Sponsors of clinical trials conducted under an investigational new drug (IND) application are required to report serious and unexpected suspected adverse reactions in an IND safety report to the FDA and participating investigators within 7 or 15 days depending on the type of event (21 CFR §312.32). From 2015 to 2017, FDA's drug review divisions received an average of approximately 50,000 reports per year. The current process for submission and review of IND safety reports submitted to the FDA as PDF files or on paper is inefficient, labor intensive, and poses significant challenges for safety signal detection and tracking.
FDA's Information Exchange and Data Transformation (INFORMED) Program, in collaboration with the Office of Surveillance and Epidemiology (OSE), conducted a pilot that created a digital framework for the electronic submission of IND safety reports so that data in these reports can be visualized, analyzed, and tracked.
General workflow and technical configuration of the FDA INFORMED premarket safety reports pilot program
In April 2018, the FDA Commissioner Dr. Gottlieb announced the launch of a new Premarket Digital Safety Program for Agency-wide implementation of the piloted digital framework.
A survey conducted by INFORMED in 2016 showed that FDA reviewers spend an average on 16% of their time on premarket safety reviews, most of which is spent on paper and PDF file management. At full implementation of the Premarket Digital Safety Program, hundreds of full-time equivalent hours per month are expected to be saved (Figure from FDA public presentation at LunGevity Workshop, 2017)
In 2017, the American Society of Clinical Oncology (ASCO), published a recommendation supporting creation of a global safety data bank based on the digital safety framework development by INFORMED.
"A neutral third party, such as a nonprofit organization formed by an industry consortium or a public-private partnership, should create a globally available, central electronic portal that enables users to report and access adverse event data relevant to all trials in which they participate. This would provide investigators with context to inform clinical judgments regarding attribution of adverse events, as well as facilitate regulators, sponsors, and IRBs identification of important safety signals." REFERENCE
In response, INFORMED launched a global premarket safety initiative to design the technical and organizational building blocks of a global premarket safety data bank, which can transform safety signal detection and monitoring, significantly improving the ability to protect the safety of patients enrolled in clinical trials.
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