MedicalResearch.com Interview with:
Michael Fralick, MD FRCPC
Research Fellow at the Division of Pharmacoepidemiology and Pharmacoeconomics
Harvard University and
General Internist at the University of Toronto
MedicalResearch.com: What is the background for this study?
Response: Manufacturers of Food and Drug Administration (FDA)-approved prescription drugs often apply for additional indications based on randomized trials. “Real-world” data based on a medication’s actual use and outcomes in routine settings of care might help to inform decision-making regarding such supplemental indications.
MedicalResearch.com: What are the main findings?
Response: In this non-randomized study we were able to replicate the results of the randomized trial that established the supplemental indication for telmisartan using data from a US healthcare database (insurance claims data) available at the time the randomized trial was completed.
We were also able to confirm the known decreased risk of angioedema with telmisartan compared to ramipril.
MedicalResearch.com: What should readers take away from your report?
Response: If done selectively and with principled methodologies, it might be feasible to use non-randomized real-world data to provide supportive evidence in establishing supplemental drug indications. To improve the validity of the studies, they should ideally be registered prior to them starting.
MedicalResearch.com: Is there anything else you would like to add?
Response: We used real-world data to recreate both the benefits and the harms found in a randomized controlled trial. The randomized trial costed 10s of millions of dollars and took over 7 years to complete. By contrast, our study took a few months to complete and was a small fraction of the cost of the randomized trial.
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Michael Fralick, Aaron S. Kesselheim, Jerry Avorn, Sebastian Schneeweiss. Use of Health Care Databases to Support Supplemental Indications of Approved Medications. JAMA Intern Med. Published online November 20, 2017. doi:10.1001/jamainternmed.2017.3919
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