Cultivating Versatility in Statistical Consultants

Posted by Esha Senchaudhuri

Dec 16, 2014 4:56:00 PM

Richard Branson once wrote: “I have always valued capability over expertise. While you may need to hire specialists for some positions, take a close look at people who have thrived in different industries and jobs – they are usually more versatile, have transferable skills, and can potentially tackle problems creatively.”

He goes on to write: “Obviously a healthy mix of experience and novel...

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Topics: Nitin Patel, Cytel Consulting, Entrepreneurship, Clinical Development Strategy, Richard Branson


Drug Supply Planning for Dose-Ranging Adaptive Trials

Posted by Esha Senchaudhuri

Dec 9, 2014 12:17:28 PM

When planning a conventional trial, one can anticipate the drug supply necessary for the trial by determining how the number of patients reflected in the sample size will distribute across the trial sites. Implementing an adaptive trial, by contrast, raises many challenges for predicting the necessary drug supply. It can require planning for different sample sizes depending on the outcome of...

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Topics: Nitin Patel, Access to Slides PDF, Bayesian Methods, Interim Analyses, optimization, Dose-Finding, Adaptive Clinical Trials


Impact of Study Design and Development Strategy on Pharmaceutical Programs and Portfolios

Posted by Esha Senchaudhuri

Sep 2, 2014 11:19:00 AM

As more clinical trials make use of adaptive designs, investors have come to realize that high quality trial designs can result in significant improvements to a trial’s financial risk profile. Regardless of a trial’s eventual success or failure, a well-constructed design provides a drug with the highest possible probability of success while mitigating financial risk.

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Topics: Nitin Patel, Cyrus Mehta, Promising Zone, Trial Quality, Cytel Strategic Consulting, Trial Design, Entrepreneurship, Program and Portfolio Optimization, R&D, Adaptive Clinical Trials


Reflections on Statistical Entrepreneurship: An Interview with Nitin Patel

Posted by Esha Senchaudhuri

Aug 5, 2014 11:52:00 AM

Cytel CTO Nitin Patel, recently sat down with ECHOES (a magazine for statistics in clinical trials) to discuss his vision of the future of statistics and statistical programming within the biopharmaceutical industry.

Patel argues that the global reach of statistics in an era of big data will affect both statistical technique and communication. As a result, he encourages aspiring statisticians...

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Topics: Nitin Patel, Statistical Analysis, Entrepreneurship, Computing


The Perils of Poor Recruitment

Posted by Esha Senchaudhuri

May 5, 2014 10:21:00 PM

A new JAMA study on discontinued randomized trials in Switzerland, Germany and Canada, reports that poor recruitment accounts for 101 out of 253 trials that were eventually discontinued (or about 10% of the 1017 trials which participated in the study). When restricted to industry-sponsored trials with non-healthy volunteers, poor recruitment accounted for the discontinuation of 40 trials out...

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Topics: Nitin Patel, East, East 6.3, Access to Slides PDF, Recruitment, East Recruit, Sample Size, Promising Zone, sample size re-estimation, Adaptive Clinical Trials


StatXact 25th Anniversary: A Horizon for the Stars

Posted by Esha Senchaudhuri

Apr 21, 2014 3:57:00 PM

The core methodological problem that would eventually spur the development of Cytel’s StatXact software was first posed by Harvard’s Marvin Zelen at a computational seminar in the late 1970s. Zelen, a distinguished professor of statistical sciences and head of the Department of Biostatistics at Harvard University, was also serving as the Director of the Dana Farber Cancer Institute.

The...

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Topics: StatXact, Nitin Patel, Cyrus Mehta, White Paper, Statistics Article full PDF, Oncology, Access to Paper PDF, Exact Tests, Marvin Zelen, Statistical Puzzles


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