DESIGN POWER SOFTWARE FOR CLINICAL STUDIES

Award Information
Agency: Department of Health and Human Services
Branch: N/A
Contract: N/A
Agency Tracking Number: 16406
Amount: $500,000.00
Phase: Phase II
Program: SBIR
Awards Year: 1993
Solicitation Year: N/A
Solicitation Topic Code: N/A
Solicitation Number: N/A
Small Business Information
7735 Old Georgetown Road, #410, Bethesda, MD, 20814
DUNS: N/A
HUBZone Owned: N
Woman Owned: N
Socially and Economically Disadvantaged: N
Principal Investigator
 Bunow, Barry J
 Principal Investigator
 (301) 652-4714
Business Contact
 1 R43 CA54004-01
Phone: () -
Research Institution
N/A
Abstract
THIS GRANT CONCERNS PC SOFTWARE TO COMPUTE SAMPLE SIZE AND STATISTICAL POWER FOR THE DESIGN OF BIOMEDICAL STUDIES. FOR PHASE I, OUR PROGRAM WILL IMPLEMENT TWO NOVEL SIMULATIONS FOR THE DESIGN OF TIME-TO-EVENT STUDIES: A METHOD OF HALPERN AND BROWN [1987] THAT USES EXISTING SURVIVAL DATA, PERHAPS TAKEN FROM PUBLISHED ARTICLES, TO ESTIMATE SAMPLE SIZE AND POWER FOR A NEW STUDY, AND A METHOD WE DEVELOPED FOR STUDIES IN WHICH ACCUMULATING SURVIVAL DATA ARE RE-ANALYZED AT EACH UPDATE. PHASE I WILL ALSO INCLUDE A POWER CALCULATION FOR REPEATED MEASURES (LONGITUDINAL) STUDIES WITH CONTINUOUS OUTCOMES. NONE OF THESE IS AVAILABLE IN CURRENT DESIGN SOFTWARE. OUR PHASE II PACKAGE WILL INCLUDE EASY, GRAPHICAL EXPLORATION OF TRADEOFFS BETWEEN DESIGN FEATURES, CALCULATIONS FOR A WIDE RANGE OF CLINICAL AND EPIDEMIOLOGICAL DESIGNS AND CONTEXT-SENSITIVE ADVICE TO THE INTENDED USER (E. G., PHYSICIAN CONCERNED WITH STUDY DESIGN OR STATISTICIAN). RECENT REVIEWS OF THIS PRODUCT CATEGORY SUGGEST A SUBSTANTIAL DEMAND FOR COMPREHENSIVE, FLEXIBLE DESIGN SOFTWARE FOR MEDICAL, ENVIRONMENTAL AND INDUSTRIAL STUDIES BUT THAT THE CURRENT STATE IS UNSATISFACTORY. WE HAVE STUDIED THESE REVIEWS AND THE SOFTWARE AND BELIEVE THAT OUR PRODUCT IS MORE INFORMATIVE, MORE COMPREHENSIVE, AND MORE ATTRACTIVE.

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

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