Application for Clinical Trial Eligibility Screening and Enrollment

Unmet need
The eligibility screening and enrollment process for clinical trial patients is extremely important for the development of drugs, biologics, medical devices, and combination therapies. Every clinical trial has unique eligibility criteria that is used to define the patient population and every potential clinical trial patient is screened to determine eligibility prior to enrollment. A source document that proves patient eligibility is required for every clinical trial enrollment and has been documented on paper historically. This process is a bottleneck for large clinical trials that can enroll thousands of patients. There is a need to automate the clinical trial eligibility screening and enrollment process and digitize the source documentation.
Technology Overview
The Application for Clinical Trial Eligibility Screening and Enrollment can be created for any clinical trial based on the clinical trial’s eligibility criteria. Once a potential patient is identified, a clinical staff member launches the application and enters the potential patient’s information into the application. Once the information is entered, the application uses a customized algorithm to determine if the potential patient is eligible or ineligible. The application programs directly into Microsoft Word to immediately generate a source document marked with the eligibility determination and saves the document to a designated folder. If the algorithm determines the patient is eligible, the application programs directly into Microsoft Outlook to generate an enrollment email with the source document attached to notify the study team of the enrollment.
Stage of Development
The Application for Clinical Trial Eligibility Screening and Enrollment is an end user product that has been created for 28 clinical trials at Johns Hopkins and is actively being used.

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