CWWeekly presents this biweekly feature as a spotlight on issues that executives in clinical research face. This week, writer Barbara M. Bolten spoke with Adam Butler, senior vice president, Strategic Development and Corporate Marketing, Bracket. Butler is responsible for Bracket’s service offerings in Randomization and Trial Supply Management, Electronic Clinical Outcome Assessments, and Rater Training and Quality Assurance services.
Q: How can mobile applications supplement clinical trial management across the industry?
A: Investigators or study coordinators at clinical trial sites can use mobile apps to perform certain common tasks on a smartphone instead of a work station, and avoid the need to go back and forth between different systems. For example, site professionals responsible for patient randomization can use our RTSM app on their phone while they are sitting with a patient in an exam room or in a dispensary, complete all the IRT data entry, connect with the server and the system will automatically provide an ID for a kit that can be given to the patient. Also, an app can be used to scan the barcode on a specific inventory or kit. That’s a really important safety mechanism that ensures that patients never receive the wrong investigational drug. Bringing everything closer to the patient and making complicated clinical trial processes more efficient are important reasons for developing and using these mobile apps.
We also have a patient diary app that subjects can download onto their own smartphone and use to report data throughout the trial. We ran a study in which patients could choose to either download the app to their smartphone or log in from a web browser on their personal computer. People greatly preferred the mobile app as the mechanism for reporting. By the end of the study, more than two thirds of patients were using the mobile app to submit their data.
Q: How can providers of software for clinical trial logistics and supply chain management integrate their tools to improve the user experience and increase efficiency?
A: We built our eCOA platform on the same framework as our RTSM platform, so there are built-in integration points that allow passive interactions between the two systems. For example, a subject questionnaire done in a screening or a randomization visit can automatically trigger enrollment eligibility or stratification into the randomization system. Also, clinical trial sites only need to log into one portal instead of two—with one username and password. Reports can also be integrated in certain ways; for example, investigators don’t have to duplicate patient screening IDs between systems. Like many other providers are now doing, we support a single sign-on standard that will allow a federated login experience among other service providers that work within the same standard. This approach is becoming more common in the industry, but it has been difficult to implement. Everyone is trying to get there, and it’s going to be a really important shift over the next few years.
We have a site advisory board that is comprised of investigators and study coordinators from clinical trial sites, and we work with them during the design, development and beta testing of our software tools. We allow them to see the screens, the workflow and how the tool would work on a laptop, a smartphone or a tablet. Once the tools have been used in the field for a while, we follow up with these sites to make sure that they are working well and to see how they interact with each other.
Q: What advantages and opportunities do you see for patient engagement and site adoption?
A: Allowing patients to download apps to their own smartphones removes barriers to their participation in a clinical trials. In studies in which patients use their own devices for reporting—and, for example, that use SMS text messaging reminders— compliance and medication adherence can be higher than in traditional studies. I think we are going to see a lot of new approaches in this area—finding ways for patients to interact more directly with the clinical trials—in the next couple of years. A growing body of evidence suggests that when deliberate patient engagement interventions are designed into a clinical trial, we get better data, more data, better patient compliance and patients enjoy the experience more.
Working collaboratively with investigative sites during product development to make sure that tools are going to be helpful is a really important part of increasing adoption. When sites understand how these tools are going to work, and we accept and incorporate their feedback into designing our tools, we get better data when they are put into practice. It’s our job to make using the tools as easy as possible, and to ensure that sites see them as something that’s going to help the clinical trial process, not hold it back.
This article was reprinted from Volume 21, Issue 23, of CWWeekly, a leading clinical research industry newsletter providing expanded analysis on breaking news, study leads, trial results and more. Subscribe »