What Are Master Protocols?
Master protocols are clinical trials that are specifically designed to allow researchers to study several molecular markers and targeted therapies simultaneously. These protocols also allow researchers to introduce new therapies into a trial that is already underway.
Researchers are still learning the best way to design these protocols and choose the proper statistical methods for evaluating their findings. Here you can read about how master protocols are being used in breast cancer and other clinical trials.
- FDA Video: What Are Master Protocols?
- FDA Draft Guidance: Master Protocols
- Contemporary Clinical Trials Communications: Master protocol trials in oncology: Review and new trial designs
- Cancer Biology & Medicine: A New Generation of Breast Cancer Clinical Trials