Drug Safety, Probabilistic Causal Assessment, and Evidence Synthesis (27-28 January 2017)
Idea and Motivation
The latest regulatory amendments concerning pharmacovigilance practice made by the European Parliament and the European Council (Directive 2010/84/EU; Regulation (EU) No 1235/2010) put a special emphasis on joint efforts to develop an integrative information-based approach to pharmaceutical risk assessment. The related guidelines encourage the amalgamation of information from different sources (e.g. spontaneous case reports, literature, data-mining, pharmacoepidemiological studies, post-marketing trials, drug utilization studies, non-clinical studies, late-breaking information). Yet, the methodological bases for implementing such a policy are shaky in that causal assessment of adverse drug reactions still relies mainly on the (statistical) methods developed to test drug efficacy.
Philosophers have developed a variety of tools to address methodological and epistemological issues that arise in causal assessment in medicine. This research program interacts with the work of health professionals, methodologists, statisticians and epidemiologists. Moreover, social epistemology and decision-theoretic tools are increasingly acknowledged as useful instruments to model research dynamics, knowledge flux and evaluate funding policies. Since medical research and clinical practice are pervaded by all sorts of conflicts of interest, there is room for implementing these approaches to understand the way medical knowledge works in our social world.
This workshop aims to provide a platform allowing scholars and decision makers to focus on causal assessment for the purposes of drug safety. In particular, the following topics, among others, will be explored and investigated: limits and potential of standard methods for evidence synthesis (meta-analysis, systematic review), mixed methods, machine learning and spontaneous reporting, safety pharmacology, systems pharmacology, evidence based medicine versus pluralistic approaches to evidence evaluation, and social epistemology in pharmacology.
In addition, the workshop is intended to foster novel approaches to risk management and decision making.