In the past year, we have witnessed a tangible shift in the clinical research community with respect to the application of real-world evidence (RWE) and real-world data (RWD) in drug development and commercialization. As we prepare to harness the potential of RWE and RWD to advance business opportunities for our sponsors and to improve healthcare for patients, life sciences companies must identify areas for growth and refinement in this space. To help us identify opportunities and trends, Jeff Trotter, Senior Vice President, Scientific Solutions, Real-World Evidence, is sharing his predictions for developments in RWE and RWD for the year ahead.
This is the first in Jeff Trotter’s five-part blog series: Predictions in Real-World Evidence for 2021.
Real-World Evidence 2020 Trends in Review
It would be easy to take a complete pass on assessing my predictions from last year, coming as they did in that relatively blissful time just before COVID-19 disrupted all our best-laid plans. Nevertheless, notwithstanding the pandemic and the tumultuous time we’re now living through, I have revisited my predictions for 2020. Here’s how I grade myself on anticipating what would transpire, in light of how the year actually played out.
2020 Prediction #1—RWD is no longer just for demonstrating value: 9/10. Prior to 2020, our clients in life sciences were seeking real-world data primarily to gauge clinical effectiveness as a factor in determining the overall costs associated with their respective drug or device. This data was serving as a resource to inform payers of the effectiveness and impact of a given therapy under real-life conditions, in contrast to its performance as documented under the controlled conditions of clinical trials. Arguably, the handwriting was already on the wall for 2020, when we saw an increase in the use of RWD for protocol optimization and patient identification, and also as a simulated control arm. I might add that these efforts were not always successful, but methods and data supporting such applications are already improving. On this prediction, I score myself 9/10.
2020 Prediction #2—The renewed importance of documentation: 7/10. A year ago, I wrote: “I expect we’ll see greater emphasis on clarity in communications so that transparency and candor – particularly regarding the analytical limitations of real-world evidence – become hallmarks of integrity and responsible citizenship within the healthcare community.” In such a very non-truthy time as then, I may have been a little over-enthusiastic about the importance of true evidence; I can’t say I saw as much progress in this direction as I would have liked. I was hoping to see progress that continued to underscore the essentialness of facts in healthcare. While I did not see a decrease in standards for truth and documentation, I still see too much room for interpretation and spin, where one person’s evidence is still another person’s hyperbole. In the interest of maintaining the highest expectations, I can’t give myself more than 7/10 on this one. I know we can do better!
2020 Prediction #3—Meet the CDO: 5/10. Generally, life sciences organizations tend to be relatively slow in adapting to, or even anticipating, important industry shifts. From an organizational perspective, the potential leverage of RWD and RWE in therapeutic development merits serious consideration. As the sources of RWD have been expanding from data generated retrospectively to prospective initiatives, it appeared to me that the concept of the Chief Data Officer was becoming a crucial adaptation. I continue to maintain that organizations must embrace the idea of a key leadership position whose responsibility is to amplify RWD potential by bridging the gaps between traditional organizational silos. At this point, I do see philosophical shifts in organizations as they accommodate some form of real-world evidence center of excellence. However, these shifts are taking place at philosophical, rather than structural, levels. We still have work to do in establishing real-world evidence as meritorious of organizational shift. On this prediction, I’m giving myself 5/10. I thought things would happen more quickly.
2020 Prediction #4—Evolving service providers: 8/10. Life sciences organizations, rightly so, expect more from their traditional vendors. In turn, vendors are seeing their business models challenged by new kids on the block. These newcomers are more technologically advanced, and their solutions and ideas are gaining credibility among their target clients. Research organizations, perhaps encouraged and emboldened by a new era of regulatory openness, are exploring new approaches to RWE and RWD. These organizations are embracing sources of data – some virtual – and they are expanding their skill sets to include advanced analytical approaches. Life sciences companies are seeing an expanding range of vendor options at their disposal and are becoming more refined in their selection process. While there may yet be too much variability in data quality and consistency, I think everyone’s eyes are wide open to the shift that is happening. On this prediction I feel a lot better, so I’m giving myself 8/10.
How do you see the real-world evidence space developing in the next 12 months? Come back for the next installment in our blog series to read Jeff’s first prediction for RWE in 2021.
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