Cytel
| Type | Privately held |
|---|---|
| Industry | Clinical trial services and statistical software |
| Key people | Cyrus Mehta, Ph.D., Co-founder and President, Nitin Patel, Ph.D. Co-founder and CTO. |
| Products | East, LogXact, StatXact |
| Employees | 140 worldwide |
| Website | www.cytel.com |
Headquartered in Cambridge, MA, USA, Cytel Inc. provides clinical trial design services and specialized statistical applications primarily for the biotech and pharmaceutical research markets.
Cytel specializes in adaptive trials – a rapidly emerging type of randomized clinical trial that allows modifications of ongoing trials while aiming to preserve the statistical validity and integrity of the study. Based on either frequentist or Bayesian statistics, adaptive trial designs are being increasingly accepted by government regulatory agencies including the United States Food and Drug Administration, EMEA, and MHRA in both early and later stage clinical studies.
As of January 2010, the company claims 47 of the top 50 biopharmaceutical companies as users of its software to design, simulate and analyze trials.
Background
Company founders Cyrus Mehta, Ph.D. and Nitin Patel, Ph.D. are amongst the pioneering statisticians credited for developing the underlying statistical methods behind so-called “flexible” designs: group sequential and adaptive trials.
Cytel statisticians have collectively published over 120 papers in peer-reviewed statistical and medical journals, including The Journal of the American Statistical Association, The Journal of Biopharmaceutical Statistics, Biometrics, Biometrika, Circulation and Statistics in Medicine.
Clinical Research Services
- Clinical development program planning
- Early and late stage trial design
- Drug / clinical supply forecasting
- Randomization and IVRS schemes
- Statistical Analysis Plan (SAP) development
- Interim and final data analysis
- DMC / DSMB organization, independent statistician representation
- Medical writing
- Migration of clinical data to CDISC standards
- Trial safety and efficacy data Integration
- Common Technical Document (CTD) preparation
- Integrated data analysis
Products
East
Clinical trial statistical software for the design, simulation and monitoring of adaptive, group sequential and fixed sample size trials. As of 2009, East 5 is in use at over 140 pharmaceutical and biotechnology companies, research centers and regulatory agencies including the FDA’s CDER, CBER and CDRH divisions.
First introduced by the Cytel Software Corporation in 1995 as “East DOS”, the name is derived from the benefit of “Early stopping” a trial due to futility: a failure of the tested treatment to demonstrate significant improvement over an existing treatment and/or placebo.
StatXact
Statistical software based on the exact branch of statistics used for small-sample categorical and nonparametric data problem solving. Utilized by statisticians and researchers in all fields of study, the StatXact package now offers 141 different statistical tests and procedures.
Initially offered in 1989 as StatXact DOS, StatXact 8 was released in 2007. The StatXact PROCs variant integrates with the popular SAS statistical software.
LogXact
A logistic regression predictive modeling software package suited particularly to cases involving small samples and / or missing data. Logistic regression is used extensively in the medical and social sciences as well as marketing applications to predict subject behavior.
First made available in 1996 under the name LogXact Turbo, LogXact 8 was introduced in 2007. The LogXact PROCs variant integrates with the popular SAS statistical software.
SiZ
Design, Simulation, Analysis of trial options. Comparison of designs. Primarily meant for fixed sample size designs. Includes a comprehensive set of tests and methods also including non-inferiority and equivalence designs. Easy to use and inexpensive (List price $245 in January 2010).
Locations
- Corporate headquarters, Cambridge, MA, USA
- Development and programming, Philadelphia, PA, USA
- Cytel India operations, Pune, INDIA
- Offices in Paris, FRANCE and San Jose, CA USA
References
Trial Design Methodology Development
1. Sample Size Re-estimation for Adaptive Sequential Design in Clinical Trials
Ping Gao, Cyrus R. Mehta and James H. Ware
Journal of Biopharmaceutical Statistics, 2008
2. Exact Confidence Bounds Following Adaptive Group Sequential Tests
Werner Brannath, Cyrus R. Mehta and Martin Posch
Biometrics Journal, 2008 (a published reference of East by leading Pfizer statisticians)
3. Planning for an Adaptive Design: a Case Study in COPD (Chronic Obstructive Pulmonary Disease)
http://www.ncbi.nlm.nih.gov/pubmed/17080770
Statistical Methodology Development
1. Confidence Interval of the Difference of Two Independent Binomial Proportions Using Weighted Profile Likelihood
http://www.informaworld.com/smpp/content~content=a791517658
Vivek Pradhan (section a) and Tathagata Banerjee (sections b,c)
Section a - Cytel Inc, Cambridge, Massachusetts, USA. Section b - Indian Institute of Management, Ahmadabad, India. Section c - Department of Statistics, University of Calcutta, Kolkata, India.
Communications in Statistics - Simulation and Computation, 2008
2. Small-sample Comparisons of Confidence Intervals for the Difference of Two Independent Binomial Proportions
Thomas J. Santner, Vivek Pradhan, Pralay Senchaudhuri, Cyrus R. Mehta, and Ajit Tamhane
Computational Statistics & Data Analysis 51 (2007) 5791 – 5799, August, 2007
3.Statistical Techniques for Comparing Measurers and Methods of Measurement: A Critical Review
John Ludbrook, Univ. of Melbourne, Parkville, Victoria, Australia.
Clinical and Experimental Pharmacology and Physiology (2002) 29, pp 527-536 + addendum
Logistic Methodology Development
1. Bias Reduction and a Solution for Separation of Logistic Regression with Missing Covariates
Tapabrata Maiti a, Vivek Pradhan b
a Department of Statistics and Probability,
Michigan State University, East Lansing, MI 48824, USA
b Cytel Inc, Cambridge, MA 02139, USA
Biometrics Journal, 2008
2. Efficient Monte Carlo Methods for Conditional Logistic Regression
Cyrus R. Mehta, Nitin R. Patel and Pralay Senchaudhuri
Cytel Software Corporation
Journal of the American Statistical Association, March 2000, Vol. 95, No. 449, Theory and Methods, pp 99-108
