During the June 7, 2012, FDA public workshop, “Risk Evaluation and Mitigation Strategy (REMS) Assessments: Social Science Methodologies to Assess Goals Related to Knowledge,” ASCO REMS Working Group Chair James Frame, MD, FACP, stressed various REMS challenges that can detract from patient care because of administrative burden and system redundancy. In addition, he presented strategies for REMS assessment and opportunities for improvement, including:

• Practice-level chart review, which would provide a benchmarking opportunity to identify quality gaps and best practices
• Real-time data mining by means of rapid learning systems, including ASCO’s CancerLinQ™
• Post-marketing safety studies
• Timing studies Input from this workshop will be used to develop best practices of conducting an assessment of a REMS goal regarding patient and/or health care provider knowledge about a drug’s risk(s).

In the coming months, more robust comments will be submitted by ASCO to the docket (FDA–2012–N–0408).