Search Results - "Federico, Carole"

A systematic review and meta-analysis of pregabalin preclinical studies by Federico, Carole A., Mogil, Jeffrey S., Ramsay, Tim, Fergusson, Dean A., Kimmelman, Jonathan

“…Despite large efforts to test analgesics in animal models, only a handful of new pain drugs have shown efficacy in patients. Here, we report a systematic…”
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Unreliable LLM Bioethics Assistants: Ethical and Pedagogical Risks by Goetz, Lea, Trengove, Markus, Trotsyuk, Artem, Federico, Carole A.

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Preclinical efficacy studies in investigator brochures: Do they enable risk-benefit assessment? by Wieschowski, Susanne, Chin, William Wei Lim, Federico, Carole, Sievers, Sören, Kimmelman, Jonathan, Strech, Daniel

“…Human protection policies require favorable risk-benefit judgments prior to launch of clinical trials. For phase I and II trials, evidence for such judgment…”
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Trials that say “maybe”: the disconnect between exploratory and confirmatory testing after drug approval by Carlisle, Benjamin, Federico, Carole A, Kimmelman, Jonathan

“…Clinical trials that explore the repurposing of drugs for off-label uses are common. But without a commitment to rigorously testing the hypotheses generated by…”
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Developer Perspectives on Potential Harms of Machine Learning Predictive Analytics in Health Care: Qualitative Analysis by Nichol, Ariadne A, Sankar, Pamela L, Halley, Meghan C, Federico, Carole A, Cho, Mildred K

“…Machine learning predictive analytics (MLPA) is increasingly used in health care to reduce costs and improve efficacy; it also has the potential to harm…”
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Response to Moisset et al by Federico, Carole A., Mogil, Jeffrey S., Ramsay, Tim, Fergusson, Dean, Kimmelman, Jonathan

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Biomedical Data Science, Artificial Intelligence, and Ethics: Navigating Challenges in the Face of Explosive Growth by Federico, Carole A, Trotsyuk, Artem A

“…Advances in biomedical data science and artificial intelligence (AI) are profoundly changing the landscape of healthcare. This article reviews the ethical…”
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A meta-analysis of threats to valid clinical inference in preclinical research of sunitinib by Henderson, Valerie C, Demko, Nadine, Hakala, Amanda, MacKinnon, Nathalie, Federico, Carole A, Fergusson, Dean, Kimmelman, Jonathan

“…Poor study methodology leads to biased measurement of treatment effects in preclinical research. We used available sunitinib preclinical studies to evaluate…”
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Ethical and epistemic issues in the design and conduct of pragmatic stepped-wedge cluster randomized clinical trials by Federico, Carole A., Heagerty, Patrick J., Lantos, John, O'Rourke, Pearl, Rahimzadeh, Vasiliki, Sugarman, Jeremy, Weinfurt, Kevin, Wendler, David, Wilfond, Benjamin S., Magnus, David

“…Stepped-wedge cluster randomized trial (SW-CRT) designs are increasingly employed in pragmatic research; they differ from traditional parallel cluster…”
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Not in my AI: Moral engagement and disengagement in health care AI development by Nichol, Ariadne A, Halley, Meghan C, Federico, Carole A, Cho, Mildred K, Sankar, Pamela L

“…Machine learning predictive analytics (MLPA) are utilized increasingly in health care, but can pose harms to patients, clinicians, health systems, and the…”
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Health utilities and psychometric quality of life in patients with early- and late-stage hepatitis C virus infection by Hsu, Priscilla C, Federico, Carole A, Krajden, Mel, Yoshida, Eric M, Bremner, Karen E, Anderson, Frank H, Weiss, Alan A, Krahn, Murray D

“…Background and Aim:  Hepatitis C virus (HCV) infection is associated with impairment in health‐related quality of life (HRQOL). The purpose of this study was…”
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Untapped ethical resources for neurodegeneration research by Robillard, Julie M, Federico, Carole A, Tairyan, Kate, Ivinson, Adrian J, Illes, Judy

“…The research community has a mandate to discover effective treatments for neurodegenerative disorders. The ethics landscape surrounding this mandate is in a…”
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Patient time costs and out-of-pocket costs in hepatitis C by Federico, Carole A., Hsu, Priscilla C., Krajden, Mel, Yoshida, Eric M., Bremner, Karen E., Weiss, Alan A., Anderson, Frank H., Krahn, Murray D.

“…Background Hepatitis C virus (HCV) infection is associated with substantial costs to patients, their caregivers and society. Aims We evaluated time costs (time…”
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Consider drug efficacy before first-in-human trials by Kimmelman, Jonathan, Federico, Carole

“…Ethical review boards must focus on clinical promise as well as safety to hold the first tests of drugs in humans to a higher standard, say Jonathan Kimmelman…”
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Reducing barriers to ethics in neuroscience by Illes, Judy, Tairyan, Kate, Federico, Carole A, Tabet, Aline, Glover, Gary H

“…Ethics is a growing interest for neuroscientists, but rather than signifying a commitment to the protection of human subjects, care of animals, and public…”
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Preclinical efficacy in therapeutic area guidelines from the U.S. Food and Drug Administration and the European Medicines Agency: a cross‐sectional study by Langhof, Holger, Chin, William Wei Lim, Wieschowski, Susanne, Federico, Carole, Kimmelman, Jonathan, Strech, Daniel

“…Background and Purpose Therapeutic area guidelines (TAGs) published by the EMA and the FDA offer guidance in planning the launch of a trial in a certain…”
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Moral Engagement and Disengagement in Health Care AI Development by Nichol, Ariadne A., Halley, Meghan, Federico, Carole, Cho, Mildred K., Sankar, Pamela L.

“…Machine learning (ML) is utilized increasingly in health care, and can pose harms to patients, clinicians, health systems, and the public. In response,…”
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