Pazdur Puts Foot Down on Single Country Trials
FDA Oncology Center of Excellence director Richard Pazdur says the agency wants to see multiregional trials in oncology submissions that represent the major International Conference for Harmonization (ICH) regions in the world. Speaking at the 2022 Friends of Cancer Research (FOCR) in Washington, DC 11/17, Pazdor expanded on a comment piece he coauthored in The Lancet earlier this year that called into question the development of dozens of oncology drug development programs that rely almost exclusively on clinical data from China. At the time, Pazdur and oncology division director Harpreet Singh said there are at least 25 applications from China in drug development phases, planned to be submitted, or currently under review.
“So we want adequate representation of patients from North America, Europe, Asia to be represented,” he told FOCR. “We believe that this gives us a spectrum of a representation of patients from our own country. We’re not suggesting that all clinical trials have to be done in the United States, or that there is a percentage that has to be done in the United States, but we want representation from all of the ICH regions.”
He said drugs being developed in a single country are problematic because the data would not represent the diversity of the U.S. population. “Frequently, we don't have experience with those countries from a regulatory point of view,” he continued. “By having those countries participate in multi-regional trials, we’re actually bringing in those countries to the international regulatory community by doing analyses of different sites and different countries, and we’re able to see if there are different results, different toxicities, different efficacy parameters that one may take a look at. So, it’s in the long-term interest to have multiregional trials being done throughout the world.”
Pazdur said that one of the major issues is determining why a company would choose not to conduct a trial in the U.S. if it is seeking approval for its drug there. “If it’s cost, that might be a reasonable issue,” he explained, adding that he is ethically troubled when he sees trials not conducted in the U.S. because there’s a better therapy that is approved in the U.S and the company has decided to conduct a randomized study against a known inferior therapy in another country. He said people that go into clinical trials should be getting the best therapies.
“I think we are going to have to answer to this if this continues,” Pazdur continued “because people are going to potentially lose confidence in the system if they know that clinical trials are being done and they’re getting inferior treatments… I firmly believe that these companies are not Mother Teresa, so to speak, and that they’re using patients here and we have to always make sure that patients are not considered commodities of drug development.”