The patient-centered clinical trial has been a favorite turn of phrase for the pharma and contract research organization industry in the past few years. But the adoption of technologies that allow scientists to build in more flexibility into clinical trial design for these trials will do more to make this a reality than other efforts. The past couple of weeks offer a few examples of how this trend is coming to fruition and accelerating amidst eClinical solutions market projections estimating growth from the current level of $3 billion per year to $5.98 billion per year by 2020.
An electronic clinical outcomes business, Bracket’s acquisition of mProve Health adds technology that enables clinical trial participants to use their own mobile devices and potentially improve communication with patients. Contract research organizations face the same issue as healthcare and other industries the challenge of how companies using legacy software integrate enterprise tools.
Large Electronic Clinical Outcomes Assessment (eCOA) providers have to figure out how to retrofit their systems to support emerging mobile health technologies and BYOD, a news release from Bracket noted.
Adam Butler, Bracket strategic development and corporate marketing officer, said in an email that mProve has been a BYOD device pioneer and has a track record of working with pharma and regulators to make BYOD work in clinical trials.
Also this week, Science 37 completed its first virtual clinical trial, a Phase 2B study for AOBiome. More than 8,000 individuals with mild to moderate acne were screened and 372 were enrolled in the study. Participants could connect with Science 37 dermatology expert investigators using a loaned iPhone and data plan. Science 37’s tools also include video-based telemedicine visits between study staff and patients and a component that gives users the ability for users to take pictures of themselves to transmit to investigators.
It marked the first time a Phase 2B randomized placebo-controlled trial has been successfully done with all participants taking part remotely. AOBiome also had positive efficacy and safety findings from the study, which assessed a topical formulation of a single strain of beneficial AOB, Nitrosomonas eutropha. It’s an interesting development because the company is also about supporting the use of connected devices to enable remote monitoring of clinical trials.
These developments follow the launch of Johnson & Johnson pharma arm Janssen’s remote monitoring product for clinical trials — Integrated SmartTrial and Engagement Platform. Among the components are connected medication blister packs that indicate when patients have taken each pill has been taken. Electronic drug labels make it easier to convey medication information in the participant’s language. Another component, eCommunication, makes it easier to customize information to individual trial participants. Videos and patient notifications can also be transmitted through a smartphone.
Butler said the iSTEP program was an exciting development for the advancement of the mobile clinical trial tech sector.
“We see ourselves operating on an ecosystem, and the commitment J&J has made here is a great step forward.”
Photo: appleuzr Getty Image
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