Case Studies

Case Studies

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A Double Masked Minimization in Ophthalmology Study

Case Studies

Phase II study conducted with a dose-escalation minimization A phase II ophthalmology study was conducted with a dose-escalation minimization to…

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Developing New Biomarkers And Diagnostic Tests

Case Studies

Biostatistical Expertise For Developing New Biomarkers And Diagnostic Tests IDDI has a long-term collaboration with a Sponsor to provide biostatistical…

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Bayesian Study Design

Case Studies

A Bayesian Study Design For Seamless Transition Between Phase II And Phase III Data collected by a sponsor suggested a…

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Flexible Study Design

Case Studies

A Flexible Study Design with Randomization to Placebo The maximum tolerated dose of a new drug, supposed to alleviate some…

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Discovering New Prognostic Biomarkers For Breast Cancer

Case Studies

New prognostic biomarkers for breast cancer: A range of biological markers were analyzed by polymerase chain reaction and immunohistochemistry in…

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Meta-Analysis To Assess Efficacy in Colorectal Cancer

Case Studies

In this meta-analysis, tumor responses and survival were analyzed combining the data from the different trials using patient individual data. The…

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Applying Likelihood Method For Data Safety Monitoring

Case Studies

Data Safety Monitoring Formal data safety monitoring, often performed by independent committees of physicians, biostatisticians and ethicists, has become common…

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Validation of a Genetic Signature For Women With Node-Negative Breast Cancer

Case Studies

A 70-genetic signature was shown in a single institution to have prognostic value in patients with node-negative breast cancer. The…

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Validating Adverse Events On A Large Scale

Case Studies

Adverse Events coded by IDDI Medical Coding System Two pivotal trials were conducted (one in the US, one in Europe)…

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Jumping Ahead to Phase III trial

Case Studies

A new ophthalmic drug was going to enter a phase II dose-ranging trial in order to determine the dose to…

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