About Us

Coordination Initiatives

• Facilitate a comprehensive clinical trials database.
• Promote collaborative team science and clinical trial cooperation.
• Develop Guidelines for joint participation of Food and Drug Administration (FDA) and NCI concerning new agents and diagnostics.
• Increase awareness of the NCI-FDA expedited concept/protocol approval process.
• Facilitate enhanced cooperation and coordination of NCI with FDA and Centers for Medicare and Medicaid Services (CMS).

Prioritization/Scientific Quality Initiatives

• Establish an Investigational Drug Steering Committee (IDSC) for the design and prioritization of early phase drug development trials with agents for which the NCI Clinical Trials Evaluation Program (CTEP) holds an Investigational New Drug (IND).
• Establish a network of Scientific Steering Committees to address, design and prioritize phase 3 trials.
• Enhance patient advocate and community oncologist involvement in clinical trial design and prioritization.
• Establish a funding and prioritization processes for correlative science and quality of life studies.
• Establish a standards development process for correlative science studies conducted in association with phase 3 trials.
• Integrate phase 2 trials into systems established by the IDSC and the Scientific Steering Committees.

Standardization Initiatives

• Promote national clinical trial information technology infrastructures that are interoperable with NCI’s Cancer Biomedical Informatics Grid (caBIG).
• Facilitate the development of standard Case Report Forms (CRFs).
• Facilitate the development of a credentialing registry for investigators and sites.
• Establish standard clauses for clinical trial contracts.

Operational Efficiency Initiatives

• Restructure the funding model for phase 3 trials to incentivize more rapid rates of patient accrual.
• Identify institutional barriers that prolong the clinical trial process and develop solutions.
• Promote patient and public awareness and understanding of clinical trials.
• Facilitate clinical trial initiation by identifying and reducing institutional barriers including acceptance of Central Institutional Review Board (CIRB) review.

Enterprise-Wide Initiatives

• Administratively support a clinical trials oversight committee to advise the NCI director on the conduct of clinical trials across the institute, Clinical Trials Advisory Committee (CTAC).
• Clinical Trials Operations Committee (CTOC) administratively support a coordinated NCI organizational structure to manage the entire clinical trials enterprise supported by the institute.

Evaluation and Outcome Measures

• Facilitate the development of an evaluation system for measuring success of CTWG initiatives.

Staff:

Director

Sheila Prindiville, MD, MPH
Email: prindivs@mail.nih.gov

Program Directors

Deborah Jaffe, Ph.D.
Email: jaffed@mail.nih.gov

LeeAnn Jensen, Ph.D.
Email: jensenl@mail.nih.gov

Ray Petryshyn, Ph.D.
Email: petryshr@mail.nih.gov

Program Specialist: Mason Schoenfeldt
Email: shoenfeldtm@mail.nih.gov

Administrative Assistant: TBN

Contact information: Coordinating Center for Clinical Trials
Office of the Director
National Cancer Institute
6120 Executive Blvd., Suite 109
Rockville, MD 20852
Phone: (301) 451-5048
Fax: (301) 480-0485
Email: NCICCCT@mail.nih.gov