Systematic bias between blinded independent central review and local assessment: literature review and analyses of 76 phase III randomised controlled trials in 45 688 patients with advanced solid tumour.

ABSTRACT:

Objective

Unbiased assessment of tumour response is crucial in randomised controlled trials (RCTs). Blinded independent central review is usually used as a supplemental or monitor to local assessment but is costly. The aim of this study is to investigate whether systematic bias existed in RCTs by comparing the treatment effects of efficacy endpoints between central and local assessments.

Design

Literature review, pooling analysis and correlation analysis.

Data sources

PubMed, from 1 January 2010 to 30 June 2017.

Eligibility criteria for selecting studies

Eligible articles are phase III RCTs comparing anticancer agents for advanced solid tumours. Additionally, the articles should report objective response rate (ORR), disease control rate (DCR), progression-free

SUBMITTER: Zhang J 

PROVIDER: S-EPMC6144327 | biostudies-literature | 2018 Sep

REPOSITORIES: biostudies-literature