing in addition to developing new clinical research advancements to improve cancer treatment. Her goal has been to reduce the impact of surgery on patients with early-stage disease through the safe introduction of laparoscopic and minimally-invasive surgical approaches. Dr. Nelson is the Medical Director of Cancer Programs at the  American College of Surgeons, and the Fred C. Andersen Professor of Surgery and Chair of Surgery and Colorectal Surgery at the Mayo Clinic in Rochester, MN. She is also former Program Director and Principal Investigator of the Alliance/American College of Surgeons Clinical Research Program (2011-2015). The Moertel Lecturer is an investigator whose research within the NCI National Clinical Trials Network results in a major impact on community cancer practice.

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ALLIANCE & SDMC AWARDS

2020 Richard L. Schilsky Cancer and Leukemia Group B Achievement Award
The recipient of this year’s Richard L. Schilsky Cancer and Leukemia Group B Achievement Award is Jeffrey J. Kirshner, MD, FACP, FASCO. Dr. Kirshner is Principal Investigator of Hematology Oncology Associates of Central New York and Director of Research for the HOACNY Community Clinical Oncology Program in New York. He also serves as Chair of the Alliance Data and Safety Monitoring Board and is a member of the Alliance Breast Committee, Alliance Symptom Intervention Committee, and Alliance Community Oncology Committee. He is very active in the American Society of Clinical Oncology (ASCO) where he serves on several committees, including CancerLinQ Research and Publications. He is a member of the Practice Guidelines Implementation Network (PGIN) and serves as the community oncology representative on four expert panels. Dr. Kirshner is proud to combine his passion for clinical research with the best in patient care. He has authored or co-authored more than 70 peer-reviewed research publications. 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.

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2020 Daniel J. Sargent, PhD Memorial Fellowship in Innovative Clinical Trial Design and Methods
The recipient of this year’s Daniel J. Sargent, PhD Memorial Fellowship in Innovative Clinical Trial Design and Methods is Paul J. Novotny, MS. His project is entitled: “Choice of Study Endpoints and Analysis Methods in Symptom Intervention Clinical Trials with Continuous Patient-Report Outcomes: A Monte Carlo Power Analysis and Application to Alliance CIPN and Hot Flash Clinical Trials." Mr. Novotny is an Assistant Professor of Biostatistics at the Mayo Clinic and a biostatistician who has spent more than 25 years working on clinical trials. His primary focus is on improving the quality of life of cancer patients, particularly the symptoms related to cancer and cancer treatment. The DJS Memorial Fellowship is a one-year, non-renewable term award that honors the contributions of Dr. Sargent to the field of clinical cancer research. The award is exclusively for biostatistics faculty affiliated with the Alliance Statistics and Data Management Center (SDMC), preferably junior faculty, within seven years post-training (Associate Professor Rank or below).

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2020 Alliance Scholar Awards
funding support: AbbVie



Neha Mehta-Shah, MD, MSCI
Assistant Professor of Medicine, Washington University School of Medicine
“Evaluating minimal residual disease in peripheral T-cell lymphomas being treated for curative intent in A051902”





Xiao X. Wei, MD, MAS
Instructor of Medicine, Harvard Medical School
“Impact of Immunotherapy Discontinuation on Health Economics in Patients with Advanced Urothelial Carcinoma in a Non-Inferiority Phase 3 Trial”

 

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NEW INVESTIGATORS MEETING
Primary Topic: Getting More Involved in Alliance Clinical and Translational Work
Thursday, November 5 | 9 am-1 pm

This session is geared towards new (and/or upcoming Alliance study chairs) and any Alliance member (any career level) who is interested in getting more involved in clinical and translational work of the Group. This session will be a great opportunity to learn more about the Alliance and how to be successful as an investigator.

Here's a brief agenda for the course:
-- A Welcome and Introduction from Alliance Group Chair Monica Bertagnoli, MD
-- How to Get Involved in the Alliance
-- How the Alliance Protocol Office Can Help You
-- Data Management
-- Engaging Patient Advocates
-- Alliance BioSpecimens

All slides will be available after the session to use as a resource.  It is hoped that this session will act as an informative beginning to a relationship with Alliance. Those interested in attending, please be sure to register for the 2020 New Investigators Meeting here.

