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 final installment in Jeff Trotter’s five-part blog series: Predictions in Real-World Evidence for 2021.
Prediction #4: Continued organizational “bridging” due to RWE and RWD
I offer this prediction as a follow-up to one of my predictions for last year, Meet the CDO. Since the notion of Chief Data Officer hasn’t yet gained the traction I predicted, I will reach a little lower for 2021 and simply acknowledge the trend toward an organizational shift due in part to the uniting effect of RWD and RWE.
In the life sciences company, this shift is reflected in a renewed and expanded mission for Medical Affairs, as this department essentially serves as the bridge between the clinical and commercial landmasses within the organization. Controlled clinical research will remain crucial for establishing product safety and efficacy, and commercial teams continue to carry the responsibility of sustaining, and accelerating, market uptake. Between these two dynamics, the medical affairs team can facilitate the transition from clinical development to the real-world setting that is the product’s intended objective. You could argue that the medical affairs section owns the RWD and RWE functionality, or to borrow a phrase from an earlier prediction, the RWE Center of Excellence.
There is opportunity for the Medical Affairs group in an organization to achieve continuity of science and strategy, while bridging the gaps that persist in training and perspectives. Situating RWD and RWE firmly within the organization ensures that neither science nor strategy is compromised, and thereby, the mission of bringing innovation to patient care is actually enhanced.
I’m interested to see where this organizational evolution takes us. I haven’t let go of the concept of a Chief Data Officer, but for now, I see Medical Affairs, and arguably the HEOR department, as the bridge between science and commercialization.
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