Software for Subjective Endpoints in Clinical Trials

Award Information
Agency:
Department of Health and Human Services
Amount:
$75,137.00
Program:
SBIR
Contract:
1 R43 GM49532-1A1,
Solitcitation Year:
N/A
Solicitation Number:
N/A
Branch:
N/A
Award Year:
1994
Phase:
Phase I
Agency Tracking Number:
25085
Solicitation Topic Code:
N/A
Small Business Information
Statistics Collaborative
1816 Jefferson Place, NW, Washington, DC, 20036
Hubzone Owned:
N
Woman Owned:
N
Socially and Economically Disadvantaged:
N
Duns:
N/A
Principal Investigator
 Erica Brittain
 (202) 429-9267
Business Contact
Phone: () -
Research Institution
N/A
Abstract
Because many randomized clinical trials (RCTs) study several important outcome variables thatmay respond to treatment, evaluation of efficacy is often difficult. Objective algorithms that combineinformation from all relevant variables may not capture satisfactorily the total experience of patients.Therefore, a computer program that implements a flexible, subjective, and blinded ranking of patientsusing their entire medical history during the RCT has important commercial application for organizationsthat perform RCTs. This project describes a new procedure for endpoint determination. Raters, blindedto treatment assignment, independently rank outcomes of participants in the RCT. The procedure poolsranks across raters to determine a final "global outcome rank". A rank procedure, e.g., theMann-Whitney statistic, tests treatment effect. Phase I, which stresses applications to cardiovasculardisease, has three aims: (a) Investigation of feasibility of the approach by reanalyzing the SHEP (1) data.The rating assessments will incorporate different lengths of follow-up and varied severity of events.Phase I will (i) evaluate agreement between raters, (ii) study approaches for rating large numbers of RCTparticipants, and (iii) compare tests of treatment differences using subjective endpoints to standardmethods; (b) Consideration of general methodological issues related to statistical power in subjectiverankings; (c) Preliminary design of the prototype software package.

* information listed above is at the time of submission.

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