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ALLIANCE NEW DRUG APPLICATION (NDA) TRIALS
Primary Topic: Alliance A021502, Alliance A021602, Alliance A041701
Thursday, November 5 | 2 pm-4 pm

This session is designed for site staff, including investigators, CRPs, and nurses, to review the Alliance New Drug Application (NDA) Trial Program. During this session, attendees will learn more about Alliance’s specific processes for NDA trials as well as currently active Alliance NDA trials, including Alliance A021502 (Randomized trial of standard chemotherapy alone or combined with atezolizumab as adjuvant therapy for patients with stage III colon cancer and deficient DNA mismatch repair), Alliance A021602 (Randomized, double-blinded phase III study of cabozantinib versus placebo in patients with advanced neuroendocrine tumors after progression on everolimus) and Alliance A041701 (A randomized phase II/III study of conventional chemotherapy /- uproleselan (GMI-1271) in older adults with acute myeloid leukemia receiving intensive induction chemotherapy). The session will also provide a brief intro to Alliance’s upcoming NDA trial, Alliance A011801 (The CompassHER2 trials (Comprehensive use of pathologic response assessment to optimize therapy in HER2-positive breast cancer) CompassHER2 residual disease (RD), a double-blinded, phase III randomized trial of T-DM1 compared with T-DM1 and tucatinib).

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INSTITUTIONAL PI WORKSHOP
Primary Topic: Challenges of Conducting Clinical Trials During the COVID-19 Pandemic
Friday, November 6 | 12 pm-2 pm

Institutional PIs and administrators are invited to attend the Institutional PI Workshop for an open discussion of the challenges of conducting clinical trials during the COVID-19 pandemic. Monica Bertagnolli, MD, Alliance Group Chair, will present some opening remarks. The Chairs of the Alliance Audit Committee, IPEC, and Membership Committee will discuss the impact of COVID-19 on performance measures. Additionally, a panel of PIs representing multiple types of members (LAPS, NCORPs, community-based and academic) from COVID-19 hotspots will address meeting attendees' questions or concerns and provide insight into best practices for overcoming these challenges and the temporary process changes implemented by the NCI. The workshop will be moderated by Daniel Nikcevich, MD, PhD, Alliance Membership Committee Chair. Panelists include Scott Tagawa, MD (NYP/Weill Cornell Medical Center), Marilyn Leitch, MD (University of Texas Southwestern Medical Center LAPS), Harold Burstein, MD, PhD (Dana-Farber/Partners CancerCare LAPS), and Phillip Stella, MD (Michigan Cancer Research Consortium NCORP). The following representatives from the NCI will be available to discuss NCI initiatives taken in response to COVID-19: Andrea Denicoff, MS, RN, ANP (Head of NCTN Clinical Trials Operations), Gary L. Smith, MT, MGA (Chief of Clinical Trials Monitoring Branch), and Sharon L. Hampp, RN, JD (Head of Strategy and Operations NCI CIRB).

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CLINICAL RESEARCH PROFESSIONALS SESSIONS    
 
The Clinical Research Professionals (CRP) Orientation (Wednesday, November 4 | 1 pm-3 pm) is targeted to CRPs within their first 18 months of oncology research or their first 18 months of NCI oncology research.  This session provides an opportunity to learn about the Alliance organizational structure, the Alliance protocol template, eligibility check best practices, CRP resources on the Alliance website, and BioMS.

CRP Breakout: Data Management Basics – Helpful Tips & Common Errors (Wednesday, November 4 | 3 pm – 4 pm)
This session is designed for CRPs entering data into Case Report Forms in RAVE. This session will review everything from data entry, critical thinking for data submission, and how to run delinquent data reports.

CRP Breakout: RECIST Workshop for your RECIST Dilemmas (Wednesday, November 4 | 4 pm- 5 pm)
This session will review RECIST guidelines presented by Scott Okuno, MD, Alliance Audit Committee Chair, and will follow with several examples of RECIST challenges sites have come across. These examples will be presented for attendees to work together to practice RECIST reporting.

CRP Breakout: Site Administrator (Wednesday, November 4 | 5 pm-6 pm)
This session will provide an opportunity for site Lead CRPs and administrators to discuss challenges and share process improvements.

The CRP Information Session (Thursday, November 5 | 12:30 pm-3 pm) will provide information to CRPs, including data managers and nurses. This session will start with a patient advocate presentation, Patient Cloud training, we will hear an update on the COVID-19 data analysis, in addition to updates from Alliance, and CTSU. 

The CRP Education Session (Friday, November 6 | 8 am-10 am) will include a presentation on Alliance A221805 (Duloxetine to prevent oxaliplatin-Induced chemotherapy-induced peripheral neuropathy: A randomized, double-blind, placebo-controlled phase II to phase III study), Alliance A171901 (Older non-small lung cancer patients (>/= 70 years of age) treated with first-line MK-3475 (pembrolizumab) +/- chemotherapy (oncologist's/patient's choice), Alliance A071702 (A phase II study of checkpoint blockade immunotherapy in patients with somatically hypermutated recurrent glioblastoma), LUNGMAP, and the recently implemented Provider Associations for Radiation.

CRP Breakout: Radiopharmaceutical Study Training (A021901 and A031801) (Friday, November 6 | 11:30 am-12:30 pm)
This session will offer an overview of radiopharmaceuticals and their role in oncology to be followed by presentations of Alliance’s two radiopharmaceutical studies, Alliance A021901 (177Lu-DOTATATE vs everolimus in SSTR+bronchial NETs) and Alliance A031801 (A phase II randomized trial of radium-223 dichloride and cabozantinib in patients with advanced renal cell carcinoma with bone metastasis (RadiCaL).

CRP Breakout: Dose Modification Workshop (Friday, November 6 | 1 pm-2 pm)
This workshop will offer overall dose modification training including how to read a protocol to identify the appropriate dose modification. This will be followed by examples of dose modifications for the attendees to work together to identify the appropriate dose modification for that situation.

CRP Breakout: COVID-19 Workflow Best Practice Roundtable Discussion (Friday, November 6 | 2:30 pm-3:30 pm) 
This session is an opportunity for sites to share what has worked as they have adapted workflows during the COVID-19 global pandemic. This will also be an opportunity for sites to ask questions and brainstorm what is working and what still needs improvements as the pandemic lingers.

CRP Breakout: Hematologic Malignancy Overview (Friday, November 6 | 4 pm-5 pm)
This session is targeted to CRPs working on hematologic studies and will give an overview of various hematologic diseases.

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ONCOLOGY NURSING SESSION 
 
Oncology Nursing Education Session

The Oncology Nursing Committee will provide the opportunity for attendees to earn CEU credit in two sessions:

Session 1: Thursday, November 5 | 1:30 pm-2:30 pm
Alliance A011801: The CompassHER2 trials (Comprehensive use of pathologic response assessment to optimize therapy in HER2-positive breast cancer) CompassHER2 residual disease (RD), a double-blinded, phase III randomized trial of T-DM1 compared with T-DM1 and tucatinib
Ciara O’Sullivan, MD, study chair, will provide an overview of the upcoming breast cancer trial utilizing tucatinib and TD-M1.

Session 2: Saturday, November 7 | 8 am-9 am
Alliance A071701: Genomically-guided treatment trial in brain metastases
Priscilla Brastianos, MD, study chair, will present an overview of this trial and invite discussion.

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ALLIANCE FOUNDATION TRIALS (AFT) SESSIONS
 
Thursday, November 5 
8:30 am-10 am
AFT Overview and Updates
 
Friday, November 6
11:30 am-12:30 pm  
AFT-25 COMET 
 
12:30 pm-1:30 pm
AFT Myeloma & Lyphoma Trials 
AFT-38 PATINA

1 pm-2pm
AFT-50 EndoMAP

1:30 pm-2:30 pm
AFT-05 PALLAS

(Sessions are closed to Alliance members only)

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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 6.5 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 32 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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ALLIANCE ON SOCIAL MEDIA   

Share your meeting experience and session highlights using the hashtag - #AllianceFall2020. Find and follow us on Twitter: @ALLIANCE_org and on Facebook at https://www.facebook.com/AllianceForClinicalTrialsInOncology/

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HELPFUL ZOOM GUIDES & TOOLS