Charles Liu

Recent Posts

3 Questions to Ask About Your Trial's Enrollment

Posted by Charles Liu

Jul 2, 2015 1:33:01 PM

 

Clyde Haberman, a columnist for the New York Times, once commented on the remarkable consistency of train arrival times on the Tokyo subway: "Every station lists the scheduled arrival times: 9:01, 9:04, 9:08 and so on. I lived in that city for five years...I never saw a train arrive so much as a minute late, not once. A posting of 9:01 meant 9:01." [1]. Such predictability is rarely observed in the messy world of clinical operations, yet many study plans are formulated like a Tokyo subway timetable. In a previous blog entry [2], we cited an example trial that targeted 1,800 patients across 50 sites over a 10-month period. Let us examine three underlying assumptions in this plan, with the help of a modeling and simulation tool.

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Topics: feasibility studies, patient enrollment, enforesys


Patient Recruitment Feasibility: Would you bet $12 million dollars on it?

Posted by Charles Liu

Jun 4, 2015 3:11:26 PM

Two insightful papers from Applied Clinical Trials should be of interest to many clinical trial planners. The first by Kenneth Getz describes the problem of enrollment performance, while the second by Matthew Kibby proposes a potential solution.

The Facts

Getz reports a study providing recent estimates of industry-wide rates of enrollment delays [1]. In 2012, the Tufts Center for the Study of Drug Development (CSDD) requested data from 10 pharmaceutical companies and two CROs. The combined database covered nearly 16,000 investigative sites involved in 151 clinical trials from years 2008-2010. A few significant findings are worth highlighting:

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Topics: feasibility studies, patient enrollment, enforesys


Bayesian Trial Designs are Safe, Efficient & Flexible: A Review of Published Phase 1 Studies

Posted by Charles Liu

Aug 21, 2014 10:03:33 AM

 

 

Use of the continual reassessment method (CRM) is safe, efficient, and flexible, according to a comprehensive review of 53 published Phase I trials from 2003-2013. The review, just published in the Journal of Clinical Oncology by leading researchers Iasonas and O'Quigley, challenges common misconceptions about model-based dose escalation designs.

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Topics: Dose-Escalation, CRM, Phase 1


Cytel Animation: Modern Dose Escalation Phase 1 Trials

Posted by Charles Liu

Jul 15, 2014 8:00:00 AM

 

Learn More about East® ESCALATE

Do you design or analyze Phase 1 dose escalation trials? Have you considered methods other than 3+3? This new Cytel video demonstrates how East ESCALATE can help you to explore your options. 

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Topics: Dose-Escalation, Bayesian Methods, Cytel Videos


Powering Oncology Trials for Success: Adaptive Designs in East

Posted by Charles Liu

Jun 5, 2014 9:37:00 AM

CharlesLiu

Charles Liu, PhD, Cytel Statistician and Product Manager

In the US, cancer is the most common cause of death after heart disease, accounting for nearly 1 of every 4 deaths [1]. Tackling the immense burden of this disease, researchers are currently investigating an estimated 900 novel cancer agents in over 6,000 clinical trials [2]. Unfortunately, the clinical success rate remains low, and failed trials amount to billions of dollars invested, while providing little direct benefit to patients. Such failures also discourage patients from participating in the testing of novel treatments: Currently, less than 2% of cancer patients enroll in clinical trials [3].

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Topics: Oncology, Education, Adaptive Clinical Trials


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