Life Science Leader Magazine Supplements

CRO Supplement 2015

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13 LIFESCIENCELEADER.COM THE CRO LEADERSHIP AWARDS 2015 What technology-related trend do you feel will have the biggest impact on clinical trials in the coming years? ABBE STEEL: When Apple recently launched ResearchKit, unleashing the open-source platform and allowing the makers of apps and wearable devices to tap into the capabilities of the iPhone's wide range of inherent sensors, they opened the door for wearable devices to have a greater impact on clinical trials. The ability to gather data passively, only requiring the patient to wear the device, will mean a greater capacity for insight. At the same time, recruitment and reten- tion should be boosted significantly by the convenience and unobtrusive nature of this type of data collection. The trend toward instant access to real-time data could have a far-reaching impact on clinical trials over the next few years. Studies that incorporate some type of wearable technology that provides a constant data stream may result in faster analysis and data elements we don't currently collect. JOE KIM: There's no question that patient enrollment in clinical trials is one of the top industry-wide challenges. As Abbe mentioned, technologies that help improve awareness of clinical trials and connectivity between patients and clinical trials are on the rise, and I'm hopeful that they will ultimately enable patients to enroll in clinical trials more efficiently. We're specifically looking at engaging ePatients, or patients who are well-informed and empowered by digital technology and see themselves as equal partners with their doctors and health- care providers. We are evaluating what ePatients need and want from their digi- tal experience in order to improve clinical research in forums such as clinical trial matching services and online communi- ties/social media. Ultimately, ePatients are on their way to becoming more of the norm rather than the exception, and by mobilizing this community, we can empower ePatients to have a significant impact on enrollment, study participa- tion, design, and more. DAVE BORBAS: Tablets, data integration between systems, and smartphone tech- nology. Tablets and smartphones are common devices across the world and are extremely familiar to users. That means patients, research center teams, and physicians are comfortable with these technologies and will expect good performance from them. Training that is generalized will be a diminishing need, and training will only be needed on the study applications. These technologies have Wi-Fi and cellular connectivity built in and will enable a wide-area use for research protocols. On the database back end, integration between systems means that once data is entered it will be available in multiple systems. This decreases the need to rec- oncile data between them and provides the users common data for basic sub- ject information like demographics, ID numbers, and other types of test results like labs, questionnaires, and ECGs. This means more correct data shared across systems, and it will be more quickly avail- able. TIM DAVIS: I certainly agree with all of what has already been said. Mobile solu- tions are ideally placed to address the challenges that today's clinical studies pose and are now being implemented as a means of communicating directly with patients across broad demographics and multiple widespread geographic locations in clinical trials. From enhancing adherence and retention through to the collection of time-stamped and authenti- cated PRO (Patient Reported Outcomes) data, mobile solutions enable each trial to be designed to include a relevant, stan- dardized, and tailored communication plan. Patients can therefore be prompted to take medication, record data, and attend site visits. Additionally, through the inclusion of timely and relevant educational and motivational messages, they can be better engaged throughout the duration of the study. J O E K I M Senior advisor, clinical innovation at Eli Lilly A B B E S T E E L Founder and CEO, HealthiVibe T I M D A V I S CEO and founder, Exco InTouch D A V E B O R B A S Senior director, data management at Jazz Pharmaceuticals

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