Clinical Trials Eligibility Database
The Clinical Trials Eligibility Database (CTED) is composed of the CTED Tracking system and the CTED Automated Matching Tool (AMT). The CTED tools are used by research staff in pre-screening patients for eligibility in clinical trials, and to facilitate comprehensive patient-subject identification preparatory to research.
CTED Tracking is based on a daily download of cancer patient visits scheduled for the next two weeks. Once in CTED data are linked longitudinally with UDS clinical data to provide near real time clinical information to evaluate patients for eligibility prior to their scheduled visit. CTED data are used in identification of patients preparatory to research under a VCU IRB-approved protocol.
CTED Tracking Tool
The function of the CTED Tracking Tool is threefold. First, to provide linked and integrated clinical information permitting rapid screening of patients with scheduled visits. Second, the tool serves as a tracking system to capture key information on all screened patients, not just those eligible or consented for studies and captured in Oncore®. Third, it provides a single integrated system in which all research staff can follow and annotate pending patients. The tool has been in production since January, 2010 and is being used in support of all 177 open studies at VCU Massey Cancer Center. The primary data entry screen for CTED Tracking (Figure 2) permits staff to record data for each study evaluation and its outcome, including reasons for ineligibility or refusal to participate. For each evaluation, staff indicates the trial for which the patient is evaluated and completes information on eligibility status as well as referring physician and effort expended on each evaluation. This information is a unique and critical component of the system and these data are being used to inform cancer center leadership, clinicians, and research staff on clinical trial activity. We have developed several reports that physicians and research staff receive monthly. The report to physicians provides clinical trial-specific, performance-based feedback, on all individual physicians, with referral rates, and number of unique patients seen each month. The report to the research staff provides research division-specific activity including evaluations, their outcomes, and effort. Data from CTED are being used to develop interventions to directly target local patient-specific barriers to clinical trial participation. Based on these data, Massey has hired a social worker to address barriers related to out of pocket expenses, family care etc. that may prevent patients from enrolling in a clinical trial.
CTED Automated Matching Tool (AMT)
Unlike the CTED tracking tool which focuses on cancer patients with scheduled visits, the CTED AMT directly accesses the superset of all patients seen at VCUHS (in UDS) to directly match patient clinical and demographic characteristics with specific clinical trial eligibility requirements. This expanded patient population permits the identification of potentially eligible patients independent of visit schedule. The AMT provides a user interface that allows research staff to create a query for a specific trial based on discrete eligibility requirements and to automatically match these against patient characteristics in the electronic data on a scheduled basis. The system permits text string searching, use of indexed text documents identifying particular criteria (e.g., presence of metastatic disease from radiology reports) and discrete data such as billing codes and clinical laboratory test results. Through the user interface, eligibility requirements are entered for specific studies related to: diagnosis, histology, stage, tumor characteristics, comorbidity, clinical laboratory test result requirements, and history of treatment including specific chemotherapeutic agents. AMT also permits staff to develop customized queries searching on user-defined text strings (either through the live link with the caBIG EVS cancer terms metathesaurus) or custom terms/text strings.
The results of the query are then automatically integrated with the CTED tracking system to permit further evaluation. The AMT provides the following advantages: 1) It assures that every patient is screened for each trial regardless of visit schedule or provider; 2) repeated scheduled evaluations or over the patients disease course as their clinical status changes; 3) patients may be simultaneously evaluated for multiple studies; 4) it increases the likelihood of eligibility assessment in a timely manner by enhancing the efficiency of the pre-screening process; and 5) it reduces the time research staff spend pre-screening patients not likely to be eligible.