Importance Complete information in a trial protocol regarding study outcomes is crucial for
obtaining regulatory approvals, ensuring standardized trial conduct, reducing research …

The promise of adaptation and adaptive designs in implementation science has been
hindered by the lack of clarity and precision in defining what it means to adapt, especially …

Background In patients with heart failure and reduced ejection fraction, sleep-disordered
breathing, comprising obstructive sleep apnoea (OSA) and central sleep apnoea (CSA), is …

Background Early phase dose-finding (EPDF) trials are crucial for the development of a new
intervention and influence whether it should be investigated in further trials. Guidance exists …

Importance The benefit of endovascular stroke therapy (EVT) in large vessel occlusion
(LVO) ischemic stroke is highly time dependent. Process improvements to accelerate in …

The use of real-world data (RWD) for generating real-world evidence (RWE) to complement
interventional clinical trial-based research is rapidly increasing. This evolving field is …

Randomised controlled trials commonly use surrogate endpoints to substitute for a target
outcome (outcome of direct interest and relevance to trial participants, clinicians, and other …

Randomised controlled trials often use surrogate endpoints to substitute for a target outcome
(an outcome of direct interest and relevance to trial participants, clinicians, and other …

Importance Moderate-grade adolescent idiopathic scoliosis (AIS) may be treated with full-
time bracing. For patients who reject full-time bracing, the effects of alternative, conservative …

Background Affective responses are increasingly recognized as potentially effective
intervention targets that may facilitate exercise and physical activity behavior change. While …