> ## 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.

# OCE Working to Simplify Cancer Trials
- URL: https://www.fdaweb.com/oce-working-to-simplify-cancer-trials/
- Published: 2024-01-04T12:00:00.000Z
- Updated: 2026-09-14T14:19:34.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156081

The FDA Oncology Center of Excellence (OCE) is taking steps to encourage simplification of cancer clinical trials. Writing in a *Comment* in *Lancet Oncology*,researchers with the CDER Office of Oncologic Diseases and OCE [say](https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045%2823%2900627-7/fulltext?ref=fdaweb.com) they want “the oncology drug development community to work to find opportunities to bring simplicity back to clinical trials, because when there is a focused question, less could be more.”

The researchers say OCE’s Project Pragmatica, named for a simplified lung cancer study, “will bring together patients, trial investigators, and pharmaceutical companies to evaluate opportunities to incorporate pragmatic elements into multiregional cancer clinical trials.”

They write that traditional clinical trials are often done in highly controlled settings and involve strict eligibility criteria that can limit the generalizability of their findings. In contrast, they say, a more pragmatic clinical trial can be designed to reflect the inherent variability in clinical practice and include a broader range of patients, interventions, and outcomes. Pragmatic clinical trial elements also integrate functional efficiencies, such as fewer and simpler eligibility criteria and flexibilities in trial delivery and outcome measurement that can reduce the burden to both patients and investigators, the comment says.

The authors conclude that oncology is an active area of drug development that could benefit from reducing the complexity of randomized trials where appropriate. “We believe that all prospective oncology clinical trials should be carefully reviewed to identify trial elements that could be made more pragmatic,” they say.