Here is the first part of an article titled, Trial aims to shave years off cancer drug development by GREG FREIHERR, which appeared May 13, 2010 on Cancer

The regimented and inflexible protocols that have long served as the hallmarks of clinical trials are giving way to a personalized research design that could dramatically reduce the time and expense of developing cancer drugs. A new trial dubbed I-SPY 2 (Investigation of Serial Studies to Predict Your Therapeutic Response with Imaging and Molecular Analysis) has set an ambitious goal: To change the way clinical trials are conducted.

“We are not testing, stopping, waiting two or three years, and then writing another protocol. Those days are over,” said Laura J. Esserman, MD, MBA, I-SPY 2 co-principal investigator and director of the Carol Franc Buck Breast Care Center at the University of California, San Francisco.

Specifically, I-SPY 2 will run continuously, with stages II and III breast cancer patients first being stratified into subgroups based on biomarkers and genetic testing. Then, rather than blasting all patients with a single experimental drug, patients will be randomized to receive standard neoadjuvant chemotherapy alone or paired with an experimental agent, selected according to the molecular signature of the patient’s tumor, said Donald A. Berry, PhD, co-principal investigator and head of the division of quantitative sciences at Houston’s M.D. Anderson Cancer Center.

“This trial is a model for innovation in drug development.”
When a drug combination proves effective against a certain subtype of cancer, that experimental arm will “graduate” into a larger trial. If the combination continues to be successful, it will proceed into a relatively small, focused phase III trial and, ultimately, routine medical practice.

The article is much too long to reproduce here in its entirety. Go to The I-SPY 2 breast cancer trial to read the rest. Sounds like this stream-lined clinical trial model has potential. Anything which speeds up the process works for me!

Feel good and keep smiling! Pat

Leave a Reply