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Q&A: How electronic data capture is changing clinical trials
A common issue with clinical trials is patient compliance—or rather, the lack thereof. Trial participants who don’t follow their treatment regimens or who fail to properly log personal data tracking their responses to treatment can make accurate data collection and assessment difficult, if not skew it. In addition, the sheer numbers of participants required in most trials to show statistically significant results create an excess of paperwork.
Electronic clinical outcome assessments (eCOAs) offer a more streamlined approach to data management when it comes to patient- and clinician-reported outcomes. As the field grows and begins to adopt “wearable” tech such as smartwatches or activity trackers, including apps that can sync with personal devices, the amount and types of data trial leaders can collect—and the regularity with which they can collect it—all increase and allow for more accurate results. eCOA’s cousin, randomization and trial supply management (RTSM), helps to make the process easier and faster on the part of clinicians and trial sites.
Adam Butler, senior vice president of strategic development and corporate marketing at Bracket, a clinical trial technology and specialty services provider, took some time to give us a brief overview of this market and its impact.
DDNews: To begin with, what benefits does eCOA offer, both for the organizations leading clinical trials and for the patients participating in them?
Adam Butler: There are three stakeholders to consider when evaluating the benefits of eCOA: sponsor companies, clinical trial centers and patients. For sponsors, the evidence is clear that eCOA contributes to higher-quality data, more timely acquisition of data and less missing data. When eCOA is implemented in a thoughtful and deliberate way, investigators benefit because diary and symptom reporting from their patients becomes more reliable, and the use of eCOA at clinical trial sites reduces the burden of paper reporting for coordinators and site staff. For patients, a well-designed ePRO [electronic patient reported outcomes] system is easier to use than a paper diary.
DDNews: How much increased adoption of eCOA and RTSM technology has Bracket seen in the last decade?
Butler: RTSM is a very well-established technology, used in nearly all Phase 2 and 3 clinical trials, and many Phase 1 and Phase 4 clinical trials, even those without patient randomization. But eCOA is still an emerging technology. At Bracket, we’ve seen a rapid increase in how this technology is being adopted, especially in Phase 3 clinical trials. Independent research suggests that the eCOA market is growing about 20 percent per year, and that growth rate is expected to continue through at least 2020.
DDNews: What are some of the mobile applications being introduced for clinical trials, and what needs do they fill?
Butler: Bracket has a mobile suite with apps for all three stakeholders. Our BYOD Bracket Patient Diary has been used in numerous clinical trials in the U.S., Europe and now Asia-Pacific. This app, which is downloaded to a patient’s own phone, allows them to report symptoms and track medication. For sites, our Bracket RTSM app allows most drug dispensation and tracking activities to happen from a smartphone or tablet. We also offer Bracket Analytics, which allows sponsors to track progress of their study on a site and protocol basis.
DDNews: Where does Bracket see this technology going in the future?
Butler: The product roadmap at Bracket is focused on developing new technologies for both sites and patients to better track and report their data. For example, the use of wearable technology is emerging as a useful clinical trial tool. You’re also likely to see new analytical and database tools that allow us to harness more of this data, and provide meaningful insights to pharmaceutical sponsors based on the data that is being collected.
Adam Butler is responsible for strategic development and marketing activities for Bracket’s service offerings in randomization and trial supply management, electronic clinical outcome assessments and rater training and quality assurance services. He has 12 years of experience working in the pharmaceutical services industry. Prior to his work with Bracket, he worked in enterprise software development for firms including Hewlett-Packard, Bluestone Software and Fahrenheit 450.