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Last Updated: 03/21/22

Clinical Trials Operations and Informatics Branch (CTOIB)

CTEP's Clinical Trials Operations and Informatics Branch (CTOIB) improves protocol development and conduct through system-supported efficient business practices, informatics tools, central review of clinical trials for human safety and subject protection, and process evaluation.

The Branch includes the Protocol and Information Office (PIO), the CTEP Enterprise System (CTEP-ESYS), the NCI Central Institutional Review Board (CIRB), the Cancer Trials Support Unit (CTSU) and other ancillary clinical trial support services.

PIO supports CTEP by collecting, processing, tracking, and monitoring all protocol-related information between CTEP and its extramural collaborators as well as with other CTEP and NCI programs.

The purpose of PIO is to:

  • Facilitate the development and conduct of quality clinical trials in the most efficient and expeditious manner possible
  • Minimize the administrative burden related to clinical trial development, conduct, and management on CTEP staff and the extramural community
  • Abstract protocol-related keywords and milestones into CTEP-ESYS to assist with CTEP decision making
  • Promote, inform, and educate all concerned parties regarding NCI programs, policies, and objectives related to clinical trial development, conduct, and management

CTEP-ESYS is a 20+ application system that allows CTEP, other NCI staff, and the extramural community to enter/review/request pertinent protocol-related information for the development, conduct, and review of clinical trials. This includes reporting information to the FDA, managing agent inventory and orders, registering investigators, supporting audit activities, reporting accrual data, entering adverse event information, and managing disease and agent portfolios.

The primary objectives of the CTEP-ESYS are to:

  • Capture data and translate it into a usable and streamlined format to address scientific, safety, regulatory, and administrative requirements of clinical trials
  • Eliminate data redundancy throughout the oncology community through integrated data systems
  • Improve communication between CTEP and its collaborators
  • Assure the security and confidentiality of proprietary and patient information
  • Support broad patient access to clinical trials
  • Expedite the protocol development and review process within both clinical trial organizations and reviewing bodies

The CTSU, another component of the Branch, works in tandem with CTEP-ESYS. CTSU simplifies admittance to NCI-funded clinical trials for qualified clinical sites and supports the conduct of those clinical trials. CTSU membership provides access to a wide range of assistance, including patient enrollment and data-collection services, for eligible investigators. The CTSU website also offers a listing of active CTSU-supported clinical trial protocols, displays accrual information, and provides links to study abstracts.

The primary objectives of the CTSU are to:

  • Facilitate investigator and research staff participation in selected NCI multi-center programs and their clinical trials
  • Increase investigator and patient awareness and enrollment to cancer clinical trials
  • Provide standardized, integrated, and comprehensive support services to selected NCI multi-center programs
  • Identify best practices and streamline or eliminate redundant processes and procedures
  • Improve operational efficiency, enhance productivity and deliver products offering measurable business value to selected NCI multi-center programs

The NCI CIRB helps reduce the administrative burden on local IRBs and investigators while continuing a high level of protection for human research participants. CIRB, with one centralized review, enables investigators to enroll patients into Network trials significantly faster than when employing the traditional method of assessment, which requires trial investigators in each site to obtain approval from a local IRB.

CTOIB also supports some process evaluation and data-analysis efforts for the NCI clinical trial Network systems. This includes using surveys and marketing analyses for the development and application of systematic accrual practices to aid challenging trials and evaluation of NCI programs, including the CIRB.

Finally, CTOIB provides several ancillary clinical trial support services for selected trials including protocol writing support; study awareness and training; biospecimen tracking; and EHR build and insurance coverage analysis.

About the Branch Chief

Michael Montello, PharmD, MBA Michael Montello, PharmD, MBA, has been with CTEP for 25+ years. He has led or participated in dozens of major initiatives and projects during his career. More…