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discussion leaders no more than 4 please include name(s), degree(s), position(s), institution( s), city, state and country


workshop
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workshop
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DEVELOPMENT AND VALIDATION OF CONCEPTUAL MODELS, CONCEPTUAL FRAMEWORKS AND ENDPOINT MODELS FOR PRO RESEARCH

DISCUSSION LEADERS: Diane Wild MSc, Director, Oxford Outcomes Ltd, Oxford, UK; Christina Donatti LLB, MSc, PsyD, PhD-student, General Practitioner, University of Southern
Denmark, Research Unit of General Practice, Odense, Denmark; Palle Mark Christensen PhD, Senior Outcomes Researcher, Oxford Outcomes Ltd, Oxford, UK;
Asha Hareendran PhD, Manager, Outcomes Research, Pfizer Ltd, Sandwich, UK; Annabel Nixon PhD, Senior Outcomes Researcher, Oxford Outcomes Ltd, Oxford, UK


Workshop Purpose:
The purpose of this workshop it to understand and clarify the role of conceptual models, conceptual frameworks and endpoint models in light of the recent
draft FDA guidance document.


Workshop Description:
Conceptual models, conceptual frameworks and endpoint models are essential research tools used by patient reported outcome (PRO) researchers.
However, there is considerable lack of agreement regarding their definition, development and validation approach, and utilisation. The purpose of this workshop is to understand
and clarify the role of each tool, in light of the recent draft FDA guidance document. Discussions will examine the perspective of the FDA as well as the clinical research perspective
and implications for the development and validation of PRO tools to support product label claims. Specifically, the following issues will be addressed for conceptual models,
conceptual frameworks and endpoint models: • Clarification and description of purpose • Establish the current FDA/EMEA position • Quantitative and qualitative methodologies for
development and validation • Timing issues in the context of clinical research programs • Utilisation of each as complementary research tools. Examples will be drawn from the
presenters' own research experiences as well as from the published literature. The implications for clinical and clinical trial research will be discussed. Audience participation will
be encouraged through active discussion and the workshop will also include an interactive team-based exercise focused on clarifying the role and design of conceptual models,
conceptual frameworks and endpoint models. This workshop will be of interest to PRO/health-related quality of life (HRQL) researchers and those involved in clinical research
including drug development.

Sumbit Abstract Proposal or Case Study


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