Though all global industries are facing new pressures in light of COVID-19, the pharma and biotech sectors are feeling the pressure acutely — especially in the clinical trial space. For example, according to the WCG COVID-19 Trial Tracker, even with more recent reopening of sites in certain geographies, only 25% are currently open for enrolling patients.
The industry has been slowly moving toward virtual (or remote or decentralized) trials in the last few years. Actually, that is understated when you consider that Pfizer first conducted a remote clinical trial in 2011. Now we find ourselves in the midst of a global health emergency while also facing pressure from the current patent cliff. Together, these forces are driving an accelerated move to virtual trials.
Is now the time for pharma to embraces changes and moves rapidly to virtual trials? What will that take?
Transformation Requires Focus
Yes, pharma can be slow to change, but pharma is also an industry that recognizes the importance of specialization and partners. You can see this mindset playing out now with the emergence in recent years of service providers focused specifically on helping pharma enable virtual trials.
As the COVID-19 epidemic reveals the viability of remote work, the prospect of virtual trials looks more promising. Data collected remotely can be transmitted directly, and securely, to investigators. While this likely will not eliminate the need for occasional in-person intervention or scale, it does minimize the need and moves us closer to meeting the patient where they are. Applications and devices can be custom-configured, and remotely managed, in short time frames to speed things along and help control costs. In other words, remote device and app control and monitoring provide a means to simplify and accelerate trials, despite a trend of increasing complexity in trial design
The advantages of remote clinical trials provide a strong incentive to master these technical and logistical challenges. Most companies in the industry do not have the expertise in-house to launch and manage virtual clinical trials. The question is whether to build this expertise in-house or partner with a specialized service provider.
A Device Management Partner is Essential
Managing the mobile devices required for virtual trials is a difficult challenge that requires specific expertise. Pools of phones, tablets and wearables must be procured, imaged, secured and supported. At study end, those devices can be collected and recycled or wiped and reimaged for another trial if so desired. These logistics capabilities are core to DMI’s continued recognition as an industry leader. More importantly, given the pace of advancement in mobile technology, we can advise you on the best fit for the purpose of your trial design.
As a top mobile device management provider, DMI offers a full lifecycle of services. When trial subjects or investigators have questions, we can provide 24/7 support to make sure they get answers and minimize impacts on the ongoing trial.
Our focus on Agile deployment processes ensures rapid speed-to-value, and our experience in highly regulated industries means we are experts in a full breadth of compliance issues. For nearly 20 years, DMI has specialized in device management for the federal government and many industries, including pharma. Currently, we have over 2.6 million devices under management globally.
Are you transitioning from discussion to implementation of virtual trials? If so, you will encounter many areas of complexity; device management need not be one of those. DMI can engage in discussions with you and demonstrate how our expertise can quickly become your advantage.
— Joel Spittal, industry general manager, life sciences