Herbert Irving Comprehensive Cancer Center
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HICCC

Clinical Trials:

The key to finding new and better treatments for cancer lies in research. Herbert Irving Comprehensive Cancer Center (HICCC) researchers and physicians are dedicated to understanding the biology of cancer and to applying that knowledge to the design of cancer therapies and prevention strategies that reduce its incidence and progression and improve the quality of the lives of those affected by cancer. Patient participation in clinical trials is an essential factor in this process. All cancer treatments used today began with research that became clinical trials. Clinical trials test treatments for safety and effectiveness in patients, playing an important role in advancing cancer research from the laboratory to the development of new cancer treatments.

 

Click here to view the Cancer Center's clinical trials online search tool.

 

Clinical Protocol & Data Management (CPDM) Office

The CPDM provides management and oversight functions for coordinating, facilitating, and reporting on the cancer clinical trials of the institutions that define the Center, whatever the study origin (local, industrial, NCI National Clinical Trial Network, or other). The CPDM provides infrastructure and administrative oversight of the Center's clinical research program and complements the Protocol Review and Monitoring Committee (PRMC). It also provides a central location for cancer protocols, a centralized database of protocol-specific data (Velos), and an updated list of currently active protocols for use by Center investigators, including status reports of protocols. Quality control functions include centralized education and training services for clinical research nurses, clinical research and regulatory coordinators; study activation (timeline tracking); CPDM resource-allocation review; general oversight and leadership; patient accrual reporting; and a compliance core, which is responsible for central registration (including eligibility review), monitoring (institutional trials), and integration with the Data and Safety Monitoring Committee (DSMC) as non-voting members to ensure data integrity, while promoting patient safety. To review the Cancer Center's Data and Safety Monitoring Plan, click here.

CPDM Services

The CPDM is a centralized office composed of well-trained regulatory, financial, clinical, study management, and compliance personnel who promote uniformity and consistency in clinical research by providing support for principal investigators and patients. Clinical research nurses and clinical research coordinators have regular assignments with HICCC investigators and disease-specific research teams to build expertise in particular areas of oncology. CPDM personnel actively participate in disease-specific research in progress meetings, where:

  • Trials pending activation are presented and prioritized.
  • Patients in screening, active treatment, and/or long term follow-up are reviewed.
  • Potential study patients are identified.
  • Regulatory and/or other clinical research items are discussed to increase accrual, ensure patient safety, ensure regulatory compliance and promote teamwork, organization, and communication.

The CPDM allows for efficient and organized staff development and training, timely activation of clinical research protocols, optimal screening and recruitment of patients, data collection and submission, and quality control and compliance oversight.

Leadership:

  • Medical Director: Andrew Lassman, MD
  • Director of Clinical Research Operations: Brad Bott
  • Research Nurse Managers: Frances Brogan and Julia Forman
  • Clinical Research Managers: Dayna Leis, Kevin Zikaras, and Ramona Jayasena
  • Regulatory Manager: Barbara Santiago
  • Compliance Manager: Daniel Otap
  • Finance Manager: Daniel Sullivan

Contact information:

Clinical Protocols and Data Management Office
Brad Bott, MBA, CCRP
Director, Clinical Protocol & Data Management Office
Columbia University Medical Center
Herbert Irving Comprehensive Cancer Center
161 Fort Washington Ave.
Herbert Irving Pavilion
Mezzanine Level, M-207
New York, NY 10032
Phone: (212) 304-5605
bb2635@cumc.columbia.edu

Clinical Trials
Tasha Isles Smith, MA, MPH
PRMC/DSMC Manager
Herbert Irving Comprehensive Cancer Center
Columbia University Medical Center
Phone: (212) 851-4880
ts2257@columbia.edu


Columbia University Minority Based Community Clinical Oncology Program

The Herbert Irving Comprehensive Cancer Center (HICCC) of the Columbia University Medical Center (CUMC) is located in northern Manhattan, New York.  In our neighborhood, which is 71% Hispanic and 14% Black, 31% of residents are living below the poverty level, and cancer is the leading cause of years of potential life lost. Our challenge is therefore to develop the science and the services to prevent, control, and treat cancer in our community.  The CUMC MB-CCOP provides management and oversight functions for coordinating, facilitating, minority participant recruitment and retention, and reporting on the NCI-sponsored cooperative group cancer clinical trials, in conjunction with the Clinical Protocol & Data Management (CPDM) Office and the Research Recruitment and Minority Outreach (RRMO) program. Our specific objectives, like those of the NCI’s Minority Based-Community Clinical Oncology Program (MB-CCOP) are:

  • To attract and educate potential study participants, especially minorities and the underserved, about participation in state-of-the-art cancer clinical research;
  • To keep participants engaged in their clinical studies and inform them of research results;
  • To provide a menu of NCI-sponsored Clinical Cooperative Group trials to our investigators, including those in the local medical community, for screening, prevention, cancer control, and treatments;
  • To establish close relationships with the newly restructured NCI Clinical Cooperative Groups to enhance the benefits of clinical research.

CUMC MB-CCOP Services

The CUMC MB-CCOP is affiliated with the Southwest Oncology Group (SWOG), Children’s Oncology Group (COG), NRG Oncology (National Surgical Adjuvant Breast and Bowel Project (NSABP), the Radiation Therapy Oncology Group (RTOG), and the Gynecological Oncology Group (GOG), Alliance for Clinical Trials in Oncology (American College of Surgeons Oncology Group (ACOSOG), the Cancer and Leukemia Group B (CALGB), and the North Central Cancer Treatment Group (NCCTG) and SunCoast NCI-sponsored clinical trials cooperative groups. The program provides support through a U10 grant from the NCI Division of Cancer Prevention (DCP) to promote participation for minority and non-minority participants on clinical trials for treatment and for cancer prevention and control. Specific services include:

  • Regulatory coordinator support for protocol activation
  • Research nursing
  • Clinical research coordinator support for data management
  • Translation of study consent forms
  • Support for travel to NCI-sponsored cooperative group research meetings
  • Recruiter support for studies with anticipated high rates of participation among minority groups

 

View our recent news and blog here.

Leadership

  • Principal Investigator: Kara Kelly, MD
  • Co-Principal Investigator: Andrew Lassman, MD
  • Program Administrator: Brad Bott

Contact information:

Clinical Protocols and Data Management Office
Brad Bott, MBA, CCRP
Director, Clinical Protocol & Data Management Office
Columbia University Medical Center
Herbert Irving Comprehensive Cancer Center
161 Fort Washington Ave.
Herbert Irving Pavilion
Mezzanine Level, M-207
New York, NY 10032
Phone: (212) 304-5605
bb2635@cumc.columbia.edu

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