> ## 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.

# Pazdur Explains New Cancer Trial Guidance
- URL: https://www.fdaweb.com/pazdur-explains-new-cancer-trial-guidance/
- Published: 2018-08-14T12:00:00.000Z
- Updated: 2026-09-15T00:25:31.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5142106

FDA Oncology Center of Excellence director **Richard Pazdur** says a draft guidance, *Use of Expansion Cohorts in First-in-Human Clinical Trials to Expedite Development of Cancer Drugs and Biologics*, published 8/2018, is intended to “help advance effective and innovative clinical trial designs early in drug development to help bring new cancer therapies to patients as quickly as possible.” In an *FDA Voice* blog [post](https://blogs.fda.gov/fdavoice/index.php/2018/08/fda-advances-efficient-approaches-to-designing-and-conducting-cancer-clinical-trials/?utm%5Fcampaign=FDA%20Voice%20FDA%20Advances%20Efficient%20Approaches%20to%20Designing%20and%20Conducting%20Cancer%20Clinical%20Trials&utm%5Fmedium=email&utm%5Fsource=Eloqua), Pazdur summarizes the guidance provisions, saying that “trials with multiple expansion cohorts can be inherently more efficient and expedite early drug development. They can address multiple questions in a single trial that is amended as new objectives are identified, avoiding the time lag and additional resources experienced with the opening of new clinical trials.”

Pazdur says the agency wants stakeholder input to make sure that the final guidance is comprehensive and forward-looking and adapts to rapidly changing research developments and technologies. “Our regulatory work needs to remain as advanced as the many new cancer therapies currently working their way through development,” Pazdur concludes.