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.

Program

27  January 2017

Time	Event	Chair
09:00 - 09:10	Welcome: Barbara Osimani
09:10 - 09:30	Rani Lill Anjum and Elena Rocca (Norwegian University of Life Sciences): Post Market Risk Assessment of Drugs as a Way to Uncover Causal Mechanisms	Jürgen Landes (Munich)
09:30 - 09:50	Jon Williamson (University of Kent): EBM+: Improving the Way in Which Evidence-Based Medicine Handles Evidence of Mechanisms
09:50 - 10:10	Felipe Romero and Jan Sprenger (University of Tilburg): Making Scientific Inferences More Objective: Replication and Scientific Self-Correction
10:10 - 10:30	Barbara Osimani (MCMP/LMU Munich): A Multilayer Approach to Modeling Probabilistic Causal Inference through Evidence Synthesis
10:30 - 10:50	Q & A
10:50 - 11:15	Coffee Break
11:15 - 11:35	Jeff Aronson (Oxford University): Defining a Signal	Barbara Osimani (Munich)
11:35 - 11:55	Ralph Edwards (WHO, Uppsala Monitoring Center): Causality in Pharmacovigilance: Small Chances – Big Problems
11:55 - 12:10	Q & A
12:10 - 13:15	Lunch
13:15 - 13:35	Mike Kelly (The National Institute for Health and Care Excellence/Cambridge University): EBM, Reductionism, and the Road to Medicine’s Adaptive Pathways	Bennett Holman (Seoul)
13:35 - 13:55	Ulrich Mannsmann (IBE/LMU Munich): How to Quantify the Effect of and Correct Design-dependent Bias in RCTs
13:55 - 14:10	Q & A
14:10 - 14:35	Coffee Break
14:35 - 14:55	Brigitte Keller-Stanislawski (Paul Ehrlich Institut): Benefit Risk Evaluation of Medicinal Products Post-Authorisation and Evidence Based Decision Making in Pharmacovigilance	David Teira (Madrid)
14:55 - 15:15	Beth Shaw (NICE): Assessing Drug Safety – What Can We Learn From Other Assessments of Harm
15:15 - 15:35	Q & A
15:35 - 16:00	Coffee Break
16:00 - 16:20	Stephen Senn (CCMS, Luxembourg Institute of Health): What Randomisation Can and Cannot Do for You	Roland Poellinger (Munich)
16:20 - 16:40	Norbert Benda (BfArM): Challenges for a Decision-Theoretic Framework in Drug Safety and Benefit Risk Assessments
16:40 - 17:00	Q & A
17:00 - 17:30	General Discussion	Barbara Osimani, Jürgen Landes, Roland Poellinger (Munich)
20:00	Conference Dinner

28 January 2017

Time	Event	Chair
09:30 - 09:50	Stephen Mumford (University of Nottingham): Evidence Synthesis for Dispositionalists	Rani Lill Anjum (Oslo)
09:50 - 10:10	Adam La Caze (University of Queensland): Evaluating Evidence in Drug Safety
10:10 - 10:30	Jacob Stegenga (Cambridge University): Bayesian Mechanista
10:30 - 10:50	Q & A
10:50 - 11:15	Coffee Break
11:15 - 11:35	Roland Poellinger (MCMP/LMU Munich): Shaping Causal Claims in Pharmacology: The Interplay between Population Characteristics and Causal Structure	Adam La Caze (Queensland)
11:35 - 11:55	Jürgen Landes (MCMP/LMU Munich): Variety of Evidence
11:55 - 12:15	Martin Posch and Franz König (Center for Medical Statistics, Informatics and Intelligent Systems, Medical University of Vienna): Challenges of Optimizing Drug Development Programs for Regulatory Decision Making
12:15 - 12:35	Q & A
12:35 - 13:40	Coffee Break
13:40 - 14:00	David Teira (UNED Madrid): Evidential Pluralism and Regulatory Paternalism in Drug Testing	Sara Ruggieri (AIFA)
14:00 - 14:20	Bennett Holman (Yonsei University) and Justin Bruner (Australian National University): Experimentation by Industrial Selection
14:20 - 14:35	Q & A
14:35 - 14:50	Coffee Break
14:50 - 17:00	Round Table	Carlo Martini (Helsinki), Christina Schneider (Munich)

 Acknowledgement

The conference is generously supported by the European Research Council (Grant 639276). Further information on the project can be found here.