Are clinical trials representative of a broader patient population?

Sarah Anwar, MDLinx

San Antonio Breast Cancer Symposium 2017

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


In clinical trials for cancer drug development, researchers have been enrolling patients who are otherwise healthy; patients who are asymptomatic, and have free mobility. By doing this they can “isolate” the cancer to ensure that symptoms and complications are not due to other underlying conditions. 


According to Tatiana Prowell, MD, breast cancer scientific liaison, FDA Oncology Center of Excellence, assistant professor of oncology, the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University, however, the challenge with this, is that, more often than not, everyday cancer patients aren’t generally healthy and asymptomatic.

“There are other groups that I think we’ve excluded in the past, too. So, that would include patients with metastatic involvement of the central nervous system, brain metastases. It would include patients at extremes of age in either directions. Historically, some trials limited patients are over 70 who weren’t able to enroll. Pediatric patients weren’t able to enroll,” said Dr. Prowell.

“This resulted in clinical trials that took longer to accrue [and] gave us results that were less generalizable to the sorts of patients that would be treated.”

However, more recently, there’s been a move to make clinical trials more representative of a wider cancer population.