Oncology Clinical Trial
An Oncology Clinical Trial is a quality-of-life clinical trial that focuses on some cancer disease.
- Example(s):
- an Skin Cancer Clinical Trial, which likely involves image recognition.
- …
- Counter-Example(s):
- See: Oncology.
References
2020
- https://www.pharmasug.org/proceedings/2011/IB/PharmaSUG-2011-IB03.pdf
- QUOTE: ... Oncology is somewhat more complicated than other therapeutic areas. The endpoints, for one, differ greatly. For example, rather than running a clinical trial to test the safety and efficacy of an antibiotic against an infection, an oncology trial is trying to extend and improve a subject’s quality of life.
One of the main differentiators is the role of comparator drugs in oncology trials. Placebos are never used in place of treatment when an existing standard therapy exists. If a patient is given a placebo in an oncology trial, it is always in conjunction with other approved treatments. In other therapeutic areas, it is common to have a placebo arm compared to the drug being studied.
Another difference is how adverse events are reported. In non-oncology trials, adverse events are scored as mild, moderate or severe. In oncology, they are given numeric grades with guidelines provided by the National Cancer Institute: Common Terminology Criteria for Adverse Events (CTCAE). In some cases, a grade of 1 corresponds to mild, 2 to moderate, and 3 to severe. There are also two additional grades that may be assigned; 4 is a life-threatening or disabling adverse event, and 5 is a death related to the adverse event. Not all adverse events will allow all five grades. ...
- QUOTE: ... Oncology is somewhat more complicated than other therapeutic areas. The endpoints, for one, differ greatly. For example, rather than running a clinical trial to test the safety and efficacy of an antibiotic against an infection, an oncology trial is trying to extend and improve a subject’s quality of life.