Richard Pazdur likely did not surprise anyone when he complained to Friends of Cancer Research Annual Meeting attendees that oncology clinical trials are too complicated. But the director of the US Food and Drug Administration’s Oncology Center of Excellence got a few laughs when he announced his solution.
Project Pragmatica: US FDA’s OCE Initiative Aims To Encourage Simple Clinical Trials
OCE Director Richard Pazdur says idea for the latest initiative stemmed from a clinical trial in lung cancer that he thought only needed to measure the impact on overall survival.

More from Clinical Trials
Newly published insights from a series of European Medicines Agency workshops can guide drug developers in designing development plans that meet the needs of both regulators and health technology assessment bodies.
The new global GCP guideline, ICH E6(R3), enables researchers and clinical trial administrators to tailor their documentation processes, but also opens the door for more scrutiny during GCP inspections.
The European Medicines Agency’s qualification of the AIM-NASH tool is said to signify a major advancement for clinical trials for metabolic dysfunction-associated steatohepatitis. The market size for MASH treatments is expected to grow substantially in the coming years.
As Indian CROs are bracing for new registration mandates, an expert panel at the IGBA’s 3rd Bioequivalence conference discusses the implications of non-compliance in bioequivalence studies.
More from R&D
As Indian CROs are bracing for new registration mandates, an expert panel at the IGBA’s 3rd Bioequivalence conference discusses the implications of non-compliance in bioequivalence studies.
Experts working in the advanced therapy space say the US has less strict criteria for regulatory pathways for cell and gene therapies than the EU, particularly for products in early development.
Japan adds four new pediatric vaccines, including for MMRV and norovirus, to a list of priority vaccines eligible for assistance in regulatory processing.