Pragmatica-Lung

NCI’s Doroshow: “These recommendations are something that we can implement right away”

NCI will immediately start the process of streamlining IND-exempt trials in order to make them faster, simpler, more flexible, less expensive, and easier to integrate with clinical practice, James Doroshow, NCI deputy director for clinical and translational research and director of the Division of Cancer Treatment and Diagnosis, said to The Cancer Letter. On Nov....

November 11, 2022

Vol.48 No.41

By Paul Goldberg

Clinical

A brief report sets forth a “new normal,” lets NCI start to streamline clinical trials

The NCI Clinical Trials and Translational Research Advisory Committee has approved an interim set of guidelines for streamlining requirements for conduct of clinical trials.

November 11, 2022

Vol.48 No.41

By Paul Goldberg

Conversation with The Cancer Letter

Ellen Sigal: Pragmatica-Lung may be a model for other trials that are unnecessarily complex

The Pragmatica-Lung trial required many people to start to think differently about conducting phase III clinical trials—and it took a lot of advocacy to make the trial launch quickly, said Ellen Sigal, founder and chair of Friends of Cancer Research.

December 02, 2022

Vol.48 No.43

By Matthew Bin Han Ong

Conversation with The Cancer Letter

Roy Herbst: I hope Pragmatica-Lung will become the norm

Pragmatica-Lung is the first of what is likely to be a series of simpler trials with relaxed enrollment criteria and streamlined data collection requirements.

December 02, 2022

Vol.48 No.43

By Jacquelyn Cobb and Paul Goldberg

Clinical

FDA, NCI align to simplify clinical research, producing a model “pragmatic” registration trial in NSCLC

Pragmatica-Lung is shaping up as the clinical trial to watch—not just because of the research question, but because of the way it’s being addressed.

December 02, 2022

Vol.48 No.43

By Jacquelyn Cobb, Matthew Bin Han Ong and Paul Goldberg

Conversation with The Cancer Letter

FDA’s Singh and Rivera describe the “new normal”—and the future—in cancer pragmatic trials

The past six weeks have brought fundamental change in the way oncology drugs are being developed. At this unprecedented moment in oncopolitics, FDA, NCI, academic oncologists, advocates, and the industry are in agreement on how cancer therapies should be developed, tested and approved.

December 09, 2022

Vol.48 No.44

By Jacquelyn Cobb, Matthew Bin Han Ong and Paul Goldberg

Guest Editorial

S2302 Pragmatica-Lung Trial: Reaching more representative groups of patients with exciting clinical trials

S2302 Pragmatica-Lung is a federally-funded, streamlined clinical trial examining a new combination of agents in patients with advanced non-small cell lung cancer (NSCLC). Like most studies, it is focused on improving outcomes for patients with cancer—but it is also poised to simplify and transform the entire clinical trials model as we know it.

December 21, 2022

Vol.48 No.46

By Jhanelle E. Gray, Karen Reckamp, Mary Redman, Konstantin H. Dragnev, Ellen V. Sigal, Shakun Malik, Meg Mooney, James H. Doroshow and Charles D. Blanke

Clinical

Pragmatica-Lung, a landmark pragmatic trial with registrational intent, starts enrollment

Pragmatica-Lung, the first study born from a broader effort by NCI, FDA, industry, academia, and advocacy groups to modernize the clinical trial process, has begun enrolling patients.

April 14, 2023

Vol.49 No.15

By Jacquelyn Cobb

NCI’s Doroshow: “These recommendations are something that we can implement right away”

A brief report sets forth a “new normal,” lets NCI start to streamline clinical trials

Ellen Sigal: Pragmatica-Lung may be a model for other trials that are unnecessarily complex

Roy Herbst: I hope Pragmatica-Lung will become the norm

FDA, NCI align to simplify clinical research, producing a model “pragmatic” registration trial in NSCLC

FDA’s Singh and Rivera describe the “new normal”—and the future—in cancer pragmatic trials

S2302 Pragmatica-Lung Trial: Reaching more representative groups of patients with exciting clinical trials

Pragmatica-Lung, a landmark pragmatic trial with registrational intent, starts enrollment

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