Recommendations to Enable Broader Use of Real-World Evidence to Inform Decision-Making Throughout Pharmacovigilance Signal Management.

INTRODUCTION: Despite substantial investments in analytical infrastructure and scientific research related to the development and analysis of real-world evidence in support of signal management, the impact on routine pharmacovigilance activities has been limited. Most organizations still rely largely on analyses of individual case reports and pre-existing evidence - especially during signal detection and validation. OBJECTIVE: This paper presents a set of recommendations for efforts to enable broader use of real-world evidence throughout pharmacovigilance signal management, in the future. OUTCOME: The recommendations regard streamlined data access, data harmonization and use of reproducible analytical workflows to enable rapid and robust evidence generation. They emphasize the need for cross-disciplinary collaboration and for organizational adaptations to ensure adequate competence and supporting processes, including principles for how to integrate new types of evidence in decision-making. The execution of pilot studies under realistic conditions and the dissemination of their findings are highlighted as important steps toward defining the proposed change and driving progress in this area. This manuscript is endorsed by the International Society for Pharmacoepidemiology (ISPE).