Guneet Janda

Feb 12, 2024 | jamanetwork.com | Guneet Janda |Joshua D. Wallach |Joseph S. Ross |Meera Dhodapkar

Hypothetical Assessments of Trial Emulations—Reply Feasibility of Emulating Trials Supporting Approvals of Drugs and Biologics Guneet S. Janda, BS; Joshua D. Wallach, PhD, MS; Meera M. Dhodapkar, BA; Reshma Ramachandran, MD, MPP, MHS; Joseph S. Ross, MD, MHS Hypothetical Assessments of Trial Emulations Sebastian Schneeweiss, MD, ScD; Shirley V.

Feb 12, 2024 | jamanetwork.com | Sebastian Schneeweiss |Shirley Wang |Guneet Janda |Joshua D. Wallach

Hypothetical Assessments of Trial Emulations Feasibility of Emulating Trials Supporting Approvals of Drugs and Biologics Guneet S. Janda, BS; Joshua D. Wallach, PhD, MS; Meera M. Dhodapkar, BA; Reshma Ramachandran, MD, MPP, MHS; Joseph S. Ross, MD, MHS Hypothetical Assessments of Trial Emulations—Reply Guneet S. Janda, BS; Joshua D. Wallach, PhD, MS; Joseph S.

Oct 2, 2023 | jamanetwork.com | Guneet Janda |Joshua D. Wallach |Meera Dhodapkar |Reshma Ramachandran

Feasibility of Emulating Clinical Trials Supporting US FDA Supplemental Indication Approvals of Drugs and Biologics The US Food and Drug Administration (FDA) has developed a framework to use data gathered outside of clinical trials (eg, electronic health record [EHR] and insurance claims data) for evaluations of medical product safety and effectiveness.1 These methods, typically characterized as target trial emulations,2,3 are expected to be most useful for evaluating new clinical indications...