Feb 15, 2018 10:35:00 AM
A recent publication in Biometrics ‘A Gatekeeping Procedure to Test a Primary and a Secondary Endpoint in a Group Sequential Design with Multiple Interim Looks’ greatly extends the results of Glimm et al. ( 2010) and Tamhane et al ( 2010) which studied the problem of testing a primary and secondary endpoint, subject to a gatekeeping constraint, using a group sequential design (GSD) with K = 2...
Topics: Statistical Analysis, biostatistics, adaptive trials, Group Sequential, Cyrus Mehta
Jan 16, 2017 8:41:00 AM
The Global Cardiovascular Clinical Trialists Forum is a key event bringing together leading experts from across the spectrum of opinion leaders, clinical trialists, investigators, regulators, statisticians and practitioners to address the most pressing questions in cardiovascular clinical development today. At the December conference, eminent biostatisticians Cyrus Mehta and Stuart Pocock...
Topics: biostatistics, adaptive trials, adaptive designs, Cyrus Mehta, Cytel Events, Cardiovascular
Aug 17, 2016 11:57:43 AM
Following the recent publication of their review article Adaptive Designs for Clinical Trials in the New England Journal of Medicine, co-authors Cyrus Mehta ( President and Co-Founder of Cytel, and Adjunct Professor of Biostatistics at Harvard University) and Deepak L. Bhatt M.D C M.P.H. (Executive Director of Interventional Cardiovascular Programs, Brigham and Women’s Hospital Heart and...
Topics: biostatistics, adaptive trials, adaptive designs, Cyrus Mehta, Promising Zone
Mar 3, 2016 3:00:00 PM
This principle, expressed by the French essayist Joseph Joubert, applies effectively to the spirit of scientific debate. More specifically, within the clinical development space, the field of adaptive designs has seen its fair share of both discussion and progress. In this blog we’ll take a look at one debated area- the efficiency...
Topics: Cyrus Mehta, Adaptive Clinical Trials, adaptive sample size re-estimation, Lingyun Liu
Oct 5, 2015 4:14:58 PM
One consideration every sponsor of a biomarker-stratified confirmatory trial must take into account, is whether to evaluate the biomarker subpopulation (S) against the rest of the population (S') or against the full population (F).
Mathematically, one would think this makes very little difference as F is partitioned into S and S'. If the null hypothesis is rejected for both S and S' then...
Topics: Cyrus Mehta, Enrichment, Simulation & Biomarkers, time-to-even trials, Biomarkers
Sep 17, 2015 3:51:00 PM
Most people familiar with adaptive clinical trial designs are familiar with those statistical designs that reject the null hypothesis. These include now familiar designs like the promising zone design and the adaptive switch design.
A newer breed of adaptive designs, however, aims to apply adaptation techniques to confidence intervals.
Topics: Cyrus Mehta, Exact Tests, Adaptive Clinical Trials
Jun 26, 2015 12:00:06 PM
Powering a trial for superiority can be financially risky. In some instances it may also prove unnecessary.
Topics: Cyrus Mehta, Promising Zone, Cardiovascular, Adaptive Clinical Trials, Adaptive Finance
Feb 26, 2015 4:48:00 PM
Cytel President and co-founder Cyrus Mehta has co-authored a paper on Infantile Hemangioma, recently published in the New England Journal of Medicine. The successful study was designed as an adaptive confirmatory dose-response which confirmed that 3mg per kilogram per day of propranolol for 6 months is an effective resolution for hemangioma.
Topics: Cyrus Mehta
Feb 10, 2015 5:28:00 PM
Cardiovascular outcome trials (CVOTs) have earned the reputation of being the untamable behemoths of the clinical world. Needless to say these trials are long and require extremely large sample-sizes. The Contrave LIGHT study required 8900 patients. The SAVOR TIMI trial enrolled 16,492 patients. Even the EXAMINE trial, which benefited from a promising zone design, required 650 patients.
However,...
Topics: Cyrus Mehta, Promising Zone, Cytel Strategic Consulting, Interim Analyses, Program and Portfolio Optimization, Cardiovascular, Clinical Development Strategy
Sep 9, 2014 10:41:00 AM
The FDA requires sponsors of new antidiabetic drugs to conduct cardiovascular outcome trials (CVOTs). CVOTs demonstrate that new therapies do not place unacceptable cardiovascular risk on patients suffering from Type 2 diabetes. The average CVOT requires about 5000 patients and takes an average of 5 years to complete. However, a recent white paper by the Cardiac Safety Research Consortium...
Topics: Cyrus Mehta, Promising Zone, Trial Design, FDA, Interim Analyses, Cardiovascular, Adaptive Clinical Trials
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.
Topics: Nitin Patel, Cyrus Mehta, Promising Zone, Trial Quality, Cytel Strategic Consulting, Trial Design, Entrepreneurship, Program and Portfolio Optimization, R&D, Adaptive Clinical Trials
Aug 14, 2014 8:00:00 AM
Cytel statisticians are looking foward to attending the Conference of the International Society for Clinical Biostatistics, which will be held in Vienna during the week of August 24th. Members of Cytel will be contributing to four sessions at this conference, including an invited talk on innovation entitled 'Beyond Wild Horses: Developing Innovation at Cytel.' They will also be contributing to a...
Topics: Cyrus Mehta, Access to Paper PDF, Adaptive Clinical Trials
Apr 30, 2014 4:15:00 PM
For the second installment of our StatXact 25th Anniversary Retrospective Series, Professor Joan Hilton (UC San Francisco) reflects on her pioneering work on exact conditional inferences.
Topics: StatXact, Cyrus Mehta, Exact Tests, Exact tests for categorical data, Webinar Slides
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...
Topics: StatXact, Nitin Patel, Cyrus Mehta, White Paper, Statistics Article full PDF, Oncology, Access to Paper PDF, Exact Tests, Marvin Zelen, Statistical Puzzles