A new frontier: Transforming real world evidence for physicians
There is a vital need to involve physicians, build trust in real-world evidence (RWE), and promote collaboration among stakeholders for improved patient care and research efficacy
Physicians are on the front line when it comes to treating patients. They are often in the best position to improve patient care. And many believe that giving physicians greater access to real world evidence (RWE) will only help them make better-informed treatment decisions for the benefit of their patients.
RWE -- medical evidence generated during patient care, such as hospital review charts and electronic medical records (EMRs) – yields insights into what actually happens in everyday practice and creates a patient journey, or history, that provides important background for a physician determining a patient’s treatment.
Pharmaceutical companies should generate and transform RWE for the benefit of physicians, using technology to better enable physician-centered research. But they face a number of barriers, including the physicians’ lack of time to do much other than meet with their patients.
Engaging physicians
The key for pharma is to drive a dialogue with physicians to show them how RWE and data can be used in real time to directly benefit their patients.
“It’s important to engage physicians and the rest of the health care team on this topic. The data are coming from health care settings in the real world. But we also must understand the challenges that physicians face, what they care about, and how they can align their incentives with other folks’ incentives across the health care sector,” says Jason Lott, Vice President Global Integrated Evidence Generation, Specialty Medicine, Integrated Care, at Bayer.
“The health care community hasn't been as engaged in real world evidence topics from the biopharma side as we would like them to be. Physicians are first and foremost caring for the patients in front of them. We have to understand that perspective and always anchor ourselves in terms of the delivery of safe and effective patient care that recognizes the complexity of these health care systems and environments that physicians are living in,” he adds.
“We certainly want to understand what (the physicians’) workflows are like, and what (the physicians’) processes are like from a technology perspective,” says Lauren Becnel, Head of Real World Evidence, Evidence Generation Platform, at Pfizer. “We want to create a virtuous cycle in which we are starting to realize some of the goals that have been laid out by the FDA.” (In August 2023, the Food and Drug Administration finalized guidance on real-world evidence in drug approvals.)
Becnel wants to make the use of RWE “smooth and easy” for physicians. But for physicians to use the data, it has to be meaningful. “That means that it has to have a semantic set of meanings. We have to understand anyone who creates or uses it. What does this term, or what does this data element mean? And then we have to have syntactic agreement. How is it structured? Is it numbers, or is it text?
“The way that we talk about similar concepts can differ dramatically. So we're very interested not only in tackling the process and the people perspective, but also how to create that shared meaning in a way that's not disruptive of clinical care,” she explains.
Barriers ahead
But there are barriers to be overcome. “We want clinical trials to be simple, faster, and close to the real world, but it's hard to do that. Bringing a programmatic component into a clinical trial is hard, but that's the direction we want to go -- to combine clinical care with clinical research and the clinical trial,” says Xia Wang, Head of RWE Early Solutions, Global Real World Evidence and Digital Sciences, at UCB.
Wang believes that physicians play a key role in bringing clinical research into the clinical care world. She is concerned about motivating and supporting them, and providing them with data that is meaningful and which will help them make treatment decisions. “We need data that is really good and high quality data that we can trust as a good foundation to do that research,” she adds.
Another issue involves how some physicians may not trust the evidence and data because they don’t know how it’s being assimilated, or they believe that there are gaps in the data, according to Sajan Khosla, Executive Director, Head of Real World Evidence, at AstraZeneca.
“But once you start to iterate and cycle with the clinicians and show them where the gaps are and how the data can be used in real time…that erodes the barriers. Ultimately, that starts the conversation as to using those systems to help us in different dynamics. This is the opportunity that we have to start to erode the barriers,” he adds.
Becnel concurs with Khosla that many physicians do not trust the data. She indicates that establishing a set of standards around RWE and data would give them more confidence that RWE and data can be trusted.
Becnel also is concerned that many of the data elements that are needed aren't necessarily now used in care. “For research in oncology, we desperately care about things like progression and response, as do physicians. But not in every system are those things collected as independent and unique, discrete data. They're in images and other forms of data.”
Structure key elements
Researchers rely on human beings, automation, and natural language processing to power the deep review of medical records to gather those data elements, according to Becnel. It would be helpful to structure the key elements that are going to be drivers of research outcomes, while at the same time helping physicians understand their own patient outcomes, without disrupting the workflow.
Becnel indicates that a coalition comprised of physicians with available time, scientists, and other cross-functional parties who share an end goal of improving the health lives of patients, could work together to get the right processes in place.
Charting challenges
Lott believes that charting also is an issue. “Unfortunately, the chart became as much about supporting billing as it was charting accurate information. I certainly understand the skepticism that folks have with respect to data, knowing in real time that you have lower fidelity data.”
He says biopharmaceutical companies should partner with other health care system stakeholders to identify the barriers that physicians, care givers, and patients are facing, and to better understand the diffusion of technology. They could play an important role in helping to adopt common data standards, deploying technology to the EMR, innovating in the chart, and capturing standardized data elements.
“We need to find a mechanism whereby these EMR systems are not seen as administrative systems, but as capabilities and tools to help them to have scaled care,” adds Khosla.
A vision needed
“We need to set up the framework. It seems like we're all tackling the same barriers from different angles,” says Khosla, who feels it’s important to determine an objective and vision as to how to use data for research and clinical purposes and ensure that physicians and researchers trust the data. “How do we make sure that we're incentivizing the use of data in a way that it can be utilized?” he asks.
Wang explains that it is important to understand the patient journey and disease progression, and that’s where RWE and data come into play. In the end, building trust, understanding, and collaboration between pharma and physicians will lead to new data and the greater use of technology that eventually may lessen a physician’s workload, she notes.
Lott indicates that physicians can be motivated and incentivized by feedback from patients and other stakeholders that can help physicians understand what type of care they’re delivering. It also would be helpful for physicians to see that the data will be used to understand disease better, who should be receiving therapy, and to tackle the pragmatic challenges facing physicians and other health care providers daily.
Working with individuals
But technology and automation alone may not always make RWE and data available to physicians, according to Becnel. Many times, it will require working with individuals on a one-on-one basis. Often it will require a mix of technology and individual support.
Lott sees opportunities in getting the attention of physicians by applying algorithms to real word data, for example from EMRs, for modeling purposes. The models might show the results for patients if they received alternative treatments or no treatment at all.
Biopharma should further calibrate clinical trials to reflect the real world for patients and physicians. “How can we deploy tokenization to have a seamless transition from the trial into the real world? That experience can be captured in a way that extends the external validity, generalizability, and transportability of these trial results,” Lott says.
“I think we can make intentional efforts to further that trust. Physicians will have a greater choice and more willingness to partner in innovative approaches which marry real world data with primary evidence generation and (clinical) trials,” Lott explains.
“That’s a new frontier. We’re seeing a confluence of regulatory changes, of the methods, the technology, the data standardization, and the algos (algorithms). Now we move on to see how we can further that trust at the physician level and take the next step in terms of how we're generating evidence,” Lott adds.