Using Data to Design and Execute Studies to Support End-to-End Real-World Evidence Needs

According to the International Society for Pharmacoeconomics and Outcomes Research (ISPOR), real-world evidence (RWE) is the #1 trend in HEOR for 2020 and is playing an increasing role in health care decisions globally. Regulatory bodies such as the FDA and EMA have traditionally used RWE to monitor post-market safety and adverse events, but are now beginning to use RWE to make regulatory decisions. The healthcare community is using RWE increasingly to support coverage decisions and to develop guidelines and decision support tools for use in clinical practice.

Our Real-World Evidence and Data Analytics (RWE/DA) team leverages data from sources such as medical charts, administrative claims data, electronic health records, registries, and government databases to answer questions about disease epidemiology, burden, treatment patterns, comparative effectiveness, and costs. The studies may also be used to populate and validate economic models, support strategic value messages, and integrate patient-reported outcomes (PROs) with other sources of data as appropriate.

Our ‘data agnostic’ approach ensures that we will aim to find the best dataset to meet your research question. This, along with our strategic insights on study design and innovative analyses, provide tailored, fit-for-purpose insights that demonstrate the real-world value of healthcare innovations and interventions.

Pre-clinical Development

Real-world data should be used early in the drug development process to inform target populations for clinical trials, estimate achievable sample sizes, and identify relevant clinical outcomes.

Phase I/II – Clinical

Early in clinical development is the best time to initiate studies that aim to characterize disease burden and unmet needs. These studies are critical for demonstrating to payers and other decision makers that they should invest in the condition of interest and its treatment.

Phase III - Clinical

During Phase III clinical development, current treatment patterns and cost drivers should be assessed to inform economic models and market access strategy. In addition, a post-marketing RWE strategy should be formulated to guide post-marketing activities.

Post-Approval

Following regulatory approval, RWE can be used to confirm clinical effectiveness, fulfill post-marketing efficacy and safety obligations, and assess comparative effectiveness of treatments. RWE is increasingly used in supporting label expansions to target new indications and patient populations.

Types of Real-World Data

Primary Data

Data collected by the investigator themselves for a specific purpose

Registry

Prospectively collected clinical data either from patient charts, clinicians, caregivers, and/or the patients themselves

Chart Review

Data collected by a study investigator and other staff from a patient’s paper or electronic medical chart

Survey

Data collected directly from respondents (clinicians, patients, and/or caregivers)

Secondary Data

Data collected by someone else from some other purpose

Registry

Use of an existing registry for research purposes

Claims Data

Data downloaded from electronic billing records in structured fields

Electronic Health Records

Data downloaded from electronic patient charts in structured fields, sometimes supplemented with curated free-text data

Why Us?

Our real-world data and analytics experts are actively involved in the field. We have the experience needed to guide you to the right solutions and be a partner in support your research.

RWE/DA Projects

Claims Database Analyses

Government Database Analyses