Why Real World Evidence (RWE) Studies Need Implementation Research: The Value Proposition

Background: Real World Evidence (RWE) studies seek to characterize the effectiveness and safety of new treatment regimens in real world contexts. It has been repeatedly shown, however, that data on effectiveness and safety alone are not sufficient to support successful uptake of new therapies and innovations into healthcare delivery, nor their continued safe and appropriate use over time. As healthcare costs continue to escalate, efficient and effective ways to promote the uptake and adoption of new, evidence-based approaches into healthcare delivery are increasingly vital.
Implementation science research (ISR), which focusses on the use of strategies to adopt and integrate evidence-based health interventions into specific settings to improve health outcomes, can address such challenges. Despite growing recognition of its importance by regulators and industry, ISR terminology, methods and study designs may be unfamiliar to many pharmacoepidemiologists. Similarly, there is a need for examples of successful collaborations between pharmacoepidemiologists and implementation researchers on RWE-ISR studies resulting in health policy impact.

Objectives: 1. To introduce pharmacoepidemiologists to Implementation Science Research (ISR), including key concepts, terminology and methods.
2. To educate pharmacoepidemiologists about approaches for incorporating implementation research questions and methods into RWE studies.
3. To present a regulator’s perspective on the value of RWE-ISR studies for regulatory decision-making.
4. To illustrate the value proposition for integrating implementation research in RWE studies using a case example from second-generation antipsychotics and cardiometabolic risk.

Description: This session proposes to address this gap and to provide pragmatic guidance for collaboration and synergies between the two fields of RWE/pharmacoepidemiology and implementation science moving forward:
1. An Introduction to Implementation Science Research (ISR): Key Concepts, Methods and Terminology. Session Chair: Meredith Smith, PhD, MPA, FISPE
2. “Why and How”: Incorporating Implementation Research Questions into RWE studies: Standards and Approaches for Study Design and Conduct. Mehmet Burcu, PhD, Merck
3. The Value of RWE and IR research together: A Regulator’s Perspective. Gita Toyserkani, US FDA.
4. The Case of Second-Generation Antipsychotics and Cardiometabolic Risk in the US: A case study of Successful Collaboration between Pharmacoepidemiologists and Implementation Researchers on RWE-ISR studies. Elaine Morrato, DrPH, MPH, FISPE, Loyola University Chicago.
5. Facilitated Panel Discussion and Q&A with Audience