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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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Aug 12, 2024 | 
jamanetwork.com | Kushal Kadakia |Joseph S. Ross |Yale Collaboration
At-Home Testing for Survivors of Sexual Assault—Empowerment or Exploitation?
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Mar 7, 2024 | 
sojo.net | Joseph S. Ross
For Elijah McClain (1996-2019). Killed by police in Aurora, Colo., he was known as a gentle soul who played his violin to soothe anxious animals in shelters. If only a violin could redeem the world. Your skin, glowing like the violin’s wood, might still sing its humble lament. Read the Full Article You've reached the end of our free magazine preview. For full digital access to Sojourners articles for as little as $3.95, please subscribe now.
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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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Dec 19, 2023 | 
jamanetwork.com | Rohan Khera |Melissa A. Simon |Mélissa Simon |Joseph S. Ross
Automation Bias and Assistive AI: Risk of Harm From AI-Driven Clinical Decision Support At the point of care, artificial intelligence (AI) algorithms have been developed to augment diagnostic decisions and suggest appropriate care pathways,1 by leveraging complex information in a patient’s electronic health record, such as imaging, documentation, and diagnostic testing.
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Aug 21, 2023 | 
jamanetwork.com | Vinay K. Rathi |Joseph S. Ross |Rita F. Redberg
Unique Device Identifiers—Missing in Action Unique Device Identifiers for Medical Devices at 10 Years Sanket S. Dhruva, MD, MHS; Joseph S. Ross, MD, MHS; Natalia A. Wilson, MD, MPH Endovascular Aneurysm Repair Devices as a Use Case for Postmarketing Surveillance of Medical Devices Xuan Wang, PhD; Vidul Ayakulangara Panickan, MS; Tianrun Cai, MD; Xin Xiong, MS; Kelly Cho, PhD, MPH; Tianxi Cai, ScD; Florence T.
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Aug 9, 2023 | 
jamanetwork.com | Jennifer Kao |Joseph S. Ross |Jennifer Miller
Introduction The COVID-19 pandemic highlighted the importance of timely access to clinical trial results for public health. Despite decades-long efforts to improve results reporting for clinical research, problems persist.1 Trial investigators have 3 key platforms to disseminate results: trial registries,2 medical journals,3 and medical conferences. These platforms vary in their accessibility, scope, and depth.
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Jun 26, 2023 | 
jamanetwork.com | Meera Dhodapkar |Joseph S. Ross |Yale Collaboration |Reshma Ramachandran
Introduction In October 2022, the US Food and Drug Administration (FDA) announced the Split Real-Time Application Review (STAR) pilot program under the Prescription Drug User Fee Authorization Act VII.1 Like its predecessor, the Real-Time Oncology Review (RTOR) program for oncology drugs, STAR is designed to shorten regulatory review of supplemental new indication approvals of drugs and biologics that treat serious conditions with an unmet need.
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Jun 12, 2023 | 
jamanetwork.com | James Johnston |Joseph S. Ross |Reshma Ramachandran
Approval of Drugs With Unmet Trial End Points—In Reply FDA Approval of Drugs Not Meeting Pivotal Trial Primary End Points James L. Johnston, MD; Joseph S. Ross, MD, MHS; Reshma Ramachandran, MD, MPP, MHS Approval of Drugs With Unmet Trial End Points Indranil Bhattacharya, PhD; Iraj Daizadeh, PhD; Andrew S.
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May 15, 2023 | 
jamanetwork.com | Maryam Mooghali |Yale Collaboration |Joseph S. Ross |Kushal Kadakia
Availability of Unique Device Identifiers for Class I Medical Device Recalls From 2018 to 2022 For medical devices, the US Food and Drug Administration (FDA) designates the highest severity recalls as Class I, indicating a reasonable likelihood of serious adverse events or death occurring with use.1 For example, HeartWare Ventricular Assist Device System (Medtronic), which provides circulatory support for end-stage heart failure, was recalled multiple times between 2013 and 2022 for risks...
