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Wearables and Mobile Technologies Growth Opportunities in Digital Transformation Journey of Clinical Trials
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Clinical trial sponsors and clinical research organizations (CROs) are facing intense pressure to change the way clinical research is conducted and justify the costs and time involved in the clinical development process. Some of the prevailing challenges in the clinical trial industry include the complexity and cost of conducting clinical trials, the failure of trials, increasing regulatory requirements for future targeted therapeutics, and the growing number of multi-regional and international trials. Among these, patient recruitment and monitoring activities are considered to be most cost and time-consuming aspect of the clinical trial process. Industry estimates suggest that about 80% of pharmaceutical clinical trials do not meet enrolment deadlines, resulting in an average loss of up to $1.3 million per day for a given drug candidate. Additionally, up to 37% of research sites fail to meet their enrolment targets, and 10% fail to even recruit a single patient for the study.Digitization is playing a critical role in transforming clinical trials model from traditional (centralized) high-cost and difficult-to-access settings to more patient-centric and efficient virtual models. In particular, pharmaceutical companies are seeking to leverage mHealth solutions—embracing digital technologies such as wearables, smartphone Apps, and cloud-based remote/virtual clinical trial platform solutions—for improving patient engagement, preventing trial failures, and, overall, improving the drug development profitability. Early application of wearable devices and smartphone apps across remote or virtual clinical trial designs demonstrate compelling benefits around optimizing the patient recruitment process by opening up new geographies to increase access to the larger patient population and reduce trial costs by streamlining the trial processes and demonstrating real-world efficacy. Digital e-Recruitment solutions leveraging mHealth technologies and innovative crowdsourcing models promise to drive efficiency and optimize the patient enrichment strategy for future patient-centric clinical trials. This, in turn, would help to improve patient engagement with autonomous and digital workflows (e.g., eConsenting, remote monitoring, virtual training, and reminders) that reduce the burden on the patient and the caregiver. Furthermore, based on research findings, clinical trials industry participants across North America and Europe will continue to the major markets for mHealth technologies application in the clinical trial industry by 2020. Easy access and convenience factors offered by mHealth-enabled remote trials could significantly reduce patients’ travel cost to the sites as they could now participate from their homes using computers and smartphones, eventually improving retention. mHealth technologies provide new possibilities to capture objective digital biomarker data, increase the reporting quality of clinical trials, and reduce SDV by eliminating errors due to with traditional paper-based reporting by patients or investigators.
The research service analyzes the growth opportunities of mHealth technologies across clinical trial remote patient recruitment & monitoring applications. It also evaluates and discusses market projections, key trends, technology lifecycle, and the key implementation challenges of emerging digital solutions. Finally, it provides industry best practices, case studies, cost-benefit analysis, and strategic imperatives for key clinical trial industry stakeholders such as pharma sponsors, CRO, sites, and technology providers.
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