Real-World Evidence in Diabetes: Relevance to Clinical Practice Lawrence Blonde, MD; Timothy Bailey, MD; Jodi Strong, DNP; Philip Levin, MD
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SUPPLEMENT TO VOL 68, NO 3 / APRIL 2019 VIDEO ROUNDTABLE ABSTRACT Real-world Evidence in Diabetes: Relevance to Clinical Practice Lawrence Blonde, MD; Timothy Bailey, MD; Jodi Strong, DNP; Philip Levin, MD eal-world studies may be distinguished from tradi- evaluating the efficacy and safety of new therapeutic inter- tional randomized controlled trials (RCTs) based on ventions, they are typically conducted in specialized environ- Rthe study population and the setting in which the ments that may lack the everyday reality of clinical, home, research is conducted. While RCTs are the gold standard for and community settings. There is often a gap between effi- cacy shown in RCTs and the effectiveness observed in real- Lawrence Blonde, MD, Ochsner Diabetes Clinical Research world settings. Real-world studies and resultant real-world Unit, Frank Riddick Diabetes Institute, Endocrinology Department, data can be used to develop real-world evidence (RWE). Ochsner Medical Center, New Orleans, LA RWE adds to the evidence from RCTs by providing additional Timothy Bailey, MD, AMCR Institute, Escondido, CA results obtained from a broader patient population out- Jodi Strong, DNP, Ministry Medical Group, Stevens Point, WI side the constraints of RCTs to evaluate what is happening Philip Levin, MD, MODEL Clinical Research, Towson, MD in usual clinical practice. Thus, RWE is useful in determin- ing the effectiveness and safety of an intervention in clinical DISCLOSURES Dr. Blonde has received grants and research support from Janssen, practice, and it can also provide information on health care Lexicon Pharmaceuticals, Merck & Co, Novo Nordisk, and Sanofi. resource utilization and costs, which are not typically evalu- He has been on the speakers’ bureaus of AstraZeneca, Janssen, ated in RCTs. Novo Nordisk, and Sanofi. He has been a consultant for, and received honoraria from, Janssen, Merck & Co, Novo Nordisk, and Sanofi. The findings generated in real-world studies have greater Dr. Bailey has received research support from Abbott, Ambra external validity (the results are more generalizable to other Health, Ascensia, BD Biosciences, Boehringer Ingelheim, Calibra settings and to patients with more diverse characteristics) Medical, Companion Medical, Dance Biopharm, Dexcom, Eli Lilly, than traditional clinical trials. However, they may have less Glooko, Glysens, Kowa Pharmaceuticals, Lexicon Pharmaceuticals, MannKind, Medtronic, Novo Nordisk, Sanofi, Senseonics, TaiDoc, internal validity (the observed results being due only to the Versartis, and Xeris Pharmaceuticals. He has been a consultant for variable[s] being studied and not to some other confound- and received honoraria from Abbott, AstraZeneca, Ascensia, BD Biosciences, Calibra Medical, Capillary Biomedical, Eli Lilly, Intarcia ing factor[s]). Even after controlling for confounders, some Therapeutics, Medtronic, Novo Nordisk, and Sanofi. He has received confounding variables may remain in RWE and significantly speaker honoraria from Abbott, Eli Lilly, Medtronic, Novo Nordisk, limit the ability to establish cause-effect relationships. and Sanofi. The accompanying videos were developed to help health Dr. Strong has been on the speakers’ bureaus of AstraZeneca, Boehringer Ingelheim, Eli Lilly, Janssen, Novo Nordisk, and Sanofi. care professionals better understand the role and limita- She has been an advisory board member of Ascensia and Intarcia. tions of RWE relating to the provision of effective treatment Dr. Strong has been a consultant for the American Diabetes of patients with diabetes in everyday clinical practice. The Association and Novo Nordisk and has received authorship support from Novo Nordisk and Sanofi. speakers summarize the insights gained from some real-world Dr. Levin has been a consultant for Novo Nordisk and Sanofi. He studies of long-acting basal insulins, including data on hypogly- has been an advisory board member for Novo Nordisk and Sanofi. cemia and healthcare resource utilization. Topics of relevance Dr. Levin received research support from Amylin Pharmaceuticals, Eli Lilly, Merck & Co, Novo Nordisk, Roche, and Sanofi. He has been to practitioners who see patients with diabetes, such as medi- on the speakers’ bureaus of Amylin Pharmaceuticals, AstraZeneca, cation adherence and cardiovascular safety, are also discussed. Bristol-Meyers Squibb, Boehringer Ingelheim, Eli Lilly, Janssen, Novo Nordisk, and Sanofi. VIDEO The video roundtable associated ACKNOWLEDGEMENTS This roundtable was funded by Sanofi US, Inc. The authors received with this abstract can be found online writing/editorial support in the preparation of this material from Patricia at https://www.mdedge.com/content/ Fonseca, PhD, of Excerpta Medica, funded by Sanofi US, Inc. jfp-real-world-diabetes FINANCIAL SUPPORT The video roundtable was peer reviewed by MDedge Family Medicine. Financial support provided by Sanofi US, Inc. OCTOBER 2018 S1.