Cytel Consulting

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7 Reasons to Add a Statistical Consultant to Your Team

Posted by Cytel Consulting

Oct 14, 2014 11:05:00 AM

We are often asked how statistical consultants can add value to the clinical development process. What do they contribute to a winning strategy, and how do they optimize business decisions? 

Statistical consultants often have decades of experience in multiple aspects of clinical development, including trial design, portfolio optimization, and regulation. Having a broad and yet nuanced feel for the industry enables statistical consultants to generate novel solutions to an array of challenges faced while navigating clinical development.

If you are thinking of hiring a statistical consultant to your team, you should be aware of the many roles that they can play. Here are some of our consultants' favorite recent projects. 

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Topics: Data Management, Cytel Strategic Consulting, Cytel Consulting


Adaptive Clinical Trials: Your Questions Answered

Posted by Cytel Consulting

Sep 23, 2014 11:32:07 AM

If you're a company considering an adaptive trial for the first time, you probably have many questions. One of our customers recently sat down with us to discuss some anxieties about an adaptive trial. The ensuing discussion included senior members of Cytel Consulting. Here's a transcript of  our conversation. 

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Cytel Joins DIA Discussion on Predictive Enrichment Strategies

Posted by Cytel Consulting

May 16, 2014 2:48:00 PM

Cytel Consulting's Zoran Antonijevic

The key focus of precision medicine is identification of patients who would most benefit from a treatment. Proper enrichment of patient population greatly improves the probability of regulatory approval as well as product differentiation through improved efficacy and safety. Greater product differentiation leads to greater market access, as reimbursement is now a key driver to commercial success.

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Topics: Enrichment, Cytel Consulting, Adaptive Clinical Trials


New JAMA Study Confirms Importance of Trial Design for FDA Approval

Posted by Cytel Consulting

Apr 24, 2014 11:00:00 AM

Here at Cytel we firmly believe that if you don’t get the design of a clinical program right, then nothing else matters. A study recently published by the Journal of the American Medical Association, once again confirms the vital importance of proper trial design for the timely approval of a new drug. The article reports that nearly half of all submitted NME applications fail upon first submission, and only half of those that fail are eventually approved. The median approval delay is a costly 435 days. At least 53.6% of the trials eventually approved would have benefitted from improved study design: 24 of the unsuccessful first-time applications (15.9%) resulted from uncertainties related to dose selection; 20 of the rejections (13.2%) were due to choice of study end points that failed to display a clinically meaningful effect; 20 of the rejections (13.2%) were a consequence of inconsistent results when different end points were tested; and 17 (11.3%) demonstrated inconsistent results when different trials or study sites were compared. Moreover, 89 (58.9 %) showed inadequate efficacy, raising a question about whether the dose had been selected properly.

Cytel has biostatisticians with broad experience in clinical trial and clinical development program design, including adaptive designs and designs for efficient dose-finding. We are eager to collaborate on your clinical programs to enhance their probabilities of success.

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Topics: Cytel Consulting, Trial Design, Efficacy, Regulation, Safety


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