Clinical trial endpoints in ovarian cancer

Ovarian cancer clinical trial endpoints: Society of Gynecologic ...

Clinical trial endpoints have profound effects on late phase clinical trial design, result interpretation, drug development, and regulatory approval of ...

Ovarian cancer clinical trial endpoints: Society of Gynecologic ...

Endpoint selection in ovarian cancer clinical trials should reflect the impact on disease burden and unique characteristics of the treatment ...

FDA ovarian cancer clinical trial endpoints workshop

The FDA “Ovarian Cancer Clinical Trial Endpoints” workshop brought relevant stakeholders together to critically analyze the current state of the science, ...

Ovarian Cancer Research Program Clinical Trial Translational ...

To meet the intent of the funding opportunity, applications for the FY24 OCRP Clinical Trial. Translational Endpoints Research Award must ...

SGO guidance document for clinical trial designs in ovarian cancer

Alternative clinical trial endpoints should be explored in regulatory strategies this should be its own section as in the instructions. a b s t r a c t.

Intermediate clinical endpoints: A bridge between progression‐free ...

Overall survival is regarded as the most clinically relevant endpoint in trials of ovarian cancer, but it may be confounded by multiple ...

Randomised trials in ovarian cancer: trial design considerations

In ovarian cancer trials the traditional patient specific outcomes of interest often include: proportion responding, quality of life or symptom scores, duration ...

Clinical Trial Endpoints for the Approval of Cancer Drugs and ... - FDA

hormonal drugs for breast cancer and a single arm trial of a drug for ROS1-positive metastatic non-small cell lung cancer have used ORR as an endpoint ...

Dr. Markman on Endpoints in Clinical Trials for Ovarian Cancer

All patients with ovarian cancer should be referred to a genetic counselor, and they should all undergo germline and somatic testing. Having ...

Contemporary phase III clinical trial endpoints in advanced ovarian ...

More recently, studies have identified over 20 agents active against ovarian cancer. Reasonable evidence shows that effective post-progression therapy with ...

Clinical trial endpoints in ovarian cancer: Report of an FDA/ASCO ...

A workshop evaluating potential endpoints in ovarian cancer drug research was held in Bethesda, Maryland, in April 2006. Invited experts presented research ...

Outcomes and endpoints in trials of cancer treatment - The Lancet

Trial endpoints should show clinically meaningful improvements in patient survival or quality of life. Alternative endpoints such as progression-free survival, ...

Individualized Treatments and Clinical Trial Endpoints in Ovarian ...

Bradley Monk, MD, gynecologic oncologist, University of Arizona Cancer Center Phoenix Branch, discusses clinical trial endpoints and individualizing ...

Assessment of Progression-Free Survival as a Surrogate End Point ...

Is Progression-free Survival a Valid Surrogate Endpoint for Overall Survival in Front-line Ovarian Cancer Trials? ... Paoletti et al evaluated the ...

Optimal assessment of response in ovarian cancer

In terms of the performance of these endpoints in clinical trials, objective response, when used to assess the activity of new drugs in phase II trials in ...

PFS as an Endpoint in Ovarian Cancer Clinical Trials

PFS is the most commonly used endpoint for ovarian cancer clinical trials. · PFS is relatively easily measured and can be measured in a timely ...

Ovarian Cancer Endpoints Workshop

The Food and Drug Administration (FDA), hosted the "Ovarian Cancer Endpoints ... ovarian cancer biology and implications for clinical trial design ...

free survival and overall survival in ovarian cancer trials

For clinical trials that have settings with a long PPS duration and/or involve multiple rounds of postprogression therapy, a primary endpoint of ...

Clinical trial endpoints in ovarian cancer: report of an FDA/ASCO ...

Clinical trial endpoints in ovarian cancer: report of an FDA/ASCO/AACR Public Workshop. · Antineoplastic Agents · Biomarkers, Tumor · Biomedical Research · CA-125 ...

FDA ovarian cancer clinical trial endpoints workshop: A Society of ...

Thomas J. Herzog, Gwynn Ison, Ronald D. Alvarez, Sanjeeve Balasubramaniam, Deborah K. Armstrong, Julia Beaver, Annie Ellis, Shenghui Tang, Peg Ford, ...