NCI Virtual Clinical Trials Office (VCTO) Pilot Program

Background

DCTD has launched a pilot program to address the trend of decreased participation in NCI-sponsored clinical trials, exacerbated by the widespread resignation of research personnel that occurred during the COVID-19 pandemic.

The loss of trained clinical research professionals is:

compounding the already complex nature of clinical trial operations and management
aggravating the existing barriers to clinical trial access and participation
especially detrimental to the availability of opportunities for clinical trial participation for minority and underserved populations

The VCTO pilot program aims to validate the feasibility of remote, centralized support to further identify and address barriers at local oncology practices and clinical research sites, thereby enhancing patient accrual and retention rates to NCI-sponsored clinical trials.

Mission

Improve accrual and retention rates to NCI-sponsored clinical trials-especially among minority and underserved communities-by building active partnerships with clinical sites across the U.S. to address staffing challenges and reduce the burdens of clinical research.

Implementation

The VCTO pilot program will provide a dedicated team of remote research staff to support a site's clinical research efforts by:

screening and enrolling patients
providing clinical trial education to patients and participants
assisting with data capture and query resolution

As a pilot program with a variety of sites to support, the VCTO team will adapt to the range of clinical trial and organizational needs. This agility will enable the team to compare clinical trial support interventions across sites, identify dynamic pathways for pilot success, and establish best practices for virtual support.

The Frederick National Laboratory for Cancer Research, which is operated by Leidos Biomedical Research, Inc. for NCI, is managing and coordinating the VCTO pilot program. NCI selected six U.S. sites with varying geographical settings and clinical practice characteristics for initial pilot participation. The sites include a mixture of NCI-designated cancer centers and NCI Community Oncology Research Program consortia members.

Funding supports the VCTO program through September 2027. NCI may request increased capacity options/program expansion based on the evaluation of VCTO support to clinical sites and trial portfolios, and the impact of VCTO engagement on accrual rates and data management.

NCI is optimistic that all clinical practices, regardless of their scope, patient population, or location, will benefit from the lessons learned during this pilot.