Sunday, June 8, 2008

VCU Develops Database

Patient recruitment is an increasing challenge and it is often difficult to quickly recruit patients eligible to participate in each clinical trial. Pharmaceutical and biotechnology companies, clinical research organizations, and community physician practices, and hospitals all want to participate and enroll patients in clinical trials.

Physicians would like to introduce their patients to relevant trials and educate patients on the merits of participating in the trial. However, only 14% of patients participating in clinical trials were first informed of their trial by their doctor. The high patient volume, limited visit time, and the large number of clinical trials that are available make it difficult for clinicians to identify and discuss appropriate trials with their patients. Also, the clinical inclusion and exclusion criteria for each trial is very specific and make it complicated for clinicians to match a patient to a trial.

To address these issues, Virginia Commonwealth University researchers developed the Clinical Trials Eligibility Database (CTED) so that the clinical staff is able to prescreen patients before their office visit for eligibility to participate in clinical trials. Information is obtained from multiple electronic in-house sources including historical billing and clinical test results to build an eligibility profile for each patient.

As a visit is scheduled, the patient’s eligibility profile is automatically screened against the selection criteria for each clinical trial in CTED. When a match occurs, the clinician is informed prior to the patient’s visit, so that the trial can be discussed with the patient, and the physician is able to increase participation in clinical trials. The system enables costs to be reduced, improves efficiency, can evaluate all patients, and the system can be adapted and used with many different electronic data formats.

Within the VCU’s Massey Cancer Center, the CTED is incorporated in their Cancer Research Informatics and Services Shared Resource system. The other components in the system include the Massey Cancer Center Information System, the Automated Cancer Extraction Application, and now the Clinical Research Database System.

For more information on the system, contact the VCU Technology Transfer office at (804) 828-5188, or contact Allen Morris, Licensing Manager or call (804) 827-2211.