Ovarian cancer clinical trial endpoints

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 ...

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.

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, ...

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

ovarian cancer patients. In addition, blood-based biomarkers can be useful in identifying prognostic factors and in selection of patients and stratification ...

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 ...

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

Invited experts presented research findings and discussed endpoints in trials of drugs for treatment of Stage III and IV ovarian cancer. Results. The panel ...

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

PFS has much to commend it as the best primary endpoint for ovarian cancer clinical trials. PFS allows for faster determination of the primary study outcome and ...

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

[1] Based on these observations they concluded that PFS is not an adequate surrogate endpoint for OS in the initial treatment of ovarian cancer.

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 ...

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, ...

When it comes to cancer trials, what's the (end)point?

“An endpoint is something we measure on every patient on a clinical trial and distill it into a number,” said biostatistician Megan Othus, PhD.

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 ...

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 ...

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 ...

Ovarian Cancer Endpoints Workshop

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

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 ...

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

FDA ovarian cancer clinical trial endpoints workshop: A Society of Gynecologic Oncology White Paper · Keywords · ASJC Scopus subject areas · Access to Document.

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

This guidance provides recommendations to applicants on endpoints for cancer clinical trials submitted to the Food and Drug Administration (FDA)