Mobile Devices Pave the Path for Clinical Research Evolution
Clinical trial sponsors looking to stay at the forefront of efficiency and accuracy should consider whether they are making the best use of the growing trend of access to clinical data on mobile devices. From the secure sharing of electronic patient reported outcome (ePRO) data, to creating more flexible clinical data management, mobile technology has the potential to improve processes across the clinical research process. In many cases, sponsors are already seeing the benefits – including real-time alerting capabilities and increased efficiencies – of incorporating mobile technology in their research process.
Real-time results – delivered to the right people at the right moment
Real-time alerting can dramatically improve a trial’s overall success rate. Alerts can be configured to automatically send an email or text message to a mobile device when a pre-specified event occurs, such as when a serious adverse event (SAE) is entered into the system. It is important that alerts notify mobile devices; most people are not always logged into their computer workstation, but many keep their smartphone or tablet close by. This helps ensure that all relevant stakeholders are informed as quickly as possible when their action is required. For example, if a patient in Sweden reports symptoms via their iPad after intake of Drug X, their information can be instantly analyzed in California, where a data manager will be notified that he or she needs to take appropriate next steps, which may include alerting sites across the globe to suspend the use of Drug X. With the use real-time notifications delivered through mobile devices and the ability to act upon this feedback from any web-enabled device, response times can be reduced from days or weeks to hours or minutes, giving clinical teams the opportunity to address problems before they put a study in jeopardy.
Consumer-based efficiency – taking advantage of familiar technology
Increasing trial efficiency and correctness are common requirements for CROs and trial managers when implementing new clinical trial technologies. Luckily, mobile devices and their efficiency benefits can be easily introduced into the research process without costly hardware investments or extensive user training. Most trial participants and managers currently utilize mobile devices in their everyday life, so the functionality is already available. Because participants are using a technology they already understand, it becomes easy for them to enter data directly. In addition, trial participants will be more likely to engage with tools they’re already familiar with, enabling increased accuracy and improved reporting. And because of the connectivity of mobile devices, it is easy for trial managers to retrieve data from patients without costly delays.
Data security concerns – succeed with caution
In order to make mobile capabilities a research reality, we can’t ignore the possibility of security threats and regulatory concerns. However, mobile software can be very secure if written properly, and the clinical trial industry can benefit from the great strides other industries such as online banking have made in mobile security. Similarly, regulatory concerns can also be addressed by ensuring mobile software is fully Title 21 CFR Part 11 compliance. Data security is a risk in any electronic platform, but when addressed carefully, its risks need not outweigh the vast benefits that electronic technologies provide.
Propelling into a mobile-charged future
As the clinical industry becomes more dependent on technology, waiting for results or data batches to be complete will no longer be acceptable or considered the norm. The ability to increase efficiency, analyze live data and implement results immediately demonstrates collectively the key benefits of utilizing mobile devices in clinical trials. Taking advantage of new and innovative technologies is a key to the future of clinical trials, and mobile capabilities will pave the way.
CEO, Comprehend Systems
Rick Morrison is the co-founder and chief executive officer of Comprehend Systems. Prior to founding Comprehend Systems, Rick served as the chief technology officer of an internet-based data aggregator, where he was responsible for product development and operations. Rick has over a decade of experience writing software for clinical trials, including tools that are now used by the FDA and top pharma. Rick holds a bachelor’s degree in computer science from Carnegie Mellon University.
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