Enabling social listening for cardiac safety monitoring: Proceedings from a drug information association-cardiac safety research consortium cosponsored think tank.

This white paper provides a summary of the presentations and discussions from a think tank on "Enabling Social Listening for Cardiac Safety Monitoring" trials that was cosponsored by the Drug Information Association and the Cardiac Safety Research Consortium, and held at the White Oak headquarters of the US Food and Drug Administration on June 3, 2016. The meeting's goals were to explore current methods of collecting and evaluating social listening data and to consider their applicability to cardiac safety surveillance. Social listening is defined as the act of monitoring public postings on the Internet. It has several theoretical advantages for drug and device safety. First, these include the ability to detect adverse events that are "missed" by traditional sources and the ability to detect adverse events sooner than would be allowed by traditional sources, both by affording near-real-time access to data from culturally and geographically diverse sources. Social listening can also potentially introduce a novel patient voice into the conversation about drug safety, which could uniquely augment understanding of real-world medication use obtained from more traditional methodologies. Finally, it can allow for access to information about drug misuse and diversion. To date, the latter 2 of these have been realized. Although regulators from the Food and Drug Administration and the United Kingdom's Medicines and Healthcare Products Regulatory Agency participated in the think tank along with representatives from industry, academia, and patient groups, this article should not be construed to constitute regulatory guidance.

Ground Reaction Forces in Children's Gait.

Ground reaction force patterns during walking were observed in 18 children 3 and 4 years of age. The children walked barefoot at a self-chosen walking pace. Selected variables representing the vertical, anteroposterior, and mediolateral force components were evaluated. The results indicated that children in this age range contact the ground with greater vertical force measures relative to body mass than do adults. In addition, the minimum vertical force was lower, the transition from braking to propulsion occurred earlier, and the mediolateral force excursions were higher than typically found in adults. When the children were divided into groups on the basis of sex, differences were observed between those groups. The boys exhibited a greater difference in the vertical peak forces, a lower minimum force, a greater braking force, and a higher mediolateral force excursion value. The results indicated that children display a different ground reaction force pattern than do adults and that differences between boys and girls may be observed as early as ages 3 and 4 years.