%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