Don’t miss these 5 session picks at JSM

Posted by Cytel

Jul 25, 2017 7:37:09 AM

The Joint Statistical Meetings (JSM) is the largest and arguably most highly respected gathering of statisticians in the world.  It will bring together over 6000 statisticians and runs from Saturday, July 29, to Thursday, August 3, 2017. With over 600 sessions,  it can be a challenge to identify the most crucial ones to attend. To help out, we've asked some of the Cytel team for their top picks this year. 

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Topics: Oncology, Clinical Research Services, Statistical Programming, Statistical Analysis, Clinical Development Strategy, Adaptive Clinical Trials, Statistical Innovations in Clinical Development, biostatistics


It’s Time to Bridge the Gap Between Pharmacometrics and Biostats

Posted by Esha Senchaudhuri

Oct 1, 2015 5:22:00 PM

This week marks the sixth annual American Conference on Pharmacometrics, held this year in Crystal City, VA. Situated at the intersection of mathematical modeling, simulation and big data, the field of pharmacometrics is delivering on its promise to revolutionize clinical research and by extension clinical development.

No wonder then that biostatisticians are now fully engaged with the enterprise.  

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Topics: Adaptive Clinical Trials, Statistical Innovations in Clinical Development, pharmacometrics


Relative Clinical Efficiency and Phase 2 Biomarker Studies

Posted by Esha Senchaudhuri

Apr 9, 2015 11:37:00 AM

Last year. Nature Reviews Drug Discovery asked the FDA’s Tatiana Prowell (Hematology & Oncology Products Division) about the most common pitfalls confronting clinical trials in oncology. She cited the late stage evaluations of biomarkers as one of three critical issues leading to regulatory failure [1]. The primary lesson: those who want to test biomarkers need to start earlier.  

OncoMed’s Eric Holmgren recently expanded on the nature of the problem, at a Cytel and ASA sponsored symposium on Statistical Innovations in Clinical Development. According to Holgren, the use of biomarker testing during Phase 2 can satisfy many forward-looking objectives. The objectives to prioritize, however, should depend quite significantly on a clinical trial sponsor’s resource constraints and asset value, and in particular on pre-Phase 2 costs. He considers three scenarios to illustrate how the investment undertaken in pre-Phase 2 studies should shape the objectives of Phase 2.

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Topics: Oncology, Predictive Enrichment, Precision Medicine, Clinical Development Strategy, Statistical Innovations in Clinical Development


Statistical and Operational Challenges of the VALOR Trial: Mehta on the Promising Zone

Posted by Esha Senchaudhuri

Mar 26, 2015 4:00:00 PM

Last year Sunesis completed the VALOR trial, the first clinical study to make use of the groundbreaking promising zone design. The promising zone design implements an unblinded sample re-estimation after an interim look, but only if conditional power during the interim look falls within a designated promising zone. Although the VALOR trial did not confirm the efficacy of the new therapeutic, it provided the drug with the best possible chance to prove its efficacy.

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Topics: Promising Zone, Adaptive Clinical Trials, Statistical Innovations in Clinical Development


How to Plan Interim Looks in Adaptive Clinical Trials: 3 Strategies

Posted by Esha Senchaudhuri

Mar 19, 2015 5:26:00 PM

A well-timed interim analysis can generally supply added benefits to the operational and administrative aspects of a clinical trial. Particularly when clean data and safety adjudications provide information that is instrumental for stopping a trial early or informing sensitive interim decisions, the timing of an interim look may play a crucial role in leveraging all of the flexibility that a complex, adaptive design has to offer. 

 
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Topics: Interim Analyses, Cardiovascular, Cytel Events, Statistical Innovations in Clinical Development


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