Outside organizations

Attachment 8. Consultations Organizations Outside NCI:
Organizations Outside NCI
1. Consultations via the NCI’s Cancer Biomedical Informatics Grid (caBIG®) Program
In an effort to encourage broad community engagement in the development of the CTRP
Database, this project has been coordinated with the National Cancer Institute’s cancer
Biomedical Informatics Grid (caBIG®) program. As listed below, NCI has made numerous
presentations during caBIG face-to-face meetings and teleconference calls, all of which are
open to the public and in which the cancer research community actively participates.
Moreover, the caBIG® Clinical Trials Management Systems (CTMS) Workspace has been
regularly discussing and planning the development of this electronic infrastructure resource
since shortly after the NCI Clinical Trials Working Group (CTWG) report recommended the
establishment of the CTRP Database in June 2005 as one of four strategic informatics initiatives.
The caBIG® CTMS Workspace Steering Committee was established specifically to facilitate
strategic feedback and guidance from the biomedical research and informatics communities for
the deployment of the CTWG informatics initiatives, including the CTRP Database. This
committee is made up of members of the cancer research community, divided approximately
equally into “trialists” (e.g., investigators, statisticians, clinical trials office directors) and
“informaticists”. The CTMS Workspace Steering Committee includes members of the NCI
Cancer Center Community, the NCI Cooperative Groups and two patient advocate
representatives. NCI and FDA representatives also attend the meeting as federal observers.
The CTMS Workspace Steering Committee meets face-to-face three times yearly; NCI staff
members deliver a presentation on the CTRP Database and solicit feedback at each meeting.
Moreover, NCI recently established the CTRP Implementation Subcommittee of the CTMS
Workspace Steering Committee, which meets regularly by teleconference between quarterly
Steering Committee meetings. These meetings will allow in-depth discussions of the design,
implementation and progress of the CTRP Database.
Current members of the caBIG® CTMS Workspace Steering Committee include:
▪

Jan C. Buckner, M.D., Chair, Division of Medical Oncology, and Professor of Oncology,
Mayo Clinic College of Medicine, and Chair, North Central Cancer Treatment Group (CoChair)

▪

Sorena Nadaf, M.S., M.M.I., Director, Translational Informatics, and Chief Information
Officer, Helen Diller Family Comprehensive Cancer Center, University of California, San
Francisco (Co-Chair)
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▪

Robert P. Annechiarico, Director of Cancer Center Information Systems, Duke
Comprehensive Cancer Center

▪

James N. Atkins, M.D., Principal Investigator, Southeast Cancer Control Consortium
Community Clinical Oncology Program

▪

Rebecca J. Benner, Ph.D., Associate Director, Oncology Statistics, Pfizer, Inc.

▪

Powel H. Brown, M.D., Ph.D., Associate Professor of Medicine, and Director, Cancer
Prevention Section, Breast Care Center, Baylor College of Medicine

▪

Christopher Chute, M.D., Dr.P.H., Professor of Medical Informatics, Associate Professor
of Epidemiology and Chair, Biomedical Informatics, Mayo Clinic

▪

Walter M. Cronin, M.P.H., Executive Director, National Surgical Adjuvant Breast and
Bowel Project

▪

Sharon A. Elcombe, M.A., Systems Coordinator, Mayo Clinic Cancer Center and North
Central Cancer Treatment Group

▪

Gwen Fyfe, M.D., Vice President, Hematology and Oncology, Genentech, Inc.

▪

Robert J. Gray, Ph.D., Professor of Biostatistics, Harvard School of Public Health, and
Group Statistician, Eastern Cooperative Oncology Group

▪

Collette M. Houston, Director, Clinical Research Operations, Memorial Sloan-Kettering
Cancer Center

▪

Charles S. Hurmiz, Director, Department of Clinical Research Informatics, St. Jude
Children’s Research Hospital

▪

Charles J. Jaffe, M.D., Ph.D., Senior Global Strategist, Digital Health Group, Intel
Americas, Inc., and Chief Executive Officer, Health Level Seven, Inc.

▪

Kimberly F. Johnson, Director of Information Systems, Cancer and Leukemia Group B

▪

Roy Jones, M.D., Ph.D., Professor of Medicine, University of Texas M.D. Anderson
Cancer Center

▪

Philip W. Kantoff, M.D., Professor, Department of Medicine, Harvard Medical School,
Director, Lank Center for Genitourinary Oncology, Dana-Farber Cancer Institute, and
Associate Physician, Medicine, Brigham And Women's Hospital
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▪

Warren A. Kibbe, Ph.D., Research Associate Professor, Director of Bioinformatics, Center
for Genetic Medicine, Director of Bioinformatics, Robert H. Lurie Comprehensive Cancer
Center, Associate Director of the Northwestern University Biomedical Informatics
Center (NUBIC), Feinberg School of Medicine, Northwestern University

▪

Rebecca D. Kush, Ph.D., President, Clinical Data Interchange Standards Consortium

▪

Kevin Lewis, M.B.A., Principal, Business Technologies Group, PRTM Management
Consultants, Inc., and Board Member, Colon Cancer Alliance (patient advocate)

▪

Raymond S. Lord, M.D., Principal Investigator, West Michigan Community Clinical
Oncology Program

▪

Kristin Padavic-Shaller, R.N., M.S.N., Clinical Research Coordinator, Fox Chase Cancer
Center

▪

Electra D. Paskett, Ph.D., Associate Director for Population Science, and Marion N.
Rowley Professor of Cancer Research, Ohio State University Comprehensive Cancer
Center

▪

Diane Paul, Consumer Advocates in Research and Related Activities (patient advocate)

▪

Nicholas J. Petrelli, M.D., Medical Director, Helen F. Graham Cancer Center, Christiana
Care Health System

▪

Daniel J. Sargent, Ph.D., Professor of Biostatistics and Oncology, and Director of Cancer
Center Statistics, Mayo Clinic College of Medicine

▪

Mitchell D. Schnall, M.D., Ph.D., Matthew J. Wilson Professor of Research Radiology, and
Associate Chair of Research, Department of Radiology, University of Pennsylvania

▪

Ida Sim, M.D., Ph.D., Associate Professor, Division of General Internal Medicine,
Director, Center for Clinical and Translational Informatics, and Graduate Group Member,
Program in Biological and Medical Informatics, University of California, San Francisco

▪

Donald L. Trump, M.D., President and CEO, Roswell Park Cancer Institute

▪

Brenda K. Young, Senior Director, Clinical Operations, ACR Image Metrix, Inc., and Senior
Director of Clinical Trials Informatics, American College of Radiology

Current federal observers who participate in the caBIG® CTMS Workspace Steering Committee
include:
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▪

Jeffrey S. Abrams, M.D., Associate Director, Cancer Therapy Evaluation Program,
Division of Cancer Treatment and Diagnosis, National Cancer Institute

▪

Frank M. Balis, M.D., Head, Pharmacology and Experimental Therapeutics Section,
Senior Investigator, and Clinical Director, Center for Cancer Research, National Cancer
Institute

▪

James H. Doroshow, M.D., Director, Division of Cancer Treatment and Diagnosis,
National Cancer Institute

▪

Leslie G. Ford, M.D., Associate Director, Division of Cancer Prevention, National Cancer
Institute

▪

Lakshmi M. Grama, M.A., M.L.S., Chief, International Cancer Research Databank Branch,
Office of Communication and Education, National Cancer Institute

▪

Armando Oliva, M.D., CAPT, U.S. Public Health Service, and Deputy Director for
Bioinformatics, U.S. Food and Drug Administration

▪

Sheila A. Prindiville, M.D., M.P.H., Director, Coordinating Center for Clinical Trials,
National Cancer Institute

▪

Dianne Reeves, R.N., M.S.N, Associate Director for Biomedical Data Standards, Center
for Biomedical Informatics and Information Technology, National Cancer Institute

▪

Peggy Tucker, M.D., Director, Human Genetics Program, and Director, Human Genetics
Program, and Chief, Genetic Epidemiology Branch, Division of Cancer Epidemiology and
Genetics, National Cancer Institute

▪

Linda K. Weiss, Ph.D., Chief, Cancer Centers Branch, National Cancer Institute

▪

Jo Anne Zujewski, M.D., Head, Breast Cancer Therapeutics, Clinical Investigation Branch,
Cancer Therapy Evaluation Program, National Cancer Institute

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NCI staff members have made at least 22 presentations and solicited feedback concerning the
CTRP Database over the last 3 years at face-to-face meetings and teleconferences of various
groups participating in the caBIG initiative, as listed below:
▪

caBIG Annual Meeting: April 2006, February 2007, June 2008

▪

caBIG CTMS Workspace Meetings: December 2006, May 2007, November 2007, April
2008, September 2008, March 2009

▪

caBIG Data Sharing and Intellectual Capital Workspace Meeting: May 2007 and January
2008

▪

caBIG CTMS Workspace/Special Interest Group (SIG) Teleconferences: September
2007, May 2008,July 2008, December 2008, January 2009

▪

caBIG CTMS Workspace Steering Committee Meetings: March 2007, August 2007,
December 2007, May 2008, September 2008, December 2008, April 2009

2. Other venues for feedback and comment
NCI has regularly briefed and solicited feedback from the NCI Cancer Center Directors and other
NCI grantee groups as well as other members of the cancer research community regarding the
CTRP Database. Below is a sampling of groups to which presentations have been made:
▪

Cancer Center Administrators’ Forum Annual Meeting: March 2008, March 2009,
November 2014, April 2016, April 2017, March 2019. The Cancer Administrators Forum
is the professional association for chief administrative officers for all cancer centers that
receive NCI funding.

▪

Cancer Informatics for Cancer Centers (CI4CC): March 2015. The Cancer Informatics for
Cancer Centers (CI4CC) Symposium is a nonprofit organization that provides a focused
forum for academic focused research informatics scientists.

▪

CTRP Strategic Subcommittee: August 2010 – February 2011. The Clinical Trials
Reporting Program (CTRP) Strategic Subcommittee, co‐chaired by Dr. Kevin Cullen,
Director, University of Maryland Greenebaum Cancer Center, and Dr. Sheila Prindiville,
Director, Coordinating Center for Clinical Trials, NCI, was formed in collaboration with
members of the NCI cancer research community, leadership of NCI‐designated Cancer
Centers and the AACI. The charge of the subcommittee was to identify current and
estimated future workload and timeframe to meet CTRP information requirements for:
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1) registration; 2) accrual (summary, patient level with demographics, disease coding);
and 3) outcomes. Specific agenda topics included: 1) summary of experience with CTRP
registration; 2) review of data elements for registration, amendments, updates, accrual,
and outcomes; 3) report on the status of vendor integration and their estimates to
automate registration and accrual reporting (e.g., Forte Research Systems, Velos); 4)
timeline for adoption of reporting requirements; and 5) policy on reporting by trial type.
See the final report, Attachment 11.
▪

HMO Cancer Research Network (CRN) Annual Conference: May 2006. The CRN, a
program funded by NCI, consists of the research programs, enrolled populations, and
data systems of 14 health maintenance organizations nationwide.

▪

Onsemble Oncore User Group Conference: July 2006. A consortium of academic
medical centers that using a particular commercial clinical data management software
system to perform their day to day tasks. Members include study coordinators, data
managers, and financial coordinators. In addition, many individuals at NCI-funded
cancer centers like clinical investigators and cancer center administrators rely on the
information available through this product for their clinical research operations.

▪

National Cancer Institute Cancer Center Directors’ Retreat: May 2008, April 2018. The
NCI Cancer Centers Program supports 63 NCI-designated cancer centers nationwide that
are actively engaged in trans-disciplinary research to reduce cancer incidence,
morbidity, and mortality. The NCI-designated Cancer Centers are a major source of
discovery of the nature of cancer and of the development of more effective approaches
to cancer prevention, diagnosis, and therapy. They also deliver medical advances to
patients and their families, educate health-care professionals and the public, and reach
out to underserved populations. They are characterized by strong organizational
capabilities, institutional commitment, and trans-disciplinary, cancer-focused science;
experienced scientific and administrative leadership, and state-of-the-art cancer
research and patient care facilities. NCI-designated Cancer Centers receiving funding for:
formal research programs that foster interactions between basic laboratory, clinical, and
population scientists; access for investigators to shared services and technologies that
are necessary to their research efforts; and other scientific infrastructure.

▪

American Association of Cancer Institutes Meeting: October 2008, July 2017, July
2018. The Association of American Cancer Institutes comprises 95 leading cancer
research centers in the United States, including the National Cancer Institute-designated
centers and academic-based cancer research programs that receive NCI support
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▪

Cancer and Leukemia Group B (CALGB) Meeting: November 2008. The Cancer and
Leukemia Group B (CALGB) is a national clinical research group sponsored by the NCI,
with the Central office headquartered at the University of Chicago and the Statistical
Center located at Duke University. The CALGB is a national network of 26 university
medical centers, more than 200 community hospitals and more than 3,000 oncology
specialists who collaborate in clinical research studies. These studies aim to reduce
morbidity and mortality from cancer, relate biological characteristics of cancer to clinical
outcomes, and develop new strategies for the early detection and prevention of cancer.

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