Cytel
Encyclopedia
Headquartered in Cambridge, MA, USA, Cytel Inc. provides clinical trial
Clinical trial
Clinical trials are a set of procedures in medical research and drug development that are conducted to allow safety and efficacy data to be collected for health interventions...
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
Frequency probability
Frequency probability is the interpretation of probability that defines an event's probability as the limit of its relative frequency in a large number of trials. The development of the frequentist account was motivated by the problems and paradoxes of the previously dominant viewpoint, the...
or Bayesian statistics
Bayesian statistics
Bayesian statistics is that subset of the entire field of statistics in which the evidence about the true state of the world is expressed in terms of degrees of belief or, more specifically, Bayesian probabilities...
, adaptive trial designs are being increasingly accepted by government regulatory agencies including the United States Food and Drug Administration
Food and Drug Administration
The Food and Drug Administration is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments...
, EMEA
European Medicines Agency
The European Medicines Agency is a European agency for the evaluation of medicinal products. From 1995 to 2004, the European Medicines Agency was known as European Agency for the Evaluation of Medicinal Products.Roughly parallel to the U.S...
, and MHRA
Medicines and Healthcare products Regulatory Agency
The Medicines and Healthcare products Regulatory Agency is the UK government agency which is responsible for ensuring that medicines and medical devices work and are acceptably safe....
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
Journal of the American Statistical Association
The Journal of the American Statistical Association is the most prestigious journal published by the American Statistical Association, the main professional body for statisticians in the United States...
, The Journal of Biopharmaceutical Statistics, Biometrics
Biometrics (Journal)
Biometrics is a journal that publishes articles on the application of statistics and mathematics to the biological sciences. It is published by the International Biometric Society....
, Biometrika, Circulation
Circulation (journal)
Circulation is a scientific journal published by Lippincott Williams & Wilkins for the American Heart Association. The journal publishes articles related to research in and the practice of cardiovascular diseases, including observational studies, clinical trials, epidemiology, health services and...
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
- Statistical Programming for Tables, Listings, Graphs
- Interim and final data analysis
- DMCData Monitoring CommitteesA Data Monitoring Committee — sometimes called a Data and Safety Monitoring Board — is an independent group of experts who monitor patient safety and treatment efficacy data while a clinical trial is ongoing.- Need for a DMC :...
/ DSMB organization, independent statistician representation - Medical writingMedical writingMedical writing is the activity of producing scientific documentation by a specialized writer. The medical writer typically is not one of the scientists or doctors who performed the research....
- Migration of clinical data to CDISCClinical Data Interchange Standards ConsortiumClinical Data Interchange Standards Consortium is a non-profit organization, whose mission is "to develop and support global, platform-independent data standards that enable information system interoperability to improve medical research and related areas of health-care". Their main project, the...
standards - Trial safety and efficacy data Integration
- Common Technical Document (CTD) preparation
- Integrated data analysis
Products
EastClinical 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
Center for Drug Evaluation and Research
The Center for Drug Evaluation and Research is a division of the U.S. Food and Drug Administration that monitors most drugs as defined in the Food, Drug, and Cosmetic Act. Some biological products are also legally considered drugs, but they are covered by the Center for Biologics Evaluation and...
, CBER
Center for Biologics Evaluation and Research
The Center for Biologics Evaluation and Research is one of six main centers for the U.S. Food and Drug Administration , which is a part of the U.S. Department of Health and Human Services. The current Director of CBER is Dr. Karen Midthun, M.D...
and CDRH
Center for Devices and Radiological Health
The Center for Devices and Radiological Health is the branch of the United States Food and Drug Administration responsible for the premarket approval of all medical devices, as well as overseeing the manufacturing, performance and safety of these devices...
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
Placebo-controlled studies
A Placebo-controlled study is a way of testing a medical therapy in which, in addition to a group of subjects that receives the treatment to be evaluated, a separate control group receives a sham "placebo" treatment which is specifically designed to have no real effect...
.
Compass
Largely the result of a co-development project with a top 3 pharmaceutical company, Compass is used by biostatisticians and clinicians to plan and design earlier stage adaptive clinical trials (traditionally known as phase 1 human tolerance and phase 2 dose-selection
Dose-ranging study
A dose-ranging study is a clinical trial where different doses of an agent are tested against each other to establish which dose works best and/or is least harmful....
studies).
Compass is the first commercially-offered adaptive trial composition software with both frequentist and Bayesian methods. Other key capabilities include R code integration
R (programming language)
R is a programming language and software environment for statistical computing and graphics. The R language is widely used among statisticians for developing statistical software, and R is widely used for statistical software development and data analysis....
, trial simulation compute engines, plus various tables, charts and graphs to visualize and communicate trial design attributes.
SiZ
SiZ provides a more modern clinical trial planning approach by combining design, simulation and comparison of trial options and study data analysis within a single interface. SiZ is primarily meant for fixed sample size designs including non-inferiority and equivalence designs.
StatXact
Statistical software based on the exact branch of statistics
Exact statistics
Exact statistics, such as that described in exact test, is a branch of statistics that was developed to provide more accurate results pertaining to statistical testing and interval estimation by eliminating procedures based on asymptotic and approximate statistical methods...
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
SAS System
SAS is an integrated system of software products provided by SAS Institute Inc. that enables programmers to perform:* retrieval, management, and mining* report writing and graphics* statistical analysis...
.
LogXact
A logistic regression
Logistic regression
In statistics, logistic regression is used for prediction of the probability of occurrence of an event by fitting data to a logit function logistic curve. It is a generalized linear model used for binomial 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
SAS System
SAS is an integrated system of software products provided by SAS Institute Inc. that enables programmers to perform:* retrieval, management, and mining* report writing and graphics* statistical analysis...
.
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