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Executive Summary: EncounterSuite is a Web-based integrated Personal Health Record/Electronic Medical Record (PHR/EMR) that can dramatically reduce the cost and duration of clinical trials. EncounterSuite’s prospective clinical trial alerting system notifies the physician that his current patient may be eligible for a clinical trial, improving patient recruitment. EncounterSuite’s Patient Generated Medical History (PGMH) can record a clinical trial subject’s evaluations between office visits resulting in more frequent, contemporaneous, and accurate data collection. Trial protocol compliance can be enhanced using EncounterSuite’s Treatment Favorites and Inbox. EncounterSuite’s content and data structure would yield useful pharmacoepidemiological data. Its centralized data center makes trial administration easier. EncounterSuite is a Web-based integrated Personal Health Record/Electronic Medical Record (PHR/EMR). EncounterSuite has several unique features that facilitate clinical trials recruitment and performance which are integrated into the outpatient physician’s workflow. In EncounterSuite, the content is the same across all sites and the data is stored in a relational database. Diagnostic equivalence is the technique where EncounterSuite can identify all patients with the same disease. For example, patients with hypertension and patients with high blood pressure would both be included in a search of hypertensive patients. EncounterSuite has a Patient Generated Medical History (PGMH). In the PGMH, the computer creates a comprehensive patient medical history through adaptive questionnaire technology. The system asks follow-up questions based on the patient’s positive responses resulting in a customized questionnaire for each patient. The patient can perform the PGMH at home. The features can dramatically reduce the cost and duration of clinical trials. Here’s how. Patient Recruitment
Presently patient recruitment for clinical trials depends on the memory of the physician and staff. In a busy practice, this process is error prone and limits the number of studies screened. EncounterSuite has a prospective clinical trial alerting system. A dashboard indicates that number of trials the current patient is eligible for. The details of the clinical trials can be displayed. Patient recruitment would be enhanced when the physician can discuss trial participation with the patient during the office visit. EncounterSuite determines trial eligibility criteria based on the patient’s demographics and his medical conditions. Diagnostic equivalence ensures that all patients who have the same medical conditions required in the study are identified. The prospective clinical trial alerting system has several advantages. •Physicians do not need to know about individual clinical trials. Only when a clinical trial has been matched to the patient is the physician informed. •Physicians need only agree to recruit patients. Specific clinical trials can be added and deleted to the trial screening list and eligibility criteria modified without needing to inform the recruiting physicians. Recording Trial Subject’s Responses
The PGMH enables the clinical trial administrator to assess trial subjects’ subjective responses more frequently and in a uniformed manner. Since the PGMH can be performed at home, the subject can be queried about his responses to the trial between visits. Studies have shown that more frequent sampling of a subject’s subjective responses results in more accurate data. The PGMH presents the questions and responses to each subject in same way. When staff record the trial subjects’ responses, inter-site variation can occur; one staff’s interpretation of a complaint might be loose stools while another staff’s interpretation of the same complaint is diarrhea. The PGMH can follow-up on a subject’s reported side-effects. For instance, is the diarrhea nocturnal, mucinous, bloody, etc. or did it also occur in others who ate Aunt Millie’s 3 day old non-refrigerated custard? Such distinctions are important so that potential drug-related side-effects can be clarified. EncounterSuite has a module called Client Expert that allows trial administrators to create questions in an adaptive questionnaire format for the PGMH. Following Trial Protocol
EncounterSuite has several features that would facilitate protocol compliance. Treatment favorites are macros that enable a physician to create a complex set of orders with a single click. The trial administrator can create a Treatment Favorite for each visit, thus ensuring the correct orders are written. All orders remain in EncounterSuite’s Inbox until they are completed. Thus incomplete protocol orders can be identified and followed up. By enabling physicians to run trial protocols through their practice, the protocol orders are subjected to the same practice workflow as any order, staff training on protocol compliance would be less and the likelihood of protocol adherence is increased. Pharmacoepidemiological Data
Since all the content is the same across sites and data is stored in a relational database, powerful pharmacoepidemiological data can be extracted. Centralized Structure Facilitates Trial Administration Since EncounterSuite maintains patients’ medical information and the application programs on a central group of servers, clinical trial administration would be simplified. Changes in trial protocols, data, etc. would be made at one location. Improving Recruitment and Reducing Dropout Most studies have dropout rates of up to 30%. Increasing recruitment rates and decreasing dropout rates would lower trial costs and duration. Since a subject is already n front of a computer, why not exploit this opportunity. Let the subject experience the passion of the researcher. In a video, the clinical trial administrator or researcher can explain about the trial, what is required to participate in the trial, and why the trial is important. Then at various intervals throughout the trial, the administrator can thank the patient for participating and update the patient on the findings, etc. In summary, EncounterSuite has many useful features would facilitate the conduct of clinical trials reducing cost and trial duration. |
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