What can improve physician and patient access to NCI-sponsored clinical trials?

Challenge

The rapid increase in new therapies and technologies in a shifting health care and fiscal environment spurred the National Cancer Institute (NCI) to launch the Cancer Trials Support Unit (CTSU) in 1999 to streamline and harmonize support services for multicenter, large-scale, phase 3 cancer clinical trials across the country.

Specifically, the initial launch of the CTSU centralized collection of site regulatory and roster data provided a central website for sites to access protocols and protocol documents and facilitated cross-group enrollments. This led to an increase in efficiency and greater access of qualified investigators and clinical sites to NCI-funded clinical trials, thereby increasing patient access to clinical trials close to their homes.

These activities would require a team player with both operational and IT development proficiency, systems security expertise, a commitment to quality assurance, a talent for creative solutions, plus the flexibility to change direction to meet new needs. NCI contracted with Westat in 1999 to help run the CTSU. We have retained this work ever since.

Solution

Since 1999, the CTSU has continued to provide innovative solutions. Critical to clinical trial success is the enrollment of patients, and with Westat’s development and maintenance of the Oncology Patient Enrollment Network (OPEN) system, clinical sites in the U.S. and internationally can enroll patients in clinical trials 24 hours a day. OPEN integrates with protocol, roster, and regulatory data to ensure qualified sites enroll to studies and integrates with outside systems to support data collection and reporting. Our software engineering services drive the development, implementation, and project integration for multiple collaborative systems. Our CTSU IT system incorporates industry-standard best practices, process improvements, and closure of capability gaps by achieving appraisals for ISACA’s Capability Maturity Model Integration (CMMI) for Development (DEV) at Level 3.

Data Harmonization

Westat synchronizes the implementation of a common clinical data management system (CDMS), Medidata Rave, across NCI’s Cancer Therapy Evaluation Program (CTEP) system. Through data harmonization, we integrate heterogeneous databases across sites so that data from participants in cancer clinical trials can be harmonized and pooled. These data are then available for analyses based on a common standard.

Tools

To streamline and automate clinical trial data processing, enhance quality, and support regulatory submission, we employ CDISC standards (CDASH, STDM, and ADaM). In addition, Westat uses interactive data visualization techniques to monitor site performance against key performance indicators, document audit performance, and produce camera-ready graphics for publication. These techniques improve not only trial efficiency but also participant safety.

Supporting Infrastructure

To support CTSU activities, an enterprise Oracle database has been developed and integrated with the client’s enterprise Oracle database—providing back-end support for the project website and applications. This infrastructure has been extended to provide real-time information exchange with other research organizations through advanced XML messaging technologies and web services. The comprehensive CTSU website includes a listing of active CTSU-supported clinical trial protocols, displays of accrual information, and links to study abstracts facilitating investigator and research staff participation. CTSU’s suite of applications runs on different platforms and is hosted at Westat’s data center. Business continuity is ensured by having multiple levels of redundancy.

Clinical Site Support Tasks

Other supportive activities include providing robust educational resources on the CTSU website; helping sites organize study activities, including creating National Coverage Analysis (NCA) templates and Electronic Medical Record (EMR) setup templates; operating a helpdesk for clinical trial researchers and staff support; and developing and maintaining a comprehensive clinical trials systems infrastructure, which provides real-time data exchange with collaborating organizations. We support clinical site performance management by collecting data quality metrics through the Westat-developed Data Quality Portal (DQP) and Performance Assessment Site Score (PASS) applications, and also support remote-based monitoring and site auditing by providing a Westat-developed Source Document Portal (SDP) for uploading source documentation.

Additionally, we extend services to NCI-sponsored clinical trials such as the National Clinical Trials Network (NCTN), the Experimental Therapeutics Clinical Trials Network (ETCTN), and the Community Oncology Research Program (NCORP), as well as other programs.

Results

Our operation of CTSU has made clinical trials available to a wider audience of investigators and provided the infrastructure for 500+ trials and the enrollment of 500,000+ patients since its inception in 1999. The clinical trials we have supported have led to the development of lifesaving treatments, new diagnostic tools, and better medical devices benefiting millions of cancer patients in the U.S. and worldwide.

Examples of data emanating from CTSU include the Trial Assigning Individualized Options for Treatment (Rx) or TAILORx trial, which showed no benefit from chemotherapy for 70% of women with the most common type of breast cancer and resulted in better or more effective treatment plans for these patients. Also, operating groundbreaking precision medicine trials, such as MATCH, the Exceptional Responders trial, and LUNG-MAP, have deepened researchers’ understanding of cancer treatments.

CTSU is an integral component of NCI’s support of the Biden Administration’s Cancer Moonshot initiative. Westat will be coordinating the implementation of clinical trial protocols and providing regulatory support services, providing 24/7 operational support to the entire lifecycle of these clinical trials.