Peek Behind the Paper: the promise and peril of real-world evidence for medical product evaluation
Sanket Dhruva (University of California, San Francisco, CA, USA) discusses his 2018 Pharmacy and Therapeutics paper on the benefits and challenges of applying of real-world evidence to the proactive evaluation of medical products.
Please introduce yourself and your institution
I am an Assistant Professor of Medicine (Cardiology) at the University of California, San Francisco and a Staff Physician at the San Francisco Veterans Affairs Medical Center (both CA, USA).
“The ideal data source often means that multiple different data sources have to be combined”
What inspired you to write this article?
My co-authors and I were interested in writing this article because of our recognition of two simultaneous trends: first, the increasing importance of real-world evidence (RWE) to decision-making in multiple contexts — to regulators, payers, doctors and patients — and second, the rapid growth in volume of complex digital real-world data that can be used to generate RWE.
In the article, you discuss the ‘ideal data source’ — what currently available source of data comes closest to this and how do you think this might change in the future?
Unfortunately, there is really no “ideal data source”. The ideal data source usually depends on the specific question that we are interested in answering (e.g. what patient population, what intervention, and what outcomes, among other considerations).
All data sources are currently evolving and becoming stronger and richer sources of real world data, including the ability to use structured and even unstructured data from electronic health records, the exponential increase in mobile health applications, and the greater focus on data sharing such as from clinical trials, among other opportunities. The ideal data source often means that multiple different data sources have to be combined.
Why is it important that pharmacy and therapeutics (P&T) committees engage proactive medical product evaluation?
P&T committees should be engaged in proactive evaluation of medical products because FDA is increasingly employing a life-cycle approach to medical product regulation whereby there is greater reliance on post-market data generated in real-world clinical environments. To ensure that data are generated to answer the clinical questions around safety and effectiveness that are of importance to P&T committees and that will inform their decision-making, the committees should provide input and even help guide evaluations.
“…there is no ‘ideal data source'”
How can they keep up with the increasing availability and volume of real-world data?
The rapid growth of real-world data certainly presents interesting challenges. One key opportunity is for P&T committees to increase sharing and transparency of their evaluations of real-world evidence for different medical products. This can certainly help so that P&T committees can learn from each other’s expertise.