Validation of surrogate endpoints in advanced solid tumors

Validation of surrogate endpoints in advanced solid tumors - PubMed

We review current statistical approaches to surrogate-endpoint validation based on meta-analysis in various advanced-tumor settings.

Validation of Surrogate Endpoints in Advanced Solid Tumours

Licensing and reimbursement of anticancer drugs should rely on evidence from patient-relevant endpoints such as overall survival (OS).

VALIDATION OF SURROGATE ENDPOINTS IN ADVANCED SOLID ...

Conclusions: Not in all solid tumors the treatment-level association between PFS or TTP and OS has been investigated. According to IQWiG's framework, only PFS ...

Validation of Surrogate Endpoints in Advanced Solid Tumors

Methods: We review current statistical approaches to surrogate-endpoint validation based on meta-analysis in various advanced-tumour settings. We assessed the ...

validation-of-surrogate-endpoints-in-advanced-solid-tumors ...

Methods: We review current statistical approaches to surrogate-endpoint validation based on meta-analysis in various advanced-tumor settings. We assessed the ...

Validation of Surrogate Endpoints in Advanced Solid Tumors

This is a repository copy of Validation of Surrogate Endpoints in Advanced Solid Tumors: Systematic Review of Statistical Methods, Results, and Implications ...

VALIDATION OF SURROGATE ENDPOINTS IN ADVANCED ...

VALIDATION OF SURROGATE ENDPOINTS IN ADVANCED SOLID TUMORS: SYSTEMATIC REVIEW OF STATISTICAL METHODS, RESULTS, AND IMPLICATIONS FOR POLICY MAKERS. Ciani ...

FDA validation of surrogate endpoints in oncology: 2005–2022

The number of cancer drugs approved based on surrogate endpoints is rising. · The FDA has conducted limited surrogate validation studies since 2002. · Only one ...

Review of meta-analyses evaluating surrogate endpoints for overall ...

Meta-analyses have been widely used for the validation of surrogate endpoints, specifically in oncology. ... endpoints and OS for multiple advanced solid-tumor ...

Frequently asked questions on surrogate endpoints in oncology ...

Surrogacy validation is dynamic i.e. the strength of correlation for the same surrogate changes based not only on the tumor type but also ...

CL3 – Validation of Surrogate Endpoints in Advanced Solid ...

Request PDF | CL3 – Validation of Surrogate Endpoints in Advanced Solid Tumours: Systematic Review of Statistical Methods, Results, and Implications for ...

Evaluating the evidence behind the surrogate measures included in ...

Using breast cancer as an example, we evaluated the underlying evidence for the surrogate endpoints for solid tumors listed in the FDA's Table ...

Validation of progression-free survival (PFS) as surrogate endpoint ...

Validation of progression-free survival (PFS) as surrogate endpoint in randomised trials of immune checkpoint inhibitors in advanced solid cancers · Abstract.

VALIDATION OF SURROGATE ENDPOINTS IN ADVANCED SOLID ...

According to IQWiG's framework, only PFS achieved acceptable evidence of surrogacy in metastatic colorectal and ovarian cancer treated with cytotoxic agents.

Review of Surrogate Endpoint Validation Methodologies and ...

required to validate surrogate endpoints for use in solid tumour HTAs. PRM10 ... METHODS: We searched phase II and phase. III clinical trials of advanced breast ...

validation of surrogate endpoints in advanced solid tumors ... - OUCI

Authors: Oriana Ciani; Sarah Davis; Paul Tappenden; Ruth Garside; Ken Stein; Anna Cantrell; Everardo D. Saad; Marc Buyse; Rod S. Taylor. Abstract.

The Strength of Association Between Surrogate End Points and ...

Accessed May 12, 2015. 33. Ciani O, Davis S, Tappenden P, et al. Validation of surrogate endpoints in advanced solid tumors: systematic ...

Progression-free survival as a surrogate for overall survival in ...

Progression-free survival (PFS) is a surrogate endpoint widely used for overall survival (OS) in oncology. Validation of PFS as a surrogate ...

Table of Surrogate Endpoints That Were the Basis of Drug Approval ...

This surrogate endpoint table includes surrogate endpoints that sponsors have used as primary efficacy clinical trial endpoints for approval of new drug ...

Progression-free survival as surrogate and as true end point

In advanced breast cancer, formal validation of PFS as a surrogate for OS has so far been unsuccessful. In advanced colorectal cancer, in contrast, current ...