Overview of Clinical Trials


Shirley Mertz, MA, JD, provides an overview of clinical trials and how they are conducted.

These are the experiences and opinions of panelists, not physicians.

Shirley A. Mertz, MA, JD: As we move forward with the Cure Connections Series, let’s recall that in the last segment we learned that Black and Hispanic women are often reluctant to join clinical trials because of past unethical actions towards People of Color by the scientific community, causing mistrust. We also heard that Women of Color are not always invited to participate in Clinical Trials because of preconceived notions by some, but not all, physicians. Now we’re going to discuss the importance of metastatic breast cancer patients understanding how clinical trials are conducted in order to better treat or further understand Metastatic Breast Cancer. Clinical treatment trials are carefully designed research studies that compare the most effective known treatment for a specific type and stage of cancer with a new approach, a new drug, or a combination of drugs. Trials can be sponsored by a pharmaceutical corporation, an academic medical center, or by the National Cancer Institute. Clinical trials are important because they, advance the standard of care treatment for metastatic breast cancer, they increase understanding of the disease process, they are required by the Federal Drug Administration often known as the FDA to gain approval for a new drug treatment, and finally, they provide on-going safety data about a drug. To emphasize, each drug that you and I take as metastatic breast cancer patients began in a laboratory, where scientists conducted research on a new untested drug. That testing can be done in cell lines and/or in animals and are known as pre-clinical trials. If the results look good, then the new drug will be tested in humans. There are four phases of a clinical trial. Simply put, Phase 1 trial test to see if the drug is safe to use. Phase 2 tests to see if the drug works. Phase 3 tests to see how well the drug works compared to the standard of care. If the results of Phase 3 trials indicate that the new drug is performing the same as or superior to standard treatment, the trial sponsor will submit all of the new drug’s data to the FDA for approval so that physicians can prescribe it in the clinic. The final phase of clinical trials is Phase 4 which records ongoing safety data experienced by patients as they use the new drug in the real world setting after it has been approved by the FDA.

This transcript has been edited for clarity.

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