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EVIDENCE GENERATION: IDENTIFYING AND ADDRESSING GAPS TO MEET THE CLINICAL AND EDUCATIONAL NEEDS OF STAKEHOLDERS

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posted on 25.02.2018 by Ian Greenway, Maria Vander Sande
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.

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