Vice President Joe Biden outlined a plan to improve the efficiency and transparency of the U.S. clinical research system as part of the national cancer moonshot initiative.
The plan includes specific steps to help patients locate trials quickly, incentivize clinical trial design to broaden participation while reducing burden and risk, and strengthen the transparency of trial results.
“These steps will improve the safety, accessibility and impact of our clinical research system,” Biden said in a press release. “They will help patients today and help researchers all over the world in their quests to find new cures. And they come at a true inflection point in our fight against cancer.”
Nearly 31% of open trials listed on clinicaltrials.gov are for cancer-related research. However, 20% of cancer trials are not completed in the United States due to low participation rates. These rates are even lower among patients treated in community settings, as well as among patients who are older or minorities.
As part of the moonshot’s goal to accelerate cancer research, Biden announced the following steps to improve the clinical trial research system:
- The NCI is developing a new application programming interface for the newly launched trials.cancer.gov that will allow researchers and patient groups to tailor information to identify relevant trials;
- The FDA will explore methods for innovative clinical trial designs, such as by modifying the criteria for who can participate in a trial or by sharing control groups across studies using different drugs;
- The Department of Health and Human Services published a final rule that extends the requirement for summary results information reporting on clinicaltrials.gov to include applicable clinical trials of drug products and devices that are not approved, licensed or cleared by the FDA so patients can make more informed decisions about trial participation; and
- The NIH is working to make clinicaltrials.gov more user friendly and accessible.
“Clinical trials are essential for developing new and more effective cancer diagnostics and treatments,” Biden said. “But, right now, less than 5% of cancer patients enroll in a clinical trial, often because patients and doctors don’t know what trials are available. We can do better — and we are.”