Expert panellists have called for a global effort to harmonise the acceptance of Real World Evidence (RWE), to aid clinical and healthcare decision-making, during the International Society for Pharmaco- economics and Outcomes Research (ISPOR) virtual meeting last month.
Real World Data, originating from a variety of sources including electronic health records, has for some time been promised as a data source capable of optimising the patient experience and accelerating clinical research. However, a number of very real shortcomings exist, that have hindered the use of RWE to support submissions.
We recently caught up with Ramon Hernandez, Head of RWE data and analytics at Sanofi, to talk about the regulatory limitations of using RWE for simulated clinical trials. You can read that interview here.
The challenges already overcome
Recent advances in technologies to collect and gather RWD, have meant that the challenges have matured to predominantly demonstrating the value of RWD. To do so, programmes such as the GetReal Initiative, established by a European Union partnership, have sprung up to support the pharmaceutical industry in the adoption and implementation of RWE.
Bart Barefoot, Director of Value Evidence & Outcomes and RWE Policy & Advocacy at GSK, explained how having international, multi-sector representation in think tanks such as GetReal, can help to advance the policy and technical challenges we face in using RWE.
A timely example is that of COVID-19, where some developed countries were significantly less prepared and less-resourced to deal with the public health crisis than their poorer counterparts. “This really illustrates how countries and regions that are maybe objectively considered higher income or better resourced don’t necessarily have better approaches or better answers than countries or regions that are considered lower middle income. So, I think we all have a lot to learn from one another,” he said. Global collaboration is essential for success in RWE implementation.
The role of stakeholders
Likewise, consortiums such as GetReal, show how important the inclusion of outside stakeholders is. These stakeholders may be regulators, health tech assessment groups, academics, payers and patients. Understanding the perspectives of each sector individually will ultimately help to achieve decision-maker buy-in.
Creating a non-competitive space
Despite it being in a highly competitive space, we must increase the sharing of data between relevant parties, where possible, if we are to advance RWE acceptance. Panellist Alison Burke, Scientific Director for IQVIA, explained that creating these initiatives which aim to create a trusting environment to share data can be time-consuming. Different stakeholders usually have conflicting objectives, not to mention differences in healthcare systems, policy, law and culture.
How do we overcome scepticism?
Páll Jónsson, Associate Director of R&D at NICE, explained during the session that some geographies or sectors may have different endpoints in mind with using RWE: “I think we need to recognize that not all countries and stakeholders are travelling at the same speed, and this needs to be understood and taken into account.… An environment for robust conversation is needed, and that includes both those who are very pro [RWE] and also those who are more sceptical”.
Image Source: Talkingmedicines