Link to EAHP Statements

• Section 4 – Clinical Pharmacy: Statements – 4.3, 4.8
• Section 5 – Patient Safety and Quality Assurance: Statements – 5.2
• Section 6 – Education and Research: Statement Statements – 6.4

Abstract

There is an increasing interest in providing real world evidence for healthcare decision-making. Real-World Data may offer unique opportunities to understand the effectiveness, safety, and outcomes of interventions in real world patient populations. Real world evidence derives from analysing this data, which can be generated in randomised clinical trials, prospective or retrospective observational studies, or routinely collected data from clinical practice, electronic health records, health registries, and other sources. Real-World Data can be useful to investigate, for example, the size and characteristics of a specific patient group of interest even over longer time periods, to describe the current standard of care in a patient population, or to identify rare adverse events.

However, there are as well challenges and limitations of using Real-World Data for generating evidence. These challenges include data quality and completeness, selection bias, or possible confounding. Therefore, before relying on Real-World Data in clinical decision making, the suitability and the validity of the data need to be clarified, as well as the question of whether the used data sources really include the information required (both in quantity and quality).

This seminar will provide the basic knowledge on how to define necessary criteria for the use of real-world data for a specific research question. Besides, it will give insight into the adequate design of a research project with real world data, to finally create valuable real-world evidence.

Learning objectives

After the session, the participant should be able to:

• Outline basic and advanced principles of trial designs with real world data
• Evaluate the use of routinely collected data and assess its validity and its informative value
• Assess the potential benefits of using real world data and its challenges and limitations

Educational need addressed

Hospital pharmacists need to know details regarding the judicious use of real world data in order to set up their own research project to create real world evidence.

Keywords

Clinical trials, real world data, real world evidence, big data, study design, evidence-based medicine