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The search for clarity regarding “clinically meaningful outcomes” in Alzheimer disease clinical trials: CLARITY-AD and Beyond
CLARITY-AD is an 18-month, double-blinded, placebo-controlled, phase 3 trial which examined the safety and efficacy of the anti-amyloid agent,...
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Consensus Recommendations for Clinical Outcome Assessments and Registry Development in Ataxias: Ataxia Global Initiative (AGI) Working Group Expert Guidance
To accelerate and facilitate clinical trials, the Ataxia Global Initiative (AGI) was established as a worldwide research platform for trial readiness...
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Common Clinical Trial Designs
Clinical Trials are studies conducted for the purpose of assessing the effect of an intervention in a defined population, or to evaluate one or more...
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Quality by Design in Relation to Clinical Trials
Clinical trials play a crucial role in evaluating the safety and efficacy of new drugs and treatments. Ensuring the quality and integrity of clinical...
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Progression analysis versus traditional methods to quantify slowing of disease progression in Alzheimer’s disease
BackgroundThe clinical meaningfulness of the effects of recently approved disease-modifying treatments (DMT) in Alzheimer’s disease is under debate....
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Stakeholder Engagement in Predictive Model Development for Clinical Decision Support
This chapter describes a study to develop a practical tool to help patients and their clinicians choose which type of knee osteoarthritis treatment...
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Meaningful benefits: a framework to assess disease-modifying therapies in preclinical and early Alzheimer’s disease
BackgroundThe need for preventive therapies that interrupt the progression of Alzheimer’s disease (AD) before the onset of symptoms or when symptoms...
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Developmental associations between cognition and adaptive behavior in intellectual and developmental disability
BackgroundIntellectual and developmental disabilities (IDDs) are associated with both cognitive challenges and difficulties in conceptual, social,...
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Implementation of Mobile Health Technologies in Clinical Trials of Movement Disorders: Underutilized Potential
Mobile health technologies (mHealth) are patient-worn or portable devices aimed at increasing the granularity and relevance of clinical measurements....
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Multicentric investigation on the safety, feasibility and usability of the ABLE lower-limb robotic exoskeleton for individuals with spinal cord injury: a framework towards the standardisation of clinical evaluations
BackgroundRobotic lower-limb exoskeletons have the potential to provide additional clinical benefits for persons with spinal cord injury (SCI)....
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Great Expectations: recommendations for improving the methodological rigor of psychedelic clinical trials
RationalePsychedelic research continues to garner significant public and scientific interest with a growing number of clinical studies examining a...
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Minimally important differences for the EORTC QLQ-C30 in prostate cancer clinical trials
BackgroundThe aim of the study was to estimate the minimally important difference (MID) for interpreting group-level change over time, both within a...
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Development of an adapted Clinical Global Impression scale for use in Angelman syndrome
BackgroundThe Clinical Global Impression-Severity (CGI-S) and CGI-Improvement (CGI-I) scales are widely accepted tools that measure overall disease...
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The experiences of people with incomplete spinal cord injury or disease during intensive balance training and the impact of the program: A qualitative study
Study designQualitative descriptive study.
ObjectivesTo gain insight into if and how participation in intensive balance training impacted the daily...
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Quantitative Gait and Balance Outcomes for Ataxia Trials: Consensus Recommendations by the Ataxia Global Initiative Working Group on Digital-Motor Biomarkers
With disease-modifying drugs on the horizon for degenerative ataxias, ecologically valid, finely granulated, digital health measures are highly...
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Partial recovery of peripheral blood monocyte subsets in head and neck squamous cell carcinoma patients upon radio(chemo)therapy is associated with decreased plasma CXCL11
BackgroundHead and neck squamous cell carcinoma (HNSCC) represents a common and heterogeneous malignancy of the oral cavity, pharynx and larynx....
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Content Validity of the Modified Functional Scale for the Assessment and Rating of Ataxia (f-SARA) Instrument in Spinocerebellar Ataxia
The functional Scale for the Assessment and Rating of Ataxia (f-SARA) assesses Gait, Stance, Sitting, and Speech. It was developed as a potentially...
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Impact of potential modifications to Alzheimer’s disease clinical trials in response to disruption by COVID-19: a simulation study
BackgroundThe COVID-19 pandemic disrupted Alzheimer disease randomized clinical trials (RCTs), forcing investigators to make changes in the conduct...
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Acupuncture versus cognitive behavioral therapy for pain among cancer survivors with insomnia: an exploratory analysis of a randomized clinical trial
Pain and insomnia often co-occur and impair the quality of life in cancer survivors. This study evaluated the effect of acupuncture versus cognitive...
