Rick Pazdur, director of the U.S. Food and Drug Administration’s Oncology Center of Excellence and longtime defender of the agency’s accelerated approval program, acknowledged that some changes are likely needed to the process to ensure timely receipt of confirmatory trial data.
Numerous studies have found that in the U.S., minorities such as African Americans, Hispanics and Native Americans are often underrepresented in clinical trials. Regulatory agencies and various organizations are making an effort to address this issue.
A recent study published in JAMA Oncology found that although about a third of cancer clinical trials failed to meet their primary endpoints, at oncology meetings they tend to be spun in a positive light.
Cancer drug study patients tend to be younger than most people with the disease in the general population.
