How Breast Cancer Clinical Trials Work

How Breast Cancer Clinical Trials Work
Developing a new medical treatment for breast cancer takes many years. The process is intended to best improve the treatment of diseases and medical conditions without harming people. Here you can read about how new therapies are developed, tested in clinical trials, and eventually made available to patients with a wide range of diseases, including breast cancer.

Basic Research, R&D

Before clinical trials can begin, there needs to be evidence that a treatment is effective. Sometimes this evidence comes from academic labs that largely explore science for its own sake, not necessarily for the development of a drug. This is called “basic research.” From ideas generated in basic research or from company-sponsored “research and development" or (R&D), experiments typically proceed to pre-clinical research.

Pre-clinical Research

Pre-clinical testing is necessary before a medication or treatment proceeds to clinical trials. This testing involves experiments with animals, and also with cells in a dish (in vitro testing). While still necessary to advance potential therapies for diseases such as breast cancer, modern-day animal testing is generally governed by three principals: 1) reduce the use of animals to a minimum but utilize animal test subjects to collect data indicating that a treatment is safe and effective in people, 2) minimize animal suffering and assure animal welfare as much as possible, and 3) replace animal experiments with other alternatives when possible. A great deal of pre-clinical testing focuses on ensuring that a treatment is safe, for example, that the treatment does not cause birth defects (teratology) or other medical problems. Pre-clinical testing can also focus on how a treatment works and whether it
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