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.
The Renewed Importance of Documentation
Inadequate/inaccurate case histories form the second most commonly cited deficiency in US-FDA inspections of clinical investigator sites.
Similarly, source documentation issues ranked 5th among the top 10 findings from European Medicines Agency (EMA) inspections of investigator sites in 2009 and in some instances the findings were classified ‘critical’. Not surprisingly, clinical trial monitors and auditors also report documentation issues as a frequent area of GCP concern.
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, life sciences companies are affording greater autonomy and authority to internal teams in 2020, to the extent that even the most seemingly benign story may not go unsubstantiated.
We will get to 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.
