Regulatory Science: Addressing Uncertainties in Medicines Development, Evaluation and Use

A peer-reviewed publication by the Pistoia Alliance Social Media Listening and Real-World Evidence project has been recognized in a compilation of highly relevant voices on regulatory science and strategies to address uncertainties in medicines development, evaluation and use.

The synopsis of the e-book published by Frontiers in Medicine explains the inclusion of the article as:

“Additional contributions on this topic address patient-focused drug development through the analysis of patient perspectives shared on social media (Cimiano, et al). Authors explore how social media listening (SML) methods are increasingly applied and how evidence derived from social media can be used in the drug development process, for identification of unmet patient needs and its impact on regulatory decision making. The perspectives of patients, developers and regulators on the role of SML in drug development were reviewed, together with a review of current SML practices and use cases. Findings suggest that stakeholders are strongly aligned regarding the potential of SML for patient- focused drug development, while also identifying areas where regulatory guidance is needed to reduce uncertainty regarding the impact of SML as a source of PED. Also, in an EMA HMA expert review report the potential of social media data for regulatory use was investigated through an analysis of scientific literature. This work resulted in a set of regulatory use cases, identification of challenges and opportunities, and key points for consideration to guide future actions for establishing the value and enabling the use of social media in medicine regulation.”