In the past year, we have witnessed a tangible shift in the clinical research community with respect to 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 fourth in Jeff Trotter’s five-part blog series: Predictions in Real-World Evidence for 2021.
Prediction #3: Improving the strategic foundation for RWE across the development spectrum
From clinical development all the way through to commercialization, real-world evidence is proving to be a valuable resource. At this point, however, we need to make a clear distinction: RWD ≠ RWE.
For those of us formulaically inclined, I propose the following:
RWE = RWD + I
Real-World Evidence = Real-World Data + Intent
While not complex, it’s imperative we remember that data is of little use unless you can express the intent for its application. In my experience, much of the organizational discomfort and inefficiency our sponsors experience with respect to real-world data can be traced back to a failure to articulate a clear intention for how the data will be employed. The strategic purpose for RWD provides the critical context for its use as documentation (i.e., evidence) of real-world utilization, impact, and outcomes.
Thus, the strategic purpose, once identified and articulated, becomes the foundation that is essential to establishing an appropriate operational plan for generation of RWD. Only after the intention is in place can you develop a suitable approach, be it retrospective, prospective, or hybrid.
We’re happy to see a significant increase in the number of life sciences companies who are embracing long-term strategy earlier in their product development timeline. This early-stage strategic planning is the space where real-world evidence becomes a crucial resource.
As a document, the strategic plan is an effective tool for governing the entire development continuum, from clinical investigation through to commercialization. For example, as clinical study protocols increasingly incorporate accommodations for alternative designs (e.g., virtual trials), commercial implications are included among the factors to be considered. Strategic planning not only reinforces the finish line but also is the running start a sponsor needs to meet its objectives.
With a clearly defined intention, you can develop an effective strategy that guides all operational decisions. This strategy will help determine the optimal processes and tools to be deployed along the journey of development and commercialization.
How do you see the real-world evidence space developing in the next 12 months? Come back for the last installment in our blog series to read Jeff’s fourth and final prediction for RWE in 2021.
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Contact us today. Whatever the scope of your project, you can depend on our dedicated and accessible team to partner with you on your development journey.
