(Q33921813)

30 July 2017

title

Surrogate endpoints in oncology: when are they acceptable for regulatory and clinical decisions, and are they currently overused? (English)

1 reference

30 July 2017

Robert Kemp

1

1 reference

30 July 2017

Vinay Prasad

series ordinal

2

1 reference

30 July 2017

language of work or name

English

0 references

publication date

21 July 2017

1 reference

30 July 2017

1 reference

30 July 2017

volume

15

1 reference

30 July 2017

issue

1

1 reference

30 July 2017

page(s)

134

1 reference

Milestone Analyses of Immune Checkpoint Inhibitors, Targeted Therapy, and Conventional Therapy in Metastatic Non-Small Cell Lung Cancer Trials: A Meta-analysis

30 July 2017

cites work

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=5520356

Adjuvant Pertuzumab and Trastuzumab in Early HER2-Positive Breast Cancer

5 July 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=5520356

What constitutes an "unmet medical need" in oncology? An empirical evaluation of author usage in the biomedical literature

5 July 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=5520356

iRECIST: guidelines for response criteria for use in trials testing immunotherapeutics

5 July 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=5520356

Estimation of tumour regression and growth rates during treatment in patients with advanced prostate cancer: a retrospective analysis

5 July 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=5520356

The Strength of Association Between Surrogate End Points and Survival in Oncology: A Systematic Review of Trial-Level Meta-analyses

5 July 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=5520356

FDA approval summary: crizotinib for the treatment of metastatic non-small cell lung cancer with anaplastic lymphoma kinase rearrangements

5 July 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=5520356

Pathological complete response and long-term clinical benefit in breast cancer: the CTNeoBC pooled analysis

5 July 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=5520356

Pertuzumab, trastuzumab, and docetaxel for HER2-positive metastatic breast cancer (CLEOPATRA study): overall survival results from a randomised, double-blind, placebo-controlled, phase 3 study.

5 July 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=5520356

Trastuzumab emtansine for HER2-positive advanced breast cancer

5 July 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=5520356

Everolimus in postmenopausal hormone-receptor-positive advanced breast cancer

5 July 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=5520356

Randomized controlled trials in the era of molecular oncology: methodology, biomarkers, and end points

5 July 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=5520356

Endpoints for assessing drug activity in clinical trials

5 July 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=5520356

Paclitaxel plus bevacizumab versus paclitaxel alone for metastatic breast cancer

5 July 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=5520356

Disease-free survival versus overall survival as a primary end point for adjuvant colon cancer studies: individual patient data from 20,898 patients on 18 randomized trials

5 July 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=5520356

End points and United States Food and Drug Administration approval of oncology drugs

5 July 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=5520356

Progression-free survival: meaningful or simply measurable?

5 July 2018

1 reference

https://api.crossref.org/works/10.1186%2FS12916-017-0902-9

Strength of Validation for Surrogate End Points Used in the US Food and Drug Administration's Approval of Oncology Drugs.

21 January 2018

1 reference

https://api.crossref.org/works/10.1186%2FS12916-017-0902-9

The validation of surrogate endpoints in meta-analyses of randomized experiments

21 January 2018

1 reference

https://api.crossref.org/works/10.1186%2FS12916-017-0902-9

The Trade-off Between Speed and Safety in Drug Approvals

21 January 2018

1 reference

https://api.crossref.org/works/10.1186%2FS12916-017-0902-9

Reputation and precedent in the bevacizumab decision

21 January 2018

1 reference

https://api.crossref.org/works/10.1186%2FS12916-017-0902-9

Everolimus plus exemestane for hormone-receptor-positive, human epidermal growth factor receptor-2-negative advanced breast cancer: overall survival results from BOLERO-2†.

21 January 2018

1 reference

https://api.crossref.org/works/10.1186%2FS12916-017-0902-9

The role of censoring on progression free survival: oncologist discretion advised

21 January 2018

1 reference

https://api.crossref.org/works/10.1186%2FS12916-017-0902-9

21 January 2018

Modern Drug Development

1 reference

https://api.crossref.org/works/10.1186%2FS12916-017-0902-9

Cancer Drugs Approved on the Basis of a Surrogate End Point and Subsequent Overall Survival

21 January 2018

1 reference

https://api.crossref.org/works/10.1186%2FS12916-017-0902-9

Questioning Our APHINITY for More

21 January 2018

1 reference

PubMed

https://pubmed.ncbi.nlm.nih.gov/28728605

inferred from PubMed ID database lookup

12 December 2020

based on heuristic

Surrogate threshold effect: an alternative measure for meta-analytic surrogate endpoint validation

1 reference

PubMed

https://pubmed.ncbi.nlm.nih.gov/28728605

inferred from PubMed ID database lookup

12 December 2020

based on heuristic

Quality of Life, Overall Survival, and Costs of Cancer Drugs Approved Based on Surrogate Endpoints

1 reference

PubMed

https://pubmed.ncbi.nlm.nih.gov/28728605

inferred from PubMed ID database lookup

12 December 2020

based on heuristic

Identifiers

DOI

10.1186/S12916-017-0902-9

1 reference

Dimensions Publication ID

30 July 2017

0 references

1 reference

30 July 2017

1 reference