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 third in Jeff Trotter’s five-part blog series: Predictions in Real-World Evidence for 2021.
Prediction #2: Greater clarity and comfort with the use of RWD in clinical development
Real-world data continues to gain acceptance by regulators, and sponsors are becoming increasingly motivated to be more rapid and more cost efficient in clinical development. These two drivers are spurring clinical operations professionals, albeit in some cases reluctantly, toward a higher level of comfort with alternative development processes.
Real-world data can be used to identify sites and patients best suited to specific clinical trials. It can also serve as a resource for fine-tuning a study protocol to reflect more accurately the conditions under which a developmental product would be used in actual medical practice. In fact, many life sciences companies are now seeking out RWD. Some are now generating the data as an end unto itself through prospective natural history studies. This data may also be applied as a mechanism for setting up the clinical development program or for refining its protocols. We at Worldwide have been involved in several observational studies conducted prior to Phase I launch.
The challenge remains for clinical operations professionals to adapt to the new ways we are able to leverage real-world data. Think of it like the sound – or lack thereof – of an electric car: the absence of the roar from an internal combustion engine can be disconcerting at first, but the silence doesn’t mean the vehicle is not working. Likewise, professionals coming into the RWD space, having grown comfortable with the processes required by controlled clinical experiments, may feel the RWD approach to be lacking in structure by comparison. In fact, it can be a mistake to try to impose too much structure on a real-world study, as the structure may have an undesired impact on the quality of the data they are seeking to gather.
Such undesired effects are often manifest in the unrealistic expectations that may be set for data quality and for classic monitoring practices. For example, patient-reported data is intrinsically incompatible with the expectation of 100% source data verification that is standard for randomized clinical trials. That’s not to say that RWD is subject to chaos: to define appropriate processes and ensure compliance thereof, clinical development teams and service providers will have to agree on bespoke standard operating procedures. In practice, we have found that these customized SOPs go a long way in establishing a common ground, which reassures all stakeholders that data quality is not being compromised.
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 third prediction for RWE in 2021.
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