%0 Conference Paper %A Greenway, Ian %A Sande, Maria Vander %D 2018 %T EVIDENCE GENERATION: IDENTIFYING AND ADDRESSING GAPS TO MEET THE CLINICAL AND EDUCATIONAL NEEDS OF STAKEHOLDERS %U https://medicalaffairs.figshare.com/articles/poster/EVIDENCE_GENERATION_IDENTIFYING_AND_ADDRESSING_GAPS_TO_MEET_THE_CLINICAL_AND_EDUCATIONAL_NEEDS_OF_STAKEHOLDERS/5919316 %R 10.6084/m9.figshare.5919316.v1 %2 https://medicalaffairs.figshare.com/ndownloader/files/10573000 %K clinical development %K health-care %K Medicine %X Objectives: To provide a clear framework that enables a thorough situational and behavioral analysis to be conducted to identify evidence gaps in the clinical development plan that may become a barrier to effective product use by health-care professionals. To understand the range of options available to address these key evidence gaps, and how to effectively and efficiently implement a compelling evidence-generation plan early in a product’s development that will support all key stakeholders’ educational needs throughout its life cycle.

Challenge/problem: Situation analyses and their subsequent interpretation are often conducted in an inconsistent manner and do not always take into account deep insights into the behavioral and cultural environment of health-care professionals and their patients. This can leave vital gaps in a product’s evidence base. Coupled with this, evidence-generation planning is often highly reactive. As a result, medical plans are not always grounded in the right evidence to address key stakeholder needs through the life cycle and may lack a consistent thread from medical strategy through to communication tactics.

Solution: To develop a framework for comprehensive and robust evidence platform generation, with its translation into actions that drive positive behavioral change in health care through engaging and creative multichannel delivery.

Outcome: A medical plan that ensures valuable evidence is anticipated, in place, and linked to a clear end goal of positive behavioral change in patient care. Benefits: Starting a formal evidence-generation and communication process early in development (i.e. Phase 2) ensures that the necessary information is available to make pricing, reimbursement, and product-positioning decisions at the time of launch.
%I Medical Affairs Professional Society