Real‐World Evidence for Assessing Pharmaceutical Treatments in the Context of COVID‐19 von Franklin, Jessica M., Lin, Kueiyu Joshua, Gatto, Nicolle M., Rassen, Jeremy A., Glynn, Robert J., Schneeweiss, Sebastian

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SURF: A Screening Tool (for Sponsors) to Evaluate Whether Using Real‐World Data to Support an Effectiveness Claim in an FDA Application Has Regulatory Feasibility von Campbell, Ulka B., Honig, Nicholaas, Gatto, Nicolle M.

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A Structured Process to Identify Fit‐for‐Purpose Study Design and Data to Generate Valid and Transparent Real‐World Evidence for Regulatory Uses von Gatto, Nicolle M., Vititoe, Sarah E., Rubinstein, Emily, Reynolds, Robert F, Campbell, Ulka B.

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The Structured Process to Identify Fit‐For‐Purpose Data: A Data Feasibility Assessment Framework von Gatto, Nicolle M., Campbell, Ulka B., Rubinstein, Emily, Jaksa, Ashley, Mattox, Pattra, Mo, Jingping, Reynolds, Robert F.

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Causal identification: a charge of epidemiology in danger of marginalization von Schwartz, Sharon, PhD, Gatto, Nicolle M., PhD, Campbell, Ulka B., PhD

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Is the “well-defined intervention assumption” politically conservative? von Schwartz, Sharon, Prins, Seth J., Campbell, Ulka B., Gatto, Nicolle M.

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Describing characteristics and treatment patterns of patients hospitalized with COVID-19 by race and ethnicity in a national RWD during the early months of the pandemic von Vititoe, Sarah E, Easthausen, Imaani J, Lasky, Tamar, Chakravarty, Aloka, Bradley, Marie C, Roe, Laura M, Gatto, Nicolle M, Weckstein, Andrew R, Garry, Elizabeth M

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A Structured Preapproval and Postapproval Comparative Study Design Framework to Generate Valid and Transparent Real‐World Evidence for Regulatory Decisions von Gatto, Nicolle M., Reynolds, Robert F., Campbell, Ulka B.

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Organized structure of real-world evidence best practices: moving from fragmented recommendations to comprehensive guidance von Jaksa, Ashley, Wu, James, Jonsson, Pall, Eichler, Hans-Georg, Vititoe, Sarah, Gatto, Nicolle M.

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Real-world comparative effectiveness of mRNA-1273 and BNT162b2 vaccines among immunocompromised adults identified in administrative claims data in the United States von Mues, Katherine E., Kirk, Brenna, Patel, Deesha A., Gelman, Alice, Chavers, L. Scott, Talarico, Carla A., Esposito, Daina B., Martin, David, Mansi, James, Chen, Xing, Gatto, Nicolle M., Van de Velde, Nicolas

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Visualizations throughout pharmacoepidemiology study planning, implementation, and reporting von Gatto, Nicolle M., Wang, Shirley V., Murk, William, Mattox, Pattra, Brookhart, M. Alan, Bate, Andrew, Schneeweiss, Sebastian, Rassen, Jeremy A.

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Toward a Clarification of the Taxonomy of “Bias” in Epidemiology Textbooks von Schwartz, Sharon, Campbell, Ulka B., Gatto, Nicolle M., Gordon, Kirsha

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Availability of comparative real-world evidence research in Medicare patients: implications for Centers for Medicare and Medicaid Services drug price negotiations von Jaksa, Ashley, Arena, Patrick J, Gatto, Nicolle

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Heeding the call for less casual causal inferences: The utility of realized (quantitative) causal effects von Schwartz, Sharon, Gatto, Nicolle M, Campbell, Ulka B

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Categorization of COVID‐19 severity to determine mortality risk von Garry, Elizabeth M., Weckstein, Andrew R., Quinto, Kenneth, Bradley, Marie C., Lasky, Tamar, Chakravarty, Aloka, Leonard, Sandy, Vititoe, Sarah E., Easthausen, Imaani J., Rassen, Jeremy A., Gatto, Nicolle M.

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Treatment effectiveness in a rare oncology indication: Lessons from an external control cohort study von Oksen, Dina, Prince, Patricia, Boutmy, Emmanuelle, Garry, Elizabeth M., Ellers‐Lenz, Barbara, Estrin, Adina, Johne, Andreas, Verpillat, Patrice, Gatto, Nicolle M.

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Linking clinical trial participants to their U.S. real-world data through tokenization: A practical guide von Eckrote, Michael J., Nielson, Carrie M., Lu, Mike, Alexander, Tyler, Gupta, Rikisha Shah, Low, Kim Wah, Zhang, Zhiwei, Eliazar, Austin, Klesh, Reyna, Kress, Andrew, Bryant, Matt, Asiimwe, Alex, Gatto, Nicolle M., Dreyer, Nancy A.

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Risk of Perforation After Colonoscopy and Sigmoidoscopy: A Population-Based Study von Gatto, Nicolle M., Frucht, Harold, Sundararajan, Vijaya, Jacobson, Judith S., Grann, Victor R., Neugut, Alfred I.

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An Organizational Schema for Epidemiologic Causal Effects von Gatto, Nicolle M., Campbell, Ulka B., Schwartz, Sharon

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Lung Cancer-Related Mortality With Inhaled Insulin or a Comparator: Follow-Up Study of patients previously enrolled in Exubera Controlled Clinical Trials (FUSE) Final Results von Gatto, Nicolle M, Koralek, Daniel O, Bracken, Michael B, Duggan, William T, Lem, Joanna, Klioze, Sol, Koch, Gary G, Wise, Robert A, Cohen, Roger B, Jackson, Neville C

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