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AN ADAPTIVE SOFTWARE SOLUTION TO MANAGE PARTICIPANT RECRUITMENT, SCREENING AND TRACKING FOR CLINICAL TRIALS

The 27th annual ACM SI/GUCCS conference



Abstract

Purpose

Clinical trials for common health conditions are constantly being designed and implemented in our institution, often with some urgency to meet funding deadlines. The scope and complexity of these trials has resulted in the need for databased computer management systems typically tailored to each project. Even with current advanced software resources, development, testing and implementation can take months for each new project. This presentation describes a new approach to this problem involving an adaptive table-driven software system using project-specific recruitment and screening data which we have developed using visual basic.

Methods

The chief design criterion was that the software be reconfigurable by the user based on data tables that contain the parameters of the project design. Essentially, each new project would be implemented by generating new input to the tables, but without the need for reprogramming. The first system implemented was a branching phone screen application that presents questions in an interview format and records participant responses in a data table which can be judged against inclusion/exclusion criteria contained in another table as well as for status reports.

Conclusion

The phone screen system is complete and has been implemented in two trials at our institution. Loading the data tables as required to implement the second trial was completed in 1 week. These methods demonstrate the possibility of using careful program design to enable rapid deployment across all phases of the project timeline: in-house clinical screening, treatment and follow-up.

Conflicts of interest: None

Sources of funding: United States Health Resources and Services Administration