A Double Masked Minimization in Ophthalmology Study
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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Resources
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Developing New Biomarkers And Diagnostic Tests
Biostatistical Expertise For Developing New Biomarkers And Diagnostic Tests IDDI has a long-term collaboration with a Sponsor to provide biostatistical…
Bayesian Study Design
A Bayesian Study Design For Seamless Transition Between Phase II And Phase III Data collected by a sponsor suggested a…
Flexible Study Design
A Flexible Study Design with Randomization to Placebo The maximum tolerated dose of a new drug, supposed to alleviate some…
Discovering New Prognostic Biomarkers For Breast Cancer
New prognostic biomarkers for breast cancer: A range of biological markers were analyzed by polymerase chain reaction and immunohistochemistry in…
Meta-Analysis To Assess Efficacy in Colorectal Cancer
In this meta-analysis, tumor responses and survival were analyzed combining the data from the different trials using patient individual data. The…
Applying Likelihood Method For Data Safety Monitoring
Data Safety Monitoring Formal data safety monitoring, often performed by independent committees of physicians, biostatisticians and ethicists, has become common…
Validation of a Genetic Signature For Women With Node-Negative Breast Cancer
A 70-genetic signature was shown in a single institution to have prognostic value in patients with node-negative breast cancer. The…
Validating Adverse Events On A Large Scale
Adverse Events coded by IDDI Medical Coding System Two pivotal trials were conducted (one in the US, one in Europe)…
Jumping Ahead to Phase III trial
A new ophthalmic drug was going to enter a phase II dose-ranging trial in order to determine the dose to…