By: Brad Pruitt, M.D., MBA
Executive Director, Chief Medical Officer
The clinical trial industry is going through a digital transformation. Paper-based methods that resulted in low patient engagement and imprecise, slow-moving data are quickly becoming a thing of the past. By 2017 the FDA is mandating electronic submissions as the new standard for drug development. This push for digital trials is helping to improve every aspect of clinical trials while making it easier and more appealing for patients to participate.
Mobile clinical innovations have enabled the industry as a whole to focus on engaging and retaining patients. With the average dropout rate being 30% across all clinical trials, it’s no doubt that clinical trials need to improve patient engagement and retention. Trials that fail to engage patients experience higher dropout rates. In fact, 85% of clinical trials fail to retain patients. Patient retention and engagement is extremely important for the success of the trial. Patients also dropout for different reasons: schedule conflicts, forgetting visits, misunderstood expectations, and lack of appreciation. However, simply going digital can easily prevent most of these occurrences.
Going digital doesn’t only mean reducing the amount of paper that is used in a clinical trial, it also means improving all-around compliance, including the principal investigators (PI), sites, and most importantly, the patients. Maintaining patient compliance is crucial for patient retention and the overall success of the clinical trial. Compliance can be achieved by leveraging everyday technology, such as smartphones and wearable sensors, which help integrate aspects of the clinical trial into the patient’s life and everyday schedule.
Today, technology is used in clinical trials to qualify, consent, enroll and engage patients through a website or mobile device. Once a patient is digitally enrolled, mobile clinical technology further speeds research through digital surveys, on demand videos, patient eDiaries, reminders for medication and appointments, secure video conferencing and the ability to earn badges and rewards based on behavior. The best part is that these activities happen seamlessly through wearable devices and the patient’s own smart phone. It’s no longer a question of how to get the data. Today, the question now is what to do with it. Real-time data means that the clinical trial team has the insight to identify potential risks and to take action before problems arise.
Thanks to innovative mobile clinical technologies, the clinical trial team spends less time and energy gathering data. A comprehensive mClinical platform, like Clinical6, engages, retains and reports everything regarding patients, PI’s and sites. We live in exciting times and the capabilities we discussed today are just the tip of the digital iceberg. How are you going to use mobile clinical technology to transform your clinical trial?