After a successful pilot program, the US Food and Drug Administration (FDA) is fine-tuning a transition to all-digital submission of safety data from clinical trials of investigational drugs.
The goal is to modernize the submission of regulatory data by shifting from use of multiple PDF documents into a digital submission format with structured data elements “that will allow us both to improve the data quality and also allow us to use new analytic tools,” to make other novel uses of submission data, said Meredith Chuk, MD, Acting Associate Director for Safety with FDA’s Office of Oncologic Diseases.
Speaking of the submission of certain required reports of serious safety events occurring in clinical trials of investigational drugs, Chuk said, “The current method for submission of these reports is actually as PDF forms, and it’s extremely inefficient,” since FDA may receive as many as 50,000 safety report forms per year. Chuk spoke Tuesday at a day-long meeting focused on modernizing FDA’s data strategy. “Review and tracking of these important safety data by medical reviewers is challenging.”
A digital submission and review process could overcome many of the challenges of the current way of doing business, said Chuk, noting that international data standards should be used “to be able to connect the dots in a way that we haven’t been able to previously.” In drafting the digital submission process, international standards were adapted to comply with US regulatory requirements, she clarified.
The current process involves having a sponsor “unstructuring” data that is already structured in its own safety database in order to fill out the PDF report, pointed out Chuk. Each form is transmitted electronically to FDA and housed in individual folders within the agency’s data structure. “So the hundreds of medical reviewers at FDA – physicians, pharmacists, nurses – have to individually look at all of these PDF forms and make the connections on their own tracking systems,” using sticky notes or physical piles of paper to keep things sorted out, she said.
The PDF system currently in use is time-consuming and inefficient, added Chuk; most importantly, she said, safety signal detection and tracking is hindered.
In the new submission process, sponsored will use their structured safety data to generate an XML file that is sent through the existing FDA gateway directly into the FDA Adverse Events Safety Reporting System (FAERS). That system, explained Chuk, will hold both Investigational New Drug (IND) and post-marketing safety reports.
Having these safety data available in a unified, structured format will allow reviewers to use advanced analytic tools “across the development program and across the life cycle of the drug,” she said. The submission pathways will remain separate, and IND safety reports will not be included in the publicly viewable post-market safety database.
In its entirety, the new process will help sponsors meet their 7- or 15-day adverse events reporting requirements and be scalable for FDA, as well as making better use of the data for insights into safety, said Chuk.
Amid internal and external change management, draft guidances on the transition to digital submissions are being pulled together by FDA. The shift to digital transmissions will begin two years after the finalization of the draft guidances.
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