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An example of a cancer study powered for a combined endpoint is disease-free survival; trial participants experiencing either death or discovery of any recurrence would constitute the endpoint. Overall Treatment Utility is an example of a multidimensional composite endpoint in cancer clinical trials.
An outcome measure, endpoint, effect measure or measure of effect is a measure within medical practice or research, (primarily clinical trials) which is used to assess the effect, both positive and negative, of an intervention or treatment. [1] [2] Measures can often be quantified using effect sizes. [3]
Only patients with measurable disease at baseline should be included in protocols where objective tumor response is the primary endpoint. Measurable disease – the presence of at least one measurable lesion. If the measurable disease is restricted to a solitary lesion, its neoplastic nature should be confirmed by cytology/histology.
Total assessment time for the SCoRS, including scoring, averages 20–30 minutes. The SCoRS requires no additional equipment beyond the paper administration form and is ideally administered in a quiet environment free from distractions. The informant interview can also be administered over the phone if the informant is unable to be physically ...
The clinical global impression – severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Clinicians ask: "Considering your total clinical experience with this particular ...
Ridaforolimus (also known as AP23573 and MK-8669; formerly known as deforolimus [1]) is an investigational targeted and small-molecule inhibitor of the protein mTOR, a protein that acts as a central regulator of protein synthesis, cell proliferation, cell cycle progression and cell survival, integrating signals from proteins, such as PI3K, AKT and PTEN known to be important to malignancy.
Major adverse cardiovascular events (MACE, or major adverse cardiac events) is a composite endpoint frequently used in cardiovascular research. [ 1 ] [ 2 ] Despite widespread use of the term in clinical trials, the definitions of MACE can differ, which makes comparison of similar studies difficult.
A surrogate endpoint of a clinical trial is a laboratory measurement or a physical sign used as a substitute for a clinically meaningful endpoint that measures directly how a patient feels, functions or survives. Changes induced by a therapy on a surrogate endpoint are expected to reflect changes in a clinically meaningful endpoint. [8]