Nicolle M Gatto

11PUBLICATIONS
35CO-AUTHORS
Data qualityMolecular targetsMajor global burdens of diseaseClinimetricsCommercial law
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Publications (11)

|Sep 25, 2025
Combining Real-World and Clinical Trial Data Through Privacy-Preserving Record Linkage: Opportunities and Challenges-A Narrative Review.

Michael Batech, Ann Madsen, Nicolle Gatto

|Jul 18, 2025
Hope is Not a Strategy: Using Robust Real-World Evidence to Make Better Clinical Development Decisions.

Nicolle M Gatto, Ulka B Campbell

|Jan 14, 2025
Advancing Principled Pharmacoepidemiologic Research to Support Regulatory and Healthcare Decision Making: The Era of Real-World Evidence.

Rohini K Hernandez, Cathy W Critchlow, Nancy Dreyer

|Oct 10, 2023
Availability of comparative real-world evidence research in Medicare patients: implications for Centers for Medicare and Medicaid Services drug price negotiations.

Ashley Jaksa, Patrick J Arena, Nicolle Gatto

|Aug 08, 2023
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.

Ulka B Campbell, Nicholaas Honig, Nicolle M Gatto

|Mar 05, 2023
A Structured Process to Identify Fit-for-Purpose Study Design and Data to Generate Valid and Transparent Real-World Evidence for Regulatory Uses.

Nicolle M Gatto, Sarah E Vititoe, Emily Rubinstein

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Frequent Collaborators

3 joint publications

Jeremy A Rassen

3 joint publications

Ulka B Campbell

3 joint publications

Sarah Vititoe

2 joint publications

Ashley Jaksa