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Cancer Control Research

5R21CA108653-02
Hall, Lawrence O.
INCREASING THE ACCRUAL TO CLINICAL TRIALS

Abstract

DESCRIPTION (provided by applicant): The specific aims of this proposal are to increase accrual to clinical cancer trials. Our hypothesis is that an automated intelligent Intranet based system can be deployed to check patient eligibility for all clinical trials in a particular Cancer program and significantly increase accrual to Phase II trials. Preliminary results from the use of a prototype system at the H. Lee Moffitt Cancer Center for patient eligibility for breast cancer trials indicate that accrual can be enhanced. The utilization of the system will increase medical personnel awareness about trial availability, as well as seamlessly indicate when patients are eligible for specific trials. This Intranet based system may be deployed at affiliate sites which are physically remote from a Cancer Center and have a different patient population. We will conduct this work at the H. Lee Moffitt Cancer Center and in collaboration with the Computer Science Department at the University of South Florida. We will extend our prototype system for routine use by physicians and nurses, install it at Moffitt and use it to match patients against all Phase II trials available at Moffitt. We will ask medical professionals to enter new patient data into this system, which will screen the patients for trial participation. We will deploy the system nine months after the beginning of the project. To evaluate its effectiveness, we will compare the number of the trial participants selected before and after its deployment. We will also analyze its effectiveness in increasing the enrollment of elderly patients, minorities, and women. We will thus verify the following hypothesis, which underlies the proposed project: The use of an Intranet-based system that automatically determines eligibility for cancer clinical trials will significantly increase the number of trial participants.


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