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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.
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.
Death from cardiovascular disease is an example of a clinical endpoint, whereas measurements of blood pressure, which is not normally associated with any symptoms, is a surrogate endpoint. Other examples of surrogate endpoints are blood lipoproteins and bone density. [2] Composite measures or combined measures are common in clinical research.
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.
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]
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. [3]
For example, if people who have a more refractory or serious problem tend to drop out of a study at a higher rate, even a completely ineffective treatment may appear to be providing benefits if one merely compares the condition before and after the treatment for only those who finish the study (ignoring those who were enrolled originally, but ...
The primary efficacy endpoint was the overall response rate (ORR) analyzed after 25 weeks of treatment. [2] The clinical trial demonstrated a statistically significant improvement in ORR in subjects who received pexidartinib, with an ORR of 38%, compared to no responses in subjects who received placebo. [2]