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Modernizing clinical trials with digital technologies and the cloud

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Modernizing Clinical Trials: Digital Technologies and the Cloud 2 Published by FiercePharma D eveloping and bringing a new drug to market is costly, with estimates ranging from $650 million to $2.9 billion, a 145 percent increase over the last ten years. 1 E xecution of clinical trials is historically the most expensive part of the process, accounting for around two-thirds of total R&D costs 2 , and taking upwards of 10 to 15 years to complete. Factors contributing to these high costs include enrollment of patient cohorts that are not optimal for the trial, unproductive trial sites, low patient engagement and dif ficulty in sharing and analyzing resulting data. The problems begin with the limitations of sponsors' ability to identify patients in the active disease state and determine the best sites to enroll them. By one calculation, around 30% of clinical trial sites never enroll a subject. 3 These unproductive trial sites delay data generation and cause a large amount of wasted ef for t, which contributes to the high cost of drug development. Similarly, once a trial is underway, sponsors need agile tools to incorporate the use of mobile technologies, such as wearables and mobile devices, which could generate a wealth of data while promoting bet ter patient engagement. To compound mat ter s, the dif ficulty associated with sharing, aggregating and analyzing trial data can limit the speed and efficiency of studies at each step in the process. The ef ficient generation of high-quality clinical trial data is critical to success for new therapeutics. Yet, 1 ht tps://w w w.polic cost-to - develop - one -new- drug-is-26 -billion-approval-rate -for- drugs- entering- clinical- de.html 2 ME ASURING THE GLOBAL BIOMEDICAL PULSE The Biopharmaceutical Investment & Competitiveness (BCI) Sur vey – 2015. Available at: ht tps://w w w.pugatch- consilium. com/repor t s/BCI%202015%20 -%20Measuring%20 the%20 Biomedical%20Pulse.pdf. (Accessed: 5th September 2018) 3 Non-Enrolling Sites Come at a Price | Geeks Talk Clinical. Available at: ht tps:// enrolling-sites- come- at-a-price. (Accessed: 5th September 2018) companies continue to struggle with the challenges of enrollment, engagement and data sharing. Against this backdrop, pioneering companies are turning to the AWS Cloud to modernize their clinical trials with the analytic capability to optimize studies by predicting the right patients to enroll, securely coordinating and sharing data and incorporating regulated digital technologies. HOW SCALABLE CAPACITY CAN STREAMLINE TRIAL DEVELOPMENT Companies such as Bristol-Myers Squibb are performing in silico clinical trial simulations using cloud-based high- performance computing (HPC) to help them optimize the design of early-phase trials. Bristol-Myers was able to reduce total analysis time by 98% by running simulations in support of a pediatric phase 1 study on the AWS Cloud instead of their on-premises system. 4 It can be challenging to scale the computational power necessary to run trial simulations on-site, as it ties up resources and causes bottlenecks for other researchers. However, vir tually unlimited HPC resources can be accessed on-demand in the AWS Cloud. "Because of the compute capacity that we're able to derive from AWS, we can now hand out dedicated 4 AWS Case Study: Bristol-Myers Squibb. Amazon Web Ser vices, Inc. Available at: ht tps:// - studies/bristol-myers-squibb/. (Accessed: 11th December 2018)

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