Seamless designs for clinical trials: A new wave in drug development, explained

Liz Meszaros, MDLinx

San Antonio Breast Cancer Symposium 2017

San Antonio, Texas, United States | December 05-09, 2017


With the movement toward developing more targeted therapies, the FDA has updated its drug development system to include what they have designated as ‘seamless design,’ to circumvent the inherent delays in the traditional drug development process, explained Tatiana Prowell, MD, breast cancer scientific liaison, FDA Oncology Center of Excellence, and assistant professor of oncology, The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University.


The seamless design model is designed to promote and hasten the approval process in targeted potential therapies that are appropriate.

“Drugs that are capable of qualifying for breakthrough therapy designation are the kinds of drugs we would like to see targeted to these programs. The efficiencies there are best utilized with the drugs that have the most promise. And the concerns that we have, potentially, with these models, are mitigated when we have a drug that we think is going to be really effective,” said Dr. Prowell.

“Seamless designs are very efficient. They represent the best kind of clinical trials for drugs that truly have unprecedented levels of efficacy. They increase access to study drugs for patients. They develop the drugs more quickly. They minimize randomization of patients to control arms that are probably going to be inferior. But it has to be [with] appropriately selected drugs for it to make sense,” she said.