Neely Center for Clinical Cancer Research

About

The Neely Center for Clinical Cancer Research (NCCCR) is the core clinical trial facility for the Cancer Center, dedicated to coordinating all aspects of oncology and hematology clinical research in compliance with National Institutes of Health (NIH) rules, Food and Drug Administration (FDA) regulations and “Good Clinical Practice” guidelines.  
In operation since January 2003, the NCCCR supports all aspects of cancer clinical research through multiple initiatives:

  • Facilitating consideration of and start-up for new cancer clinical trials
  • Managing formal consideration and approval of all proposed clinical trials through Cancer Center Protocol Review Monitoring Committee (PRMC) review
  • Facilitating IRB submission after PRMC approval
  • Developing comprehensive cancer clinical trial research budgets
  • Supporting research investigators in active management of all trial
  • Integrating research with clinical care through active connections with clinical staff
  • Collecting and managing clinical research specimens
  • Building clinical research protocols within the cancer EMR
  • Maintaining the clinical trials management system for cancer clinical trials
  • Developing and maintaining disease-specific clinical trial rubrics for research PIs
  • Working with PIs and sponsors on all regulatory and audit requirements
  • Maintaining cooperative group memberships
  • Supporting implementation of cancer clinical trials across Tufts Medicine
  • Providing access to the National Cancer Institute's network of clinical trials testing new ways to screen, prevent, diagnose, and treat cancer
Clinical trials

Tufts Medical Center’s clinical trials program has conducted cancer clinical trials for over four decades.

The Neely Center for Clinical Cancer Research (NCCCR) coordinates and oversees all cancer trials at Tufts Medical Center. The NCCCR maintains a registry of all trials, ensures institutional credentialing, provides continuing education and training, monitors accrual and data, and summarizes and publicizes trials.

The NCCCR’s mandate includes developing and implementing Tufts MC’s investigator-initiated clinical trials, National Cancer Institute (NCI)–sponsored cancer clinical trials, supporting Tufts MC’s role within the ECOG-ACRIN cancer research group and other cooperative groups, and supporting and developing industry-sponsored trials that are programmatically important for the various clinical programs.
 
Personnel + facilities

The NCCCR is located on the seventh floor of the South Building within the ambulatory Cancer Center. It is centrally located within the cancer center's Clinical Care Facility, adjacent to the Division of Hematology/Oncology, the Breast Health Center, and the Breast Imaging Center.

The Facility includes 10 offices and a centralized audit area/conference region with shared computer resources and access to all hospital information systems. Storage for active protocol files resides within the center. The NCCCR has immediately adjacent conference capacity for meetings of up to 30 individuals. Telemedicine capability exists for joint protocol discussions with affiliates where desirable.

The NCCCR personnel include Clinical Research Coordinators (CRCs), Clinical Research Nurses, and Regulatory and Start-Up teams.

The NCCCR affects compliance with regulatory agencies.

The NCCCR communicates with sponsors and facilitates their oversight of trials.

The NCCCR provides continuing education, credentialing, seminars, and support for all research staff, and monitors institutional credentialing for participants.

The Neely Center plays an essential role for the Tufts Medical Center Cancer Center in providing regional access to trials by providing oversight and technical support for trials that can be conducted through the affiliate network.

The NCCCR has a laboratory dedicated to processing research specimens.
 
Principal investigators + research team leadership

Clinical Leaders of individual disease programs work within multidisciplinary teams to select protocols based on priority for completion within the disease program and coordination by the center.

Protocols deemed high priority are placed on the fast track for opening either through Tufts Medical Center IRB or through the central IRB processes in place at Tufts Medical Center, with the permission of the local IRB.

The NCCCR structure enables coordinators to work directly with principal investigators on task assignments while reporting directly to administrative support for credentialing, education, procedural matters, and personnel reviews. The NCCCR has established ongoing mechanisms to support staff training, education, and expertise. 

The NCCCR Director reports to the Tufts Medical Center Research Administration.  The Director works directly with Cancer Center leadership to oversee the implementation of identified strategic initiatives for clinical cancer research at Tufts Medical Center and across Tufts Medicine.  The Director oversees all NCCCR personnel for the execution of cancer clinical trials, including investigator-initiated, cooperative group, and industry-sponsored trials.  The Director reports performance on cancer clinical trials to Cancer Center leadership and reporting committees for Cancer Center accreditations.