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Philosophy of Pharmacology: Safety, Statistical standards and Evidence Amalgamation

Objective

"The project intends addresses safety assessment in pharmacology with a view on philosophical work on causality and causal inference from statistical data ((Pearl 2000; Spirtes, Glymour, Scheines 2000, Woodward 2003, Cartwright, 2007b). This interest is motivated by the fact that current evidence standards emphasize internal validity of studies and hence randomization, disregarding alternative routes to causal assessment, such as the joint support of different sorts of evidence to a given hypothesis. This may be particularly detrimental in that, much of the evidence for harms comes from anecdotal reports, case series, or survey data, which standard guidelines of evidence evaluation regard as being of poorer quality with respect to controlled (randomized) experiments. Although the role of this ""lower level"" evidence is increasingly acknowledged to be a valid source of information for the risk profile of medications (Howick et al. 2009, Hauben and Aronson, 2007), current practices have difficulty in assigning it a precise epistemic status and integrating it with more standard methods of hypothesis testing. The philosophical debate has already addressed similar questions in relation to the assessment of treatment efficacy (Worral 2010, Papineau, 1993; Cartwright, 2007). However, none of these contributions expressly addresses the specific issues arising in causal assessment for harms.
The project intends to change the evidence standards for safety assessment by providing a unified framework for the amalgamation of diverse evidence in safety assessment. In particular, the project intends to: 1) present a foundational analysis on statistical/causal inference with a focus on safety assessment; 2) Build a unified epistemic framework within which different kinds of evidence can be combined and used for decision; 3) Provide the theoretical framework for the development of new standards of drug evaluation.
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Topic(s)

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Funding Scheme

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ERC-STG - Starting Grant

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Call for proposal

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(opens in new window) ERC-2014-STG

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Host institution

UNIVERSITA POLITECNICA DELLE MARCHE
Net EU contribution

Net EU financial contribution. The sum of money that the participant receives, deducted by the EU contribution to its linked third party. It considers the distribution of the EU financial contribution between direct beneficiaries of the project and other types of participants, like third-party participants.

€ 643 084,05
Address
PIAZZA ROMA 22
60121 Ancona
Italy

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Region
Centro (IT) Marche Ancona
Activity type
Higher or Secondary Education Establishments
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Total cost

The total costs incurred by this organisation to participate in the project, including direct and indirect costs. This amount is a subset of the overall project budget.

€ 643 084,05

Beneficiaries (3)

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