Blinded independent central review of progression in cancer clinical trials: Results from a meta-analysis

Amit, Ohad; Mannino, Frank; Stone, Andrew; Bushnell, William D.; Denne, Jonathan; Helterbrand, Jeffrey D.; Burger, Hans-Ulrich

doi:10.1016/j.ejca.2011.02.013

Cited by 92 publications

(109 citation statements)

References 21 publications

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“…According to no evidence of systematic bias (5,6), as well as high-degree concordance without evaluation bias between central and local assessment in previous and our meta-analysis, we consider, the implementation of central assessment for all enrolled patients is unnecessary in clinical trials. Instead, we are looking forward to understanding the usage of sample-based central review as an audit strategy in future trials (1,2,5,6,46).…”

Section: Discussionmentioning

confidence: 99%

“…Instead, we are looking forward to understanding the usage of sample-based central review as an audit strategy in future trials (1,2,5,6,46). Its value deserves further investigation.…”

Section: Discussionmentioning

confidence: 99%

“…In 2011, Amit et al conducted the first study on systematic bias according to 27 phase III RCTs (5). This study compared the treatment effects of PFS between central and local assessments through metaanalysis, and found no systematic bias.…”

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

Evaluation bias in objective response rate and disease control rate between blinded independent central review and local assessment: a study-level pooled analysis of phase III randomized control trials in the past seven years

Zhang¹,

Zhang²,

Tang³

et al. 2017

Ann. Transl. Med.

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Section: Discussionmentioning

confidence: 99%

“…Instead, we are looking forward to understanding the usage of sample-based central review as an audit strategy in future trials (1,2,5,6,46). Its value deserves further investigation.…”

Section: Discussionmentioning

confidence: 99%

See 1 more Smart Citation

Evaluation bias in objective response rate and disease control rate between blinded independent central review and local assessment: a study-level pooled analysis of phase III randomized control trials in the past seven years

Zhang¹,

Zhang²,

Tang³

et al. 2017

Ann. Transl. Med.

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“…Whether a complete case review or a sample-based audit should be conducted was discussed in the July 2012 Oncologic Advisory Committee meeting (17). Currently, 2 sample-based audit methods (6,15) have been proposed in the literature, and these 2 methods were evaluated by the FDA and presented at this advisory meeting (17,18). The committee opined that given the strong correlation between the investigator-and IRC-assessed relative PFS treatment effect, the investigator-assessed PFS treatment effect may be used in evaluating a new treatment with confirmation of no systematic bias based on a sample-based IRC audit.…”

Section: Disagreement Between Investigator and Ircmentioning

confidence: 99%

Missing Data and Measurement Variability in Assessing Progression-Free Survival Endpoint in Randomized Clinical Trials

Sridhara

Mandrekar

Dodd

2013

Clinical Cancer Research

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Progression-free survival (PFS) is frequently used as the primary efficacy endpoint in the evaluation of cancer treatment that is considered for marketing approval. Missing or incomplete data problems become more acute with a PFS endpoint (compared with overall survival). In a given clinical trial, it is common to observe incomplete data due to premature treatment discontinuation, missed or flawed assessments, change of treatment, lack of follow-up, and unevaluable data. When incomplete data issues are substantial, interpretation of the data becomes tenuous. Plans to prevent, minimize, or properly analyze incomplete data are critical for generalizability of results from the clinical trial. Variability in progressive disease measurement between radiologists further contributes to data problems with a PFS endpoint. The repercussions of this on phase III clinical trials are complex and depend on several factors, including the magnitude of the variability and whether there is a systematic reader evaluation bias favoring one treatment arm particularly in open-label trials.

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“…Complete blinded independent central radiological review (BICR) has been the regulatory standard for trials using PFS as the primary endpoint, although the systematic use of this complex review tool has been challenged (12)(13)(14)(15). According to one proposal, for instance, the need for complete BICR could be reduced after assessing the risk of important bias in the treatment comparison based on an independent review of only a random sample of patients (14). Further reflection is needed on defining situations where complete and, if necessary, real-time BICR is needed, as opposed to situations where more efficient and risk-adapted approaches are possible.…”

Section: Pfs As a Primary Endpoint For Registrationmentioning

confidence: 99%

The European Medicines Agency: An Overview of Its Mission, Responsibilities, and Recent Initiatives in Cancer Drug Regulation

Pignatti

Gravanis

Herold

et al. 2011

Clinical Cancer Research

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The European Medicines Agency (EMA) is responsible for the scientific evaluation of medicines developed by pharmaceutical companies for use in the European Union (EU). Since 2005, the agency has become responsible for the approval of all new oncology drugs in the EU. In this article we describe the mission, role, and responsibilities of the EMA, and provide a brief summary of recent initiatives related to cancer drug regulation. The EMA recently published its Road Map to 2015. Over the next 5 years, the agency aims to continue to stimulate drug development in areas of unmet medical needs. Concerning drug safety, one of the priorities over the next few years will be to establish a more proactive approach in ensuring patient safety. This is the result of new EU legislation coming into force in 2012 that will strengthen the way the safety of medicines for human use is monitored in the EU. In terms of its general operation, the agency is committed to increased openness and transparency, and to build on its interactions with stakeholders, including members of academia, health care professionals, patients, and health technology assessment bodies. The agency recently created an oncology working party to expand the current guideline for the development and evaluation of cancer drugs. The guideline focuses on both exploratory and confirmatory studies for different types of agents. The current revision will address a number of topics, including the use of biomarkers as an integrated part of drug development and the use of progression-free survival as a primary endpoint in registration trials.

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Blinded independent central review of progression in cancer clinical trials: Results from a meta-analysis

Cited by 92 publications

References 21 publications

Evaluation bias in objective response rate and disease control rate between blinded independent central review and local assessment: a study-level pooled analysis of phase III randomized control trials in the past seven years

Evaluation bias in objective response rate and disease control rate between blinded independent central review and local assessment: a study-level pooled analysis of phase III randomized control trials in the past seven years

Missing Data and Measurement Variability in Assessing Progression-Free Survival Endpoint in Randomized Clinical Trials

The European Medicines Agency: An Overview of Its Mission, Responsibilities, and Recent Initiatives in Cancer Drug Regulation

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