SILVER SPRING, Md. -- The Food and Drug Administration (FDA) wants to overhaul the current clinical trial process by giving patients, doctors and researchers clearer access to clinical trial information, according to a new FDA statement released by former FDA Commissioner Dr. Scott Gottleib, current FDA director of the Center for Devices and Radiological Health, Dr. Jeff Shuren, and current chief of staff to the FDA commissioner, Lauren Silvis.
The overhaul would focus on a better review system by the FDA for laboratory developed tests (LDTs). A system of review for LDTs is currently not in place. The FDA is worried that the current system exposes patients to serious risks, unnecessary tests and delays in treatment, and it wants to be as transparent as possible.
“Transparency is a critical component of the FDA’s proposed path forward. It’s remarkable to think that in 2019 we don’t know the full universe of tests that drive our health care decisions and contribute to costs throughout the system,” said the FDA statement.
“All stakeholders should have access to information about test developer offerings, performance, claims, regulatory status and adverse events associated with each test. But patients, especially, should be empowered with information about the tests they’re receiving and accurate information that affects their decisions about their own health.”
Resources will focus on the most high-risk testing but the agency stresses that only around 10 percent will need individual pre-market approval. Such testing is for drugs marketed for at-home use or patients used to a drug.
Another 40-50 percent of LDTs would need to be evaluated for design and test validation. Finally, tests considered “Manual, low-risk, custom, low-volume, rare disease, forensic, and public health surveillance tests” will not need to be tested but must be watched so as not to cause harm to the patients.
