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INFORMATION BASED DESIGN AND INTERIM MONITORING SOFTWARE

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: N/A
Agency Tracking Number: 2R44CA084801-02
Amount: $401,681.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: N/A
Solicitation Number: N/A
Timeline
Solicitation Year: N/A
Award Year: 2001
Award Start Date (Proposal Award Date): N/A
Award End Date (Contract End Date): N/A
Small Business Information
675 MASSACHUSETTS AVE
CAMBRIDGE, MA 02139
United States
DUNS: N/A
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 CYRUS MEHTA
 () -
Business Contact
Phone: (617) 661-2011
Email: MEHTA@CYTEL.COM
Research Institution
N/A
Abstract

DESCRIPTION: It is now standard practice to incorporate formal sequential
monitoring procedures into the design and conduct of long term randomized
clinical trials. Interim monitoring provides an advance determination of
efficacy and safety so that a data and safety monitoring board can decide
whether to terminate the study early. However the integrity of a study can be
seriously compromised if the accruing data are monitored inappropriately. One
then runs the risk of attributing chance fluctuations in the data to a real
therapeutic effect. Hence one needs specialized statistical methods and
accompanying software that can balance the ethical and economic advantages of
stopping a study early against the risk of an incorrect conclusion. Research
has progressed rapidly in this area over the past two decades and methods have
been developed to meet the key practical needs. These methods are not yet
accessible to clinical trials practitioners because there exists no friendly,
professionally developed and validated software implementing them on a popular
platform such as Microsoft Windows. This Phase II SBIR proposal is intended to
fill this void. The goal is to complete the development of WinEaSt, a Windows
package for the design and interim monitoring of group sequential clinical
trials. When completed, WinEaSt will: (1) Perform group-sequential inference
for the parameters of interest from practically any type of mathematical model
including generalized linear models, parametric and semi-parametric survival
models and mixed models for longitudinal studies. (2) Permit adaptive
re-estimation of sample size, accrual period, total study duration and other
design parameters, at each interim monitoring time-point using
information-based monitoring.
PROPOSED COMMERCIAL APPLICATION: NOT AVAILABLE

* Information listed above is at the time of submission. *

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