A comparison of methods for treatment selection in seamless phase II/III clinical trials incorporating information on short-term endpoints [PDF]
In an adaptive seamless phase II/III clinical trial interim analysis data are used for treatment selection, enabling resources to be focussed on comparison of more effective treatment(s) with a control.
Friede, Tim +4 more
core +1 more source
Interferon β-1a in relapsing multiple sclerosis: four-year extension of the European IFNβ-1a Dose-C omparison Study [PDF]
Background: Multiple sclerosis (MS) is a chronic disease requiring long-term monitoring of treatment. Objective: To assess the four-year clinical efficacy of intramuscular (IM) IFNb-1a in patients with relapsing MS from the European IFNb-1a Dose-C ...
Achiti, J. +98 more
core +1 more source
Assessment of severe malaria in a multicenter, phase III, RTS, S/AS01 malaria candidate vaccine trial: case definition, standardization of data collection and patient care. [PDF]
BACKGROUND\ud \ud An effective malaria vaccine, deployed in conjunction with other malaria interventions, is likely to substantially reduce the malaria burden. Efficacy against severe malaria will be a key driver for decisions on implementation.
Amanda Leach +18 more
core +4 more sources
Chronic urticaria is a chronic skin disease that affects up to 1% of the general population worldwide, with chronic spontaneous urticaria accounting for more than two-thirds of all chronic urticaria cases.
Taig Mac Carthy +8 more
doaj +1 more source
Introduction Prior observational work in a heterogeneous cohort of participants with mild cognitive impairment suggests the Amsterdam Instrumental Activities of Daily Living Questionnaire (A‐IADL‐Q) may have greater sensitivity for functional decline ...
Edmond Teng +7 more
doaj +1 more source
Effect of sacubitril/valsartan on recurrent events in the prospective comparison of ARNI with ACEI to determine impact on global mortality and morbidity in heart failure trial (PARADIGM-HF) [PDF]
Aims: Recurrent hospitalizations are a major part of the disease burden in heart failure (HF), but conventional analyses consider only the first event. We compared the effect of sacubitril/valsartan vs.
Abraham +18 more
core +3 more sources
Background There is growing interest in identifying sensitive composite cognitive tests to serve as primary endpoints in preclinical Alzheimer’s disease (AD) treatment trials.
Jessica B. Langbaum +10 more
doaj +1 more source
RAD50 missense variants differentially affect the DNA damage response and mitotic progression
RAD50 incorporates into the MRN complex and initiates the DNA damage response. Furthermore, RAD50 promotes mitotic progression. RAD50 missense variants capable of forming an MRN complex supported the DNA damage response and mitotic features to different extents in complementation experiments, indicating these functions are separable and might impact ...
Hanna Redeker +9 more
wiley +1 more source
Extension of the asymptotic relative efficiency method to select the primary endpoint in a randomized clinical trial [PDF]
We extend the ARE method proposed in Gómez and Lagakos (2013) devised to decide which primary endpoint to choose when comparing two treatments in a randomized clinical trial.
Gómez Melis, Guadalupe +1 more
core
Randomized trial comparing proactive, high-dose versus reactive, low-dose intravenous iron supplementation in hemodialysis (PIVOTAL) : Study design and baseline data [PDF]
Background: Intravenous (IV) iron supplementation is a standard maintenance treatment for hemodialysis (HD) patients, but the optimum dosing regimen is unknown.
Anker, Stefan D. +12 more
core +4 more sources

