BUILDING BETTER CLINICAL TRIALS

Genentech's Digital Health team helps others implement novel technologies into clinical trials using CTTI's Digital Health Technologies recommendations and resources. Here, the team explains why the recommendations are such an asset and how others can use the recommendations as a starting point for their digital efforts. 

Digital technologies offer the potential to increase the quality and efficiency of clinical trials-- from reducing barriers to participation and improving the participant experience, to capturing more informative real-world data and lowering costs associated with conducting clinical trials. But with technology moving at near-lightening speed and little known about potential research participant preferences related to the use of digital technology, incorporating these devices into the design and conduct of a trial can be tricky. One member of Genentech's Digital Health team (part of Genentech's Research and Early Development (gRED) group) helped CTTI develop comprehensive recommendations to help stakeholders implement digital tech into trials more effectively. Once those recommendations were released, Genentech set out to implement the guidance across the own organization. 

Interest in digital health technology (also referred to as mobile technologies) is high across the industry, with stakeholders realizing the merit and enhanced insights these solutions can offer. Genentech, a large biotech organization, was eager to implement mobile solutions quickly, but without a formal structure in place for integrating these technologies into Genentech trials, they had to essentially build the ship and sail it at the same time. In addition, with technology constantly changing, the organization had to implement a plan for mobile tech that was durable, but also not too specific. 

With one member of Genentech's Digital Health team having served as a co-author on CTTI's recommendations for industry on the use of digital tools in clinical trials, Genentech had a knowledgeable