What is it?
There has been increasing interest in exploring the potential use of real-world data (RWD) to support decision-making in healthcare. To help explore how RWD can contribute to decision-making, an overview of stakeholder policies and perspectives on RWD was needed.
The GetReal project team has reviewed different stakeholders’ policies and perspectives on using RWD for early drug development and relative effectiveness assessment.
How was it created?
- A literature review was carried out that identified 50 documents from academic publications and grey literature (non-conventional publications and reports).
- Stakeholder interviews were conducted with 19 different stakeholders from 7 stakeholder groups: pharmaceutical industry, health technology assessment (HTA) agencies, regulatory agencies, healthcare payers or insurers, academia, RWD initiatives and patient organisations.
- Differing policies: stakeholder groups have different policies on RWD collection, partly because of their different goals and mandates. Policies on access to RWD available through pragmatic clinical trials, electronic health records and administrative claims databases, for example, vary dramatically between countries, regions, states and even between organisations. The steps that need to be taken by boards of governance to approve plans for real-world studies also vary according to the context of the studies.
- Cultural barriers: there is a cultural barrier among stakeholders that reduces the acceptability of real-world evidence (RWE) in drug development and relative effectiveness assessment. Many adhere to a hierarchy of evidence that prioritises data from randomised controlled trials (RCTs) over non-RCT data.
- Standardisation of data: the majority of authors and interviewees highlighted the lack of standardisation of RWD because it is collected for different purposes. They emphasised the need to standardise the types of RWD collected, and the methods and tools for collection and analysis. However, they also noted that stakeholders have different goals and mandates that affect what data are collected and the strengths and limitations of the data. Some authors and stakeholders stated that vast amounts of RWD are already available, for example, through health surveys, observational studies and administrative claims databases.
All of these factors contribute to scepticism towards RWD and prevent its use in drug development or relative effectiveness assessment.
Amr Makady and Wim Goettsch, Zorginstituut Nederland (ZIN)