26 July 2008 Imaging and Cardiology Jonathan Goldman ... - ICON plc

Pg 10IVRS systems have been used successfully to speed data capture,randomize study subjects, manage and track clinical supplies andissue reminders and alerts.ePRO (Electronic Patient-Reported Outcomes)Many clinical studies today rely on some form of patient diaries tocollect patient reported outcomes (PRO). PRO can provide vitalendpoint data and are therefore critical components of many trials.Traditionally, these diaries were paper documents – forms thatstudy subjects would fill in manually. However, paper-basedsystems have serious drawbacks:• Labor intensive: Study personnel must collect diaries, processinformation and perform quality checks• Costs of printing and distribution• Patients can lose diaries• Because diaries remain in patients’ hands, errors and omissionsmay not come to light until the end of a studyIn comparison with paper-based PRO, ePRO, which uses Internettechnology for patient data collection and communication, hasseveral advantages.RFID tag. RFID stands for “radio frequencyidentification device.” It’s the same technologythat’s used in credit cards, where a small striprecords unique identification about how you useyour card. Similarly, the eCap can record when amedicine container is opened, thus helping keepa record of patient compliance. RFID technologycan also be used on blister-packs, to recordwhen the seal is broken and a pill is removed.Data WarehousingIntegration of various systems within clinical trials has becomemore common than ever before. EDC systems often requireenrollment data from the IVRS. The IVRS requires site data fromthe CTMS. Each integration is often built on a study specific basisfor each technology vendor. The possibility of errors and datainconsistencies is enormous and the data flow diagrams look like apile of spaghetti. A central data repository, based on CDISC,would allow each vendor to build a reusable data integrationmodule. The data warehouse would allow consistent reportingacross multiple studies. In addition we would be able to reducethe time required to setup these systems in the beginning.http://ecap.biz eCapAdvantages of ePRO• Eliminates problems associated with paper diaries• Greatly increases patient compliance 2• Reminds patients of important study activities (site visits, dosechanges, etc.) with pre-programmed alarms, voice mailmessages or e-mails• Monitors data entry compliance in real time and issuesreminders, thus preventing missed entriesRegulatory agencies today look favorably on ePRO data as itprovides an excellent record of patient activity, and in most casesis more complete and accurate than paper diaries. Indeed, thenumber of clinical trials using ePRO continues to increase, fromapproximately 5% in 2002 to 15% in 2007. 3ePRO as a feasibility toolDropping non-compliant patients from a study is costly – but whatif you could predict in advance which patients would be non-compliantand correct the problem before the study started? Somesponsors are running pre-studies using placebos to learn whatfactors lead to non-compliance. Armed with this information, theycan design appropriate patient education materials, or refineprotocols to weed out subjects likely to be non-compliant. ePROtechnology can be invaluable in speeding up this process.eCapsOne novel use of technology that has recently appeared on thescene is the eCap. An eCap is a medicine bottle cap with a built-inPractical considerationsWhat does all this mean for clinical research professionals? Astechnology grows more powerful and pervasive, we will seesignificant changes in the way clinical trial information is gathered,organized and presented. Regulatory agencies are likely to changetheir requirements to favor new forms and formats for electronicallypresented data. Clinical professionals who can work comfortablyand creatively with technology will have the edge in the industry,making it even more critical to select and implement the mostefficient e-tools.Notes1Paul Bleicher, “The Fully Electronic Office (or Clinical Trial) Myth,”Applied Clinical Trials, October, 20042Stone AA, Shiffman S, Schwartz JE, Broderick JE, Hufford MR.“Patient non-compliance with paper diaries.” Br Med J2002;324:1193-1194.A National Cancer Institute (NCI) study reported that patientcompliance levels for electronic diaries were higher than for paperdiaries. The study also showed a large discrepancy betweencompliance levels reported by patients with paper diaries (90%reported) and their actual levels of compliance (11% actual). Incontrast, actual compliance with electronic diaries was 94%.3Gustafson, Kris, “ePRO – maximizing the benefit and minimizingthe pain,” World Pharmaceutical, April 17, 200844021 US.indd 12 12/1/08 10:20:03 AM