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2. Clinical endpoint - Wikipedia

   en.wikipedia.org/wiki/Clinical_endpoint

   Overall Treatment Utility is an example of a multidimensional composite endpoint in cancer clinical trials. [8] Regarding humane endpoints, a combined endpoint may constitute a threshold where there is enough cumulative degree of disease, symptoms, signs or laboratory abnormalities to motivate an intervention. [citation needed]

3. Progression-free survival - Wikipedia

   en.wikipedia.org/wiki/Progression-free_survival

   Progression-free survival (PFS) is "the length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse". [1] In oncology, PFS usually refers to situations in which a tumor is present, as demonstrated by laboratory testing, radiologic testing, or clinically. Similarly ...

4. Accelerated approval (FDA) - Wikipedia

   en.wikipedia.org/wiki/Accelerated_approval_(FDA)

   Surrogate endpoints typically require less time, and in the case of a cancer patient, it is much faster to measure a reduction in tumor size, for example, than overall patient survival. Drugs approved under the FDA Accelerated Approval Program still need to be tested in clinical trials using endpoints that demonstrate clinical benefit, and ...

5. Response evaluation criteria in solid tumors - Wikipedia

   en.wikipedia.org/wiki/Response_Evaluation...

   This distinction must be made by both the treating physicians and the cancer patients themselves. Many oncologists in their daily clinical practice follow their patients' malignant disease by means of repeated imaging studies and make decisions about continuing therapy on the basis of both objective and symptomatic criteria.

6. Surrogate endpoint - Wikipedia

   en.wikipedia.org/wiki/Surrogate_endpoint

   In clinical trials, a surrogate endpoint (or surrogate marker) is a measure of effect of a specific treatment that may correlate with a real clinical endpoint but does not necessarily have a guaranteed relationship. The National Institutes of Health (USA) defines surrogate endpoint as "a biomarker intended to substitute for a clinical endpoint ...

7. List of Guidances for Statistics in Regulatory Affairs

   en.wikipedia.org/wiki/List_of_Guidances_for...

   FDA: Clinical trial endpoints for the approval of cancer drugs and biologics [17] provides recommendations to applicants on endpoints for cancer clinical trials submitted to the Food and Drug Administration (FDA) to support effectiveness claims in new drug applications (NDAs), biologics license applications (BLAs), or supplemental applications.