Panelists Advocate for Global Collaboration in RWE Effort

Global collaboration plays an important role in generating real world evidence (RWE), and these consultations must involve countries in the developing world as well as corporate stakeholders to actively aid in health care decision making, said panelists during the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) annual meeting, Virtual ISPOR 2020, held this week.

RWE has “appeared to promise solutions that would completely revolutionize the way we generate evidence for new drugs and at the same time offer both a faster and better evidence basis to the key institutional decision makers,” said Pall Jonsson, BS, MRes, PhD, associate director of Research and Development atthe National Institute for Health and Care Excellence, in Manchester, United Kingdom.

“At the same time, those who are more skeptical emphasize the potential pitfalls of using nonrandomized data and have highlighted issues such as the difficulties of establishing causal inferences, for instance, through such issues as data quality and the potential bias and confounding that you might find in such datasets,” he said.

Challenges Overcome

Advances in generating and synthesizing data into evidence have overcome some of those challenges, Jonsson said. And many organizations have moved forward with efforts to obtain value from RWE. This includes the GetReal Initiative, a European Union partnership with the pharmaceutical industry with a mission to facilitate the adoption and implementation of RWE in drug development and healthcare decision making.

The ISPOR panel represented members from the GetReal Initiative Think Tank, a multi-stakeholder group of European and US RWE experts from government, industry, and the health care community.

“The think tank with this multisector background will help us work out how we can develop consensus and guidance on both key policy and technical challenges facing RWE generation and views,” Jonsson said.

In order for global collaboration to be successful, panelists said, ideas from lower- and middle-income countries must be incorporated in addition to input from higher-income countries. In fact, the coronavirus disease 2019 (COVID-19) pandemic has demonstrated that wealthier countries may be at a loss for dealing with this health care crisis, said panelist, Bart Barefoot, JD, director of Value Evidence & Outcomes and Real-World Evidence Policy and Advocacy at GlaxoSmithKline in London, United Kingdom.

“I think that 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.

The Role of Stakeholders

Although product sponsors make decisions on how data are collected, outside stakeholders including payers, health technology assessment organizations, regulators, patients, academics, and developers of health care interventions can all influence those decisions, said Barefoot.

“Consortia approaches allow us to learn from each other. Most importantly, from the industry perspective, to achieve buy-in from decision makers, they must be on the journey with us. Or, to put it another way, we must be on the journey with them and working collaboratively,” he said.

Monetary and Time Constraints of Data

Additionally, global collaboration shouldn’t be competitive and should welcome the sharing of data, despite this being an age where data are considered commercial, said panelist Alison Bourke, BSc, MSc, FRPharmS, scientific director for IQVIA in London.

“We tend to sell data and expertise and consultancy,” she said of IQVIA. “And because we sell it, it seems a bit strange going along to a collaboration and sharing that data [but]…what you're looking for is trying to get views aligned, or at least overlap, in order to advance that RWE acceptance. What's really important is a trusting environment that is noncompetitive.”

Bourke and Barefoot both mentioned that these initiatives can be time consuming, especially if a large group of people are involved and have different objectives. Huge variation in geography, health care delivery systems, law, and culture can all prolong the process as well.

“These meetings are meant to be a safe space, and no comments are attributed to a person. In fact, we encourage debate, because for those particularly challenging areas we really want to dig into what is the crux of the problem and how can we build consensus,” said panelist Nirosha Mahendraratnam Lederer, PhD, who manages the Real-World Evidence Collaborative at the Duke-Margolis Center for Health Policy, in Washington, DC.

Overcoming Skepticism

Not all countries and stakeholders may be looking for the same conclusions, or they may be more skeptical of RWE, said Jónsson.

“I think we need to recognize that not all countries and stakeholders are traveling at the same speed, and this needs to be understood and taken into account.… An environment for robust conversation is really needed, and that includes both those who are very pro [RWE] and also those who are more skeptical,” he said.

Visit The Center for Biosimilars' conference page for more about Virtual ISPOR 2020.