Each year medical researchers develop new cancer treatments, or find new ways to use existing treatments. The goals of cancer therapy, in order of importance are: 1) highly effective, hopefully curative therapy, 2) infrequent side effects and minimal toxicity to normal body functions, 3) patient convenience and affordable treatment.
Clinical trials are the pathways to develop and evaluate more effective and less toxic therapies. New treatments are tested in a series of trials known as Phase I, Phase II and Phase III trials. New cancer therapeutic agents are evaluated and approved by the US Federal Drug Administration (FDA) only after the Phase III clinical trials have demonstrated evidence of superior outcomes or less toxicity when compared to standard treatments. Similarly, new surgical approaches are uniformly recommended and adopted after Phase III trials demonstrate superior safety, tolerability and/or effectiveness.
Drug studies can begin in humans only after the FDA and a local institutional review boards (IRB) have given approval. The IRB is a panel of scientists and non-scientists in hospitals and research institutions that oversees clinical research. One of the responsibilities of the board is to ensure that clinical trial participants have given consent and are fully informed of their risks, and that researchers take appropriate steps to protect patients from harm.
Prior to a drug even entering Phase I trials, it is well studied to learn about how best to prepare, store and administer the drug. Preclinical testing is usually conducted in animals and human cell cultures.
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