Excerpted from PMLive.com,

There is increasing interest in digital trials, that is the use of mHealth and mobile technology to capture insights outside the traditional clinical setting. The drivers are clear – spiralling costs, questions with respect to existing endpoints and inability to recruit or retain subjects. The pharmaceutical industry spent over four times more on research and development in 2015 than in 1995, with no corresponding increase in the number of drugs approved by the Food and Drug Administration (FDA). An analysis of trials in 2011 found that 19% of trials closed or terminated failed to meet accrual goals (85% of expected enrolment) or were terminated early due to insufficient accrual.

Summary

Declining research and development (R&D) efficiency is one of the biggest challenges the pharmaceutical industry is facing today. The traditional approach of three discrete, fixed-trial phases designed for testing mass-market drugs often is not viable in today’s increasingly competitive, value-based therapeutic markets. It lacks the flexibility, analytic power and speed required to develop complex new therapies targeting smaller and often heterogeneous patient populations. As a consequence, clinical trials are changing. Digital disruption in the form of new wearables, sensors and medical devices enable pharmaceutical and medical device companies to generate new types of data sets. Artificial Intelligence and machine learning can generate new insights and digital biomarkers that have the potential to be more clinically responsive to change. The successful roll-out of study requires a flexible operational model and experienced study teams that understand device logistics and management, and that have robust digital platforms to train and engage patients and site staff. Skilled data management teams that can process data sourced from diverse systems can be daunting. Experienced patient engagement teams are an essential part of ensuring successful digital studies.

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