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2 months ago | 
jacc.org | Harlan M. Krumholz |Joshua D. Wallach
IntroductionScientific publishing is transforming, and preprints are leading the charge. Preprints enhance the rapid communication of discoveries and insights by allowing researchers to share completed work before peer review. This approach complements peer review, which retains its importance, fostering collaboration and accelerating scientific progress.
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Aug 27, 2024 | 
jamanetwork.com | Maryam Mooghali |Yale Collaboration |Joshua D. Wallach |Joseph Ross
Key PointsQuestion What are the premarket end points and postmarketing requirements for US Food and Drug Administration (FDA) breakthrough therapy–designated approvals? Findings In this cross-sectional study of 157 original indications with breakthrough therapy designation, all accelerated approvals and 58% of traditional approvals were based on pivotal trials using surrogate markers as primary end points.
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Aug 21, 2024 | 
jamanetwork.com | Joshua D. Wallach |Joseph S. Ross |Samuel Yoon |Harry Doernberg
Surrogate Markers and Clinical Outcomes—Reply Surrogate Markers and Clinical Outcomes for Nononcologic Chronic Disease Treatments Joshua D. Wallach, PhD, MS; Samuel Yoon, BS, BA; Harry Doernberg, MM; Laura R. Glick, MD; Oriana Ciani, PhD; Rod S. Taylor, PhD; Maryam Mooghali, MD; Reshma Ramachandran, MD, MHS, MPP; Joseph S.
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May 1, 2024 | 
jamanetwork.com | Maryam Mooghali |Yale Collaboration |Ayman Mohammad |Joshua D. Wallach
Introduction The US Food and Drug Administration (FDA) launched the Real-Time Oncology Review (RTOR) program in 2018 to support earlier review of oncology therapeutics expected to be a substantial improvement over available therapy based on straightforward study designs and easily interpreted end points.1 Although RTOR applications have been associated with shorter median approval times,2,3 little is known about the evidence supporting RTOR indication approvals.
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Apr 22, 2024 | 
jamanetwork.com | Joshua D. Wallach |Samuel Yoon |Harry Doernberg |Laura R Glick
Associations Between Surrogate Markers and Clinical Outcomes for Nononcologic Chronic Disease Treatments Key PointsQuestion What is the strength of association between surrogate markers used as primary end points in clinical trials to support Food and Drug Administration (FDA) approval of drugs treating nononcologic chronic diseases and clinical outcomes?
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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.
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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.
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Feb 12, 2024 | 00033-7/fulltext?rss=yes&sz=64)
jclinepi.com | Tyler Pitre |Joshua D. Wallach |Dennis M Bier
This paper is only available as a PDF. To read, Please Download here. HighlightsKey findings•The analysis of nutritional epidemiology data is complex and there is often limited consensus among experts about the ideal approach.
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Feb 12, 2024 | 00033-7/fulltext&sz=64)
jclinepi.com | Tyler Pitre |Joshua D. Wallach |Dennis M Bier
Plain language summaryRandomized trials represent the optimal design for investigating the health effects of medical interventions. They pose important challenges, however, when it comes to studying the health effects of food and nutrition. Hence, investigators commonly perform nutritional epidemiology studies. These studies are observational in design, collect information from large groups of people, and look for patterns between their diet and their health.
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Dec 21, 2023 | 
medrxiv.org | Yumin Wang |Tyler Pitre |Joshua D. Wallach |Tanvir Jassal
Dr Wallach reported receiving grant support from the FDA, Arnold Ventures, Johnson & Johnson through Yale University, and the National Institute on Alcohol Abuse and Alcoholism of the NIH under award 1K01AA028258; serving as a consultant for Hagens Berman Sobol Shapiro LLP and Dugan Law Firm APLC; and serving as a medRxiv affiliate. No funding. I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.
