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Case Study: FIREBIRD
Clients
National Cancer Institute Center for Biomedical Informatics and Information Technology (NCI CBIIT), National Cancer Institute Division of Cancer Prevention (NCI DCP), National Cancer Institute Cancer Therapy Evaluation Program (NCI CTEP), Federal Drug Administration (FDA), FDA/NCI Interagency Oncology Task Force (IOTF), pharmaceutical participants including Pfizer, Abbot, Amgen, Astra Zeneca, Genzyme, Johnson & Johnson, Lilly, Merck, Novartis, Roche, and Sanofi Aventis
Industry
Clinical ResearchOverview
Brought together by a common desire to manage clinical investigator information securely and electronically, the NCI, FDA, and industry entities united to facilitate the exchange of clinical research information between NCI and FDA. The result was the Federal Investigator Registry of Biomedical Information Research Data (FIREBIRD) of the FDA and NCI’s Interagency Oncology Task Force (IOTF). Envisioned as a web application to facilitate communication between clinical trial sponsors, investigators, and the FDA, while employing a digital signature technology to make a formerly paper-based process completely electronic, FIREBIRD was intended to function as the global investigator registry for commonly referenced data and a secure storage of regulatory submission information that could be easily queried. FIREBIRD would enable investigators to register online with NCI and other sponsors, including pharmaceutical companies, and allow investigators, sponsors, and the FDA to centrally maintain and manage all FDA Form-1572 registrations.
Problem
Managing complex requirements from a variety of stakeholders with conflicting requirements is difficult to manage, from both a requirements and architectural standpoint. Attempting to create a new system through the organic growth of existing NCI software applications resulted in disparate interfaces and a duplicative code base. The NCI requested that 5AM join the project to resolve bugs, add features, and deploy the software so that the pilot stakeholders could use it to see how the software would meet their requirements and where it needed to be improved.
Solution
5AM engaged with stakeholders and program managers to understand the obstacles to releasing FIREBIRD as a pilot, and quickly fixed bugs and enabled new features to put the software into use within a matter of weeks. Our engineers and analysts worked with the FIREBIRD group to support the software through its pilot phase, during which extensive testing uncovered additional defects as well as new needs and features. We were able to leverage the pioneering efforts of many to produce iterative and incremental improvements, and we consistently and transparently shared our findings and results - whether positive or negative - with the community of stakeholders. Following the pilot period, NCI requested that 5AM work with its internal stakeholders to strengthen the software for production release and to appropriately scope and add new features, quickly. Mindful of HIPAA guidelines, NIH policies, and the business processes of the respective organizations, we engineered the FIREBIRD application to support these processes, indicate opportunities for process improvement through either business process re-engineering and/or corresponding software changes, and SOP’s and software for supporting data quality and curation.
Benefits
NCI had invested time and energy into software that needed to be piloted by its interested and involved stakeholders. Our software engineering expertise allowed 5AM to quickly resolve the software-specific issues that enabled the stakeholder team to see their vision realized. This first step allowed them to envision how an electronic registry of investigation information could serve many uses, both within institutions and between institutions. Now in production and being used by DCP, FIREBIRD represents the IOTF’s vision in action, providing a completely electronic registry of investigator regulatory information. Our team has been engaged to begin work on the next version of FIREBIRD, with expanded features to meet the additional requirements of the original larger group of stakeholders, including the FDA, to complete the realization of the interagency vision.