The decision to terminate a clinical trial earlier than planned is often described as ethically problematic, but it is rarely systematically analyzed as an ethical issue in its own right. This paper provides an overview of the main ethical considerations at stake in such decisions and of the main tensions between these considerations. Arguments about informed consent and the impact of early stopping on research and society are explored. We devote particular attention to a familiar conflict that arises with special urgency when early data suggest that the experimental treatment is superior. Should the trial be stopped so that participants in the control group will not be allocated a seemingly inferior treatment, or should it continue in pursuit of evidence conclusive enough to improve the care of future patients? We scrutinize three ways to address this problem. Rather than dissolving the tension, they represent different trade-offs between the respective welfare interests of subjects and future patients.
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http://dx.doi.org/10.1353/ken.2011.0002 | DOI Listing |
Res Pract Thromb Haemost
January 2025
Department of Cardiovascular Sciences, University of Birmingham, Birmingham, United Kingdom.
Andexanet Alfa in Acute Intracranial Hemorrhage in Patients Receiving an Oral Factor Xa Inhibitor (ANNEXA-I), the first ever randomized controlled trial of a reversal agent for direct oral anticoagulants, was published in 2024. The trial, which randomized patients with intracranial hemorrhage to andexanet alfa or usual care, was mandated by the United States Food and Drug Administration as part of its conditional approval in 2018. This approval was originally based on the single-arm trial, The Andexanet Alfa, a Novel Antidote to the Anticoagulation Effects of Factor Xa Inhibitors (ANNEXA-4).
View Article and Find Full Text PDFFront Neurol
January 2025
Department of Neurology, The General Hospital of Western Theater Command, Chengdu, Sichuan, China.
Autoimmune autonomic ganglionopathy (AAG) is a rare and acquired immune-mediated disease that leads to wide autonomic failure, mainly characterized by orthostatic hypotension, gastrointestinal dysfunction, anhidrosis and poorly reactive pupils. This disorder is usually associated with autoantibodies to the ganglionic nicotinic acetylcholine receptor (gAChR-Ab). In this study, we describe a case of a gAChR-Ab-positive AAG patient with two therapeutic stages.
View Article and Find Full Text PDFAME Case Rep
November 2024
Faculty of Medicine, Imperial College London, London, UK.
Background: Serotonin syndrome is an adverse drug reaction characterised by the excess of serotonin activity in the central nervous system. It is a condition of great concern in primary care where some patients, usually with treatment-resistant depression, get treatment with multiple serotonergic agents.
Case Description: This retrospective case series looked at 20 primary care patients with treatment-resistant depression who developed mild serotonin syndrome after starting a second antidepressant.
Acta Med Indones
October 2024
Division of Tropical and Infection Diseases, Department of Internal Medicine, Medical Faculty of Universitas Sebelas Maret - Moewardi Hospital, Surakarta, Indonesia.
A 71-year-old man complained of a blackish wound under his left eye, which began with fever and reddish spots after helping to slaughter a cow and cut its meat. The fever occured especially in the afternoon to evening, and is not accompanied by chills and sweating. On day 4 of fever onset, the fever diminished and the spots progressively widened with swelling.
View Article and Find Full Text PDFNutrients
January 2025
Department of Obstetrics and Gynaecology, Semmelweis University, Üllői Street 78/a, 1082 Budapest, Hungary.
Background/objectives: Both hyperandrogenism (HA) and vitamin D deficiency (VDD) can separately lead to impaired vascular reactivity and ovulatory dysfunction in fertile females. The aim was to examine the early interactions of these states in a rat model of PCOS.
Methods: Four-week-old adolescent female rats were divided into four groups: vitamin D (VD)-supplemented ( = 12); VD-supplemented and testosterone-treated ( = 12); VDD- ( = 11) and VDD-and-testosterone-treated ( = 11).
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