|Tyson Mew, president of Ofni Systems, and Russell Barbare, Clinical Operations Manager for Ofni Systems, attended the Society for Clinical Data Management (SCDM) Annual Conference in Los Angeles, CA on September 22-25. The SCDM (Society for Clinical Data Management) Annual Conference is the world’s largest education event for clinical data managers and related professionals, attracting over 600 attendees from across North America and around the world. Steven Wilson, the director at FDA/CDER/DBIII and at FDA/CDER/OB/DBIII, organized and led ten other speakers for the FDA’s presentation to the conference. The FDA representatives included five attending the meeting and six presenting by conference call, who between them represented the three largest FDA divisions dealing with clinical research: the Center for Biologics Evaluation and Research (CBER), the Center for Devices and Radiological Health (CDRH), and Center for Drug Evaluation and Research (CDER). While the diverse presenters had many messages, the Prescription Drug User Fee Act, version Five (PDUFA V) and its ramifications were the primary focus of discussion.
Director Wilson introduced the topic of PDUFA V and other presenters went into more detailed commentary. One FDA presenter talked about the increased communication allowed between the FDA and Sponsors in order to ensure timely drug development. A representative of CDRH noted that the law allowed for significant expansion of that branch of the FDA. Another presenter talked the initiative to interconnect federally administered databases with prescription drug information and allow the FDA access to them. Some of the databases mentioned were Medicare, Medicaid, and armed forces. Overall, it appeared that the FDA presenters were looking forward to working on the various measures prescribed in the new law.
Director Wilson also introduced the theme that the FDA was further increasing the trend of expanding engagement with industry and other stakeholders. In addition to the expanded cooperation initiatives mentioned in the talks about PDUFA V sections, one of the major partnership goals is the development and implementation of clinical data interchange standards that are widely used and accepted. The primary discussion was the expansion of implementation of Clinical Data Interchange Standards Consortium (CDISC) standards. Related topics such as integration of clinical datasets based on CDISC standards and datasets based on Health Level Seven International (HL7) standards were also discussed.
In summary, the FDA talk was an interesting sampling of thoughts and initiatives from multiple viewpoints that showed the agency is pursuing both many department-dependent initiatives and some strong agency-wide collaborative efforts with pharma and other stakeholders.