A comparison between the assessments of progression-free survival by local investigators versus blinded independent central reviews in phase III oncology trials-Reference-Cited by-同舟云学术

A comparison between the assessments of progression-free survival by local investigators versus blinded independent central reviews in phase III oncology trials

Published:2020-05-24 Issue:8 Volume:76 Page:1083-1092
ISSN:0031-6970
Container-title:European Journal of Clinical Pharmacology
language:en
Short-container-title:Eur J Clin Pharmacol

Author:

Dello Russo Cinzia,Cappoli Natalia,Navarra Pierluigi^ORCID

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Pharmacology,General Medicine

Link

https://link.springer.com/content/pdf/10.1007/s00228-020-02895-z.pdf

Reference43 articles.

1. Day SJ, Altman DG (2000) Statistics notes: blinding in clinical trials and other studies. BMJ 321:504. https://doi.org/10.1136/bmj.321.7259.504

2. Schulz KF, Grimes DA (2002) Blinding in randomised trials: hiding who got what. Lancet 359:696–700

3. Dodd LE, Korn EL, Freidlin B, Jaffe CC, Rubinstein LV, Dancey J, Mooney MM (2008) Blinded independent central review of progression-free survival in phase III clinical trials: important design element or unnecessary expense? J Clin Oncol 26:3791–3796

4. Guidance for industry, clinical trial endpoints for the approval of cancer drugs and biologics (2007) Available from: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm071590.pdf.

5. Guideline on the evaluation of anticancer medicinal products in man (2006) Available from: http://www.ema.europa.eu/ema/pages/includes/document/open_document.jsp?webContentId=WC500017748

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