Pro tip: Given the maturity of data about trial drugs in later Phases, do review and discuss with your Oncologists about high-value Clinical Trials starting from Phase 3 and then working your way through Phase 2 and Phase 1 trials if necessary.
New Drugs and Treatments are first tested in the Laboratory. When they are found to be safe and effective, they are then tested in Human Clinical Trials.
Human Clinical Trials are generally divided into 3 Phases:
This is the first time the new Drug is tested in humans. There are two main reasons for conducting the Phase I Clinical Trial. First, to find the right dose that is effective in human beings. Second, to test whether the new Drug or Treatment is safe for human use. Phase I is conducted in a small number of human volunteers, to minimize the risk of exposure to patients.
The new Cancer Treatment is then tested for its Effectiveness [in treating or controlling a particular Cancer]. This Phase is conducted in a slightly larger number of human volunteers as compared to Phase I.
The new Cancer Treatment is then further tested for more details of its Effectiveness and Safety. Typically, this Phase III happens on a larger patient population (hundreds to thousands) and can involve comparison with an already established Cancer Treatment (called the current Standard of Care).
There is an additional PHASE IV, which is also called a Post-Marketing Study; in which the Cancer Treatment is tested in the open market for additional information, after the Regulatory Approval.
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