The term 'futility' is used to refer to the inability of a clinical trial to achieve its objectives. In particular, stopping a clinical trial when the interim results suggest that it is unlikely to achieve statistical significance can save resources that could be used on more promising research. There are various approaches that have been proposed to assess futility, including stochastic curtailment, predictive power, predictive probability, and group sequential methods. In this paper, we describe and contrast these approaches, and discuss several issues associated with futility analyses, such as ethical considerations, whether or not type I error can or should be reclaimed, one-sided vs two-sided futility rules, and the impact of futility analyses on power.
Download full-text PDF |
Source |
---|---|
http://dx.doi.org/10.1002/pst.216 | DOI Listing |
Viruses
December 2024
Pharmalex India Pvt. Ltd., Noida 201301, India.
Nasal spray treatments that inhibit the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) entry into nose and nasopharynx at early stages can be an appropriate approach to stop or delay the progression of the disease. We performed a prospective, randomized, double-blind, placebo-controlled, parallel-group, multicentric, phase II clinical trial comparing the rate of hospitalization due to COVID-19 infection between azelastine 0.1% nasal spray and placebo nasal spray treatment groups.
View Article and Find Full Text PDFVaccines (Basel)
November 2024
Vaccine Research and Development, Pfizer Inc., Pearl River, NY 10965, USA.
Background/objectives: Respiratory syncytial virus (RSV) is the leading cause of severe respiratory disease in infants worldwide. Maternal immunization to protect younger infants is supported by evidence that virus-neutralizing antibodies, which are efficiently transferred across the placenta from mother to fetus, are a primary immune mediator of protection. In maternal RSV vaccine studies, estimates of correlates of protection are elusive because many factors of maternal-fetal immunobiology and disease characteristics must be considered for the estimates.
View Article and Find Full Text PDFSensors (Basel)
December 2024
Department of Nursing, Physiotherapy and Medicine, University of Almería, La Cañada de San Urbano, 04120 Almería, Spain.
Background: Non-specific chronic neck pain is a prevalent musculoskeletal disorder with a significant impact on individuals' quality of life. The lack of consensus on effective therapeutic management complicates the establishment of standardized treatment protocols. Home exercise programs have yielded positive results.
View Article and Find Full Text PDFNutrients
December 2024
Department of Clinical Medicine, Aarhus University Hospital, Aarhus University, Palle Juul-Jensens Boulevard 165, 8200 Aarhus, Denmark.
Background: This study aimed to compare the effects of a carbohydrate (CHO) hydrogel with (ALG-CP) or without (ALG-C) branched-chain amino acids, and a CHO-only non-hydrogel (CON), on cycling performance. The hydrogels, encapsulated in an alginate matrix, are designed to control CHO release, potentially optimising absorption, increasing substrate utilisation, and reducing gastrointestinal distress as well as carious lesions.
Methods: In a randomised, double-blinded, crossover trial, 10 trained male cyclists/triathletes completed three experimental days separated by ~6 days.
Nutrients
December 2024
Exerkine Corporation, McMaster University Medical Center, Hamilton, ON L8N 3Z5, Canada.
Background: Anabolic resistance accelerates muscle loss in aging and obesity, thus predisposing to sarcopenic obesity.
Methods: In this retrospective analysis of a randomized clinical trial, we examined baseline predictors of the adaptive response to three months of home-based resistance exercise, daily physical activity, and protein-based, multi-ingredient supplementation (MIS) in a cohort of free-living, older males ( = 32).
Results: Multiple linear regression analyses revealed that obesity and a Global Risk Index for metabolic syndrome (MetS) were the strongest predictors of Δ% gains in lean mass (TLM and ASM), LM/body fat ratios (TLM/%BF, ASM/FM, and ASM/%BF), and allometric LM (ASMI, TLM/BW, TLM/BMI, ASM/BW), with moderately strong, negative correlations to the adaptive response to polytherapy r = -0.
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!