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BOSTON, Mass. – March 16, 2015 – Anytime, anywhere access to information, whether for study patients, investigative sites or sponsors of clinical research is critical, but innovations across mHealth and elsewhere remain conceptual until they’re in the hands of the people who need them. BBK Worldwide, a leading clinical trial marketing firm removes a key barrier – cost – by announcing the availability of My Clinical Study Buddy® for patients and My Protocol PalSM for investigators free of charge throughout 2015. By derisking innovative mHealth strategies, BBK aims to fuel adoption to benefit the clinical research industry.
“Recent technology news has categorized the clinical R&D industry as lackluster with regard to patient engagement innovation citing printed flyers as the foremost tool used to reach out to patients,” said Joan F. Bachenheimer, founding principal of BBK Worldwide. “And while it’s true that the industry has been slow to adopt technology in key engagement areas, innovation in mHealth has quickly evolved in the last two years with the industry advocating for, seeking, and deploying app, online, and text solutions to motivate clinical trial participation and awareness.”
My Clinical Study Buddyoffers patients a HIPAA compliant, secure environment where a study participant can retrieve regulatory-approved information and messaging while tracking appointments and preparing for study visits. Designed around a patented security system that unlocks the app only for the study patient or his/her caregiver, the app offers several key features: “Visit Planner,” which includes visit descriptions so patients know what to expect for each visit, a calendar managing reminders and visits, and links to office locations and maps; “Study Resources,” which includes educational resources, articles and related videos; and “Study Contacts,” which offers direct access to site staff.
My Protocol Palhelps ensure that the study is always top of mind, that the right information is in the right hands at all times, and that ultimately, enrollment goals are met. The app keeps sites and study teams informed with the latest, regulatory-approved protocols, improved prescreening and site-polling features, tools for evaluation and training, and patient materials, all to remove the complexity and cost associated with outdated processes. For example, a lack of site training and/or ineffective training related materials has a big impact on enrollment rates. Materials lacking proper ethics approvals can derail a study completely – devastating to the site, the sponsor and the patients they are committed to help.
Additionally, through new data streams available through the app, sponsors can see how sites are performing, which sites might need improved engagement and/or additional materials, and are alerted to issues like a low pre-screening numbers, which if not addressed quickly will have a major impact on the study as a whole. As a result, sponsors can make adjustments as needed immediately; often minor corrections that can have a dramatic impact on the sites and the study.
Moving mHealth for Clinical Trials Forward
BBK’s mobile apps are built on its cloud-based content management engine, TrialCentralNetSM (TCN®), to help companies reduce enrollment timelines and provide insight into key patient recruitment pressure points. What’s more, BBK’s engagement solutions, RSG® Card and RSG® Arrive are also available through TCN for a seamless connection to My Clinical Study Buddy. These offerings allow the study community to more easily reimburse and arrange travel for relevant studies, a major and often overlooked bottleneck for sites and sponsors – especially with the complex travel and reimbursements inherent in rare disease trials.
“Wearables and apps for observational studies initiated by physicians are important but not the same as an app needed to help a patient make an informed decision to participate in a sponsor-initiated investigational drug study where there is a 25 percent or more chance of receiving placebo,” continued Bachenheimer. “Both types of apps are needed, but they solve very different problems for very different subsets of clinical R&D.”
“We must continue to innovate in this space to deliver companies what they need to enroll trials more quickly and efficiently, and give patients the tools and data they deserve as study participants,” said Matt Kibby, BBK principal and Technology and Innovation lead. “In very short order, mobile is becoming the new baseline.”
Available for Apple® and Android™ mobile phones and tablets, both My Clinical Study Buddy for patients and My Protocol Pal for investigators are available on the App StoreSM and Google Play™. Contact BBK at firstname.lastname@example.org to learn more.