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Re-Evaluation of Pathologic Complete Response as a Surrogate for Event-Free and Overall Survival in HER2–Positive, Early Breast Cancer Treated With Neoadjuvant Therapy Including Anti–HER2 Therapy
Abstract: Purpose Pathologic complete response (pCR) has prognostic importance and is frequently used as a primary end point, but doubts…
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Integrating Technology and Expertise
Phase I/II study in cancer patients showcases eClinical effectiveness. An Article written by IDDI Published in Applied Clinical Trials, February…
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Sample Size Re-Estimation as an Adaptive Design
Using the promising-zone approach can salvage an underpowered trial. Sample size Re-estimation (SSRE) is a relatively new concept, but, thanks…
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Operational characteristics of generalized pairwise comparisons for hierarchically ordered endpoints
Vaiva Deltuvaite-Thomas, Research Statistician, IDDI and Prof. Tomasz Burzykowski, VP Research IDDI have just published an article on operational characteristics…
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Immunotherapy against cancer: Challenge and opportunities
With some of the recently developed drugs showing unprecedented response rates and consistent improvement in overall survival in some indications,…
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Drug Development in Oncology in the Era of Precision Medicine
Cancer research is complex: trials require specific design expertise and often include biomarker and companion diagnostics, and failure rates tend…
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The Importance of Early Phase Trials in Precision Oncology
Nowadays, drug development in oncology is largely centered on the basic premise of precision medicine, according to which targeted agents…
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Considerations on the mechanics and sample sizes for early trials of targeted agents and immunotherapy in oncology
Read article on trial design and sample sizes for early trials Written by Elisabeth Coart and Everardo D. Saad, Consulting…
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Clinical Development Trends
May 25, 2021
In addition to pharmaceutical and biopharmaceutical sponsors outsourcing clinical trials to Contract Research Organizations (CROs) to gain flexibility and speed…
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Personalized Medicine: A Work in Progress
Dr. Everardo Saad, Medical Director of IDDI contributed to an article on Personalized Medicine published in the June issue of…
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