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Case Study: Clinical Trials Reporting Program (CTRP)
The NCI CTRP seeks to expedite the delivery of important new cancer therapies to patients through enhanced information sharing. CTRP includes a comprehensive repository of up-to-date information on NCI-funded clinical trials and a suite of applications.
The Client + The Challenge
The NCI sought to transform their clinical trials enterprise by addressing several dimensions of coordination, the first of which is the initiative to enhance information sharing among sites. For over 50 years, the NCI has supported a standing infrastructure — the Clinical Trials Cooperative Group Program — to conduct large-scale cancer clinical trials across the nation, with successful completion of many important trials that have led to new treatments for cancer patients. But a recent report revealed gaps in coordination and sharing among sites that hampered the ability of the program to initiate and conduct state-of-the-art trials for cancer patients. In response to the report, the NCI established the Clinical Trials Reporting Program (CTRP) to establish a comprehensive repository of up-to-date information on all NCI-funded clinical trials, and enable the seamless transfer of clinical trial data to advance cancer research.
The Result
5AM Solutions was one of several companies initially asked to build the CTRP repository and suite of applications to facilitate the reporting, analysis, and sharing of clinical trial data across sites. In 2010, 5AM was chosen to take over all of the architecture, design and development work for CTRP. Using the Glassbox® Software Development Process, 5AM coordinated with stakeholders to refine requirements and deliver the technical solution in an iterative manner, staying flexible and reprioritizing features as the NCI refined the focus of their program. The CTRP suite encompasses web-based applications and web services that support registration of clinical trials by investigators, detailed abstraction of protocol information by curators, and submission of patient accrual data.
- The CTRP Registration site enables investigators to submit new clinical trial protocol details, and to search for clinical trials submitted by members of the cancer research community. The CTRP Registration application manages information about all aspects of the trial including lead organization, sites, investigators, sponsor, phase, status, FDA IND/IDE information, grant information, and regulatory information. CTRP also allows other systems like Velos and Forte to programmatically submit trial information to CTRP in an industry standards-based manner, leveraging the BRIDG Domain Analysis Model and ISO 21090 Healthcare Data Types.
- The CTRP Protocol Abstraction application allows the curators in the NCI’s Clinical Trials Reporting Office to abstract more structured information from the protocol documents submitted by the investigators. This abstracted data includes administrative data such as participating sites, as well as scientific data such as eligibility criteria, trial arms, drugs and biomarkers.
- The CTRP Accrual application enables submission of patient or participant information for a trial registered in CTRP, including support for batch uploads in the Clinical Data Update System (CDUS) format. The eventual goal of CTRP Accrual is to collect data from various sources including CDS Web, CDUS Smart Loader, Theradex CTMS and CTSU OPEN.
- The CTRP Viewer application enables the NCI and cancer center leadership to run reports on trial status and patient accrual.
5AM is bringing the NCI closer to achieving the mission of caBIG® as a truly collaborative information network – one that accelerates the discovery of new approaches to detect, diagnose, treat and prevent cancer, and, ultimately, improve patient outcomes.
Connect with 5AM
Innovative solutions are essential to improving clinical trials and research in general. Contact 5AM at info@5amsolutions.com or (866) 526-6042 to discuss opportunities for engagement on your most critical projects.