2020 Predictions in Real-World Evidence, Part 3: The Renewed Importance of Documentation

Uncategorized, Real world evidence, real world data


As appreciation grows for the contribution of real-world evidence (RWE) and real-world data (RWD) to clinical research, the application of RWE/RWD within this space is treated with circumspection. To help stakeholders confidently explore the benefits of adopting real-world evidence applications, Jeff Trotter, Senior Vice President, Worldwide Evidence, has been identifying key trends within the industry.

This is the third post in Jeff Trotter’s five-part blog series, “2020 Predictions in Real-World Evidence.” Read his first prediction here.

Prediction #2: The Renewed Importance of Documentation

In what’s being called the “post-truth” era, we need more steak and less sizzle. Healthcare is too important to be cavalier in patient treatment or in the drug and device development space. In both our methods and our discourse, it is incumbent upon us to give documented evidence and eliminate any cause for doubt in our claims. If we truly want to establish the value of drugs and devices—and put appropriate concerns over inappropriate pricing in perspective—we need to reaffirm the importance of using appropriate scientific methods to generate useful, persuasive, impactful data.

Regulatory and quasi-governmental agencies are articulating more defined expectations over real-world data as the basis for assertions of real-world value. In light of these conditions, I envision life sciences companies affording greater autonomy and authority to internal teams in 2020, to the extent that even the most seemingly benign story may not go unsubstantiated. I’m not willing to go as far as to suggest we’ll see internal independent watchdogs at this point, but that might be an interesting concept to explore.

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.

What do you foresee as trends in real-world evidence 2020? Come back for the next installment in our blog series to read Jeff’s third prediction for 2020.

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