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The World Health Organization published the first tumour response criteria in 1981. However the specification documents were unclear which led to criteria adjustments and inconsistent conclusions. In the mid-1990s, an International Working Party was created to simplify and standardize response criteria; it then published RECIST in 2000.
The immune-related response criteria (irRC) is a set of published rules that define when tumors in cancer patients improve ("respond"), stay the same ("stabilize"), or worsen ("progress") during treatment, where the compound being evaluated is an immuno-oncology drug.
PET response criteria in solid tumors (PERCIST) is a set of rules that define when tumors in cancer patients improve ("respond"), stay the same ("stabilize"), or worsen ("progress") during treatment, using positron emission tomography (PET). The criteria were published in May 2009 in the Journal of Nuclear Medicine (JNM). [1]
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.
In 1965, the English statistician Sir Austin Bradford Hill proposed a set of nine criteria to provide epidemiologic evidence of a causal relationship between a presumed cause and an observed effect. (For example, he demonstrated the connection between cigarette smoking and lung cancer.) The list of the criteria is as follows: [1]
The Common Terminology Criteria for Adverse Events (CTCAE), [1] formerly called the Common Toxicity Criteria (CTC or NCI-CTC), are a set of criteria for the standardized classification of adverse events of drugs and treatment used in cancer therapy. The CTCAE system is a product of the US National Cancer Institute (NCI).
PICOT criteria [7] tend to be used to frame questions used in evidence-based studies, such as medical studies. Such research may focus on assessment or evaluation of patients or problems, as well as what may be the causal factor(s) with control and experimental groups. [citation needed] P – Patient (or Problem) I – Intervention (or Indicator)
Center for Biologics Evaluation and Research – responsible for review and approval of biologic products, including vaccines, blood products, gene therapy and human cloning; Center for Devices and Radiological Health – responsible for review and approval of medical devices and safety of non-medical equipment that emit certain types of radiation