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For Sponsors

Large Clinical Trials

Large clinical trials involving common chronic conditions benefit from recruitment using Geisinger's electronic health record (EHR). CCCR has developed innovative techniques to recruit study participants using our EHR to systematically identify all patients who appear eligible for such trials. Patients satisfying broad, study specific inclusion and exclusion criteria, defined primarily by ICD and procedure codes, are identified from the EHR and invited by letter to call to learn more about the study. The disposition of each potential subject is tracked through a multi-study patient disposition database. The use of Geisinger's EHR for recruitment is ideal for studies that involve chronic disease states.

Another use of the EHR for recruiting is through the MyGeisinger patient web portal. Approximately 160,000 GHS patients access their personal EHR utilizing this tool, which has successfully been used to recruit patients into quality initiative and research programs. CCCR is in the process of developing and implementing similar methods to contact potentially eligible study subjects through the portal for clinical trial participation.

The CCCR has successfully implemented these strategies in several multi-site industry-sponsored trials in a variety of therapeutic areas to enable Geisinger to out-enroll most other sites, and even other nations.
The EHR enables Geisinger to provide realistic enrollment expectations to sponsors. Using techniques similar to those used to find and recruit, the number of patients meeting a study's inclusion/exclusion criteria can be quickly identified during a sponsor's site selection phase, ensuring appropriate expectations of performance.

The EHR also facilitates Geisinger's ability to provide accurate and timely data collection by the use of SmartSets. SmartSets are programmed screens in the patient's health record set to indicate all requisite questions, as well as necessary tests and procedures, with standardized text and drop down menus unique to each specific study visit. These screens often mirror study-specific case report forms. The use of SmartSets helps to ensure that all necessary tests or procedures are appropriately completed/ordered, thus reducing the amount of incomplete data and sponsor queries.