In part one of this blog series, IQVIA experts detailed the various real world evidence credibility frameworks. The second and final blog in this series, will uncover how to identify the right data.
A successful real world evidence (RWE) strategy should credibly answer the questions that will inform the decision-making process. First and foremost, it is important to understand who the stakeholder is that real world data (RWD) are being generated for. As part of this, it is critical to answer the following:
Clearly articulating the stakeholder’s current and long-term RWE needs will help determine the type of evidence that will inform decision making.
Many clinical and business questions can be answered by analyzing de-identified medical and pharmacy claims data. But depending on the research questions and patient population of interest, claims data are limited in the granularity and depth of clinical insights that can be generated. For these reasons, it is important to consider a broad range of data sources to address research questions and stakeholder needs (FIGURE 1).
Figure 1: The RWD value chain addresses evidence needs through a multi-sourced platform of healthcare data sources.
Additional RWD sources may include electronic medical records (EMRs), registries, labs and diagnostic data, genomic data, consumer data, patient reported outcomes (PRO) data from survey instruments, and actigraphy data from wearable devices.
Each of these data sources may provide information on different parameters of interest for the stakeholder. Some data sources may analyze as standalone data sets, and other data may be linked to provide richer context and longitudinal analysis of patients throughout their care journey, in different healthcare settings over time.
To address a broad set of research questions of interest around effectiveness, safety, health-related quality of life (HRQoL), and economic impact, a single RWD set is rarely sufficient. The true value of RWD comes from being able to connect disparate data sources, and in doing so, unlocking a more holistic picture of the patient journey. However, integrating these data sources presents several challenges.
In the wake of the COVID-19 pandemic, having an effective RWE strategy has taken on a new urgency. Carefully curated RWE can empower stakeholders, leveraging existing or bespoke RWD to enrich submission packages or drive corporate decisions. Data sources should be robust enough to enable accurate selection of a target patient population in sufficient quantities to meet sample size needs, capturing data in an accurate and timely manner, that is acceptable to regulators and payers. The linchpin for successfully executing RWD analysis is to clearly define the research questions and then evaluate different data sources based on their ability to provide credible answers.
A comprehensive, thoughtful analysis of RWD sources will ensure that stakeholder needs are exceeded.
If you missed the first post in this real world blog series that focuses on credibility frameworks, you can read it here.