> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# FDA Mulls New Clinical Trial Eligibility Criteria: Pazdur
- URL: https://www.fdaweb.com/fda-mulls-new-clinical-trial-eligibility-criteria-pazdur/
- Published: 2016-09-16T12:00:00.000Z
- Updated: 2026-09-14T21:32:38.000Z
- Author: David McFarland
- Tags: Drugs, Devices, #legacy-id-D5136829

FDA is working with stakeholders to revisit criteria used for determining whether a patient is eligible to participate in a trial, according to Oncology Center of Excellence (OCE) acting director **Richard Pazdur** in a new [blog posting](http://blogs.fda.gov/fdavoice/index.php/2016/09/evaluating-fdas-approach-to-cancer-clinical-trials/?source=govdelivery&utm%5Fmedium=email&utm%5Fsource=govdelivery). “Modifying the eligibility criteria could expand the number of people who qualify and therefore open new opportunities for participation and enhance the generalizability of what we learn,” he says.

This is Pazdur’s first open communication since being selected to head OCE two months ago. The Center is being created to leverage the combined skills of oncologists and scientists with expertise in drugs, biologics, and devices to employ the best and most innovative approaches to bring forth safe new oncology products.

“We recently published our [perspective](http://www.nejm.org/doi/full/10.1056/NEJMp1603747?ref=fdaweb.com#t=article) on shifting away from the conventional phase one, phase two, and phase three drug development paradigm to a more seamless approach that could expedite the regulatory pathway, providing earlier access to highly effective therapeutic drugs,” he says. “Adopting this approach could complement FDA’s expedited regulatory programs such as breakthrough designation and accelerated approval to get products to patients in the most efficient manner possible.”

Another initiative, according to Pazdur, is the use of common control trials. “These trials, sharing a common control arm, involve multiple different drugs for the same indication and may involve different companies,” he writes. “When a common control arm is used, it decreases the overall number of patients that need to be recruited and enrolled, optimizing clinical trial resources and potentially decreasing the time it takes to get a new study off the ground.”

Pazdur says collaboration is key to achieving success at the Center. [Several public meetings](http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/ucm509057.htm?ref=fdaweb.com) are being scheduled that will provide a forum to interact with patients and other stakeholders, he adds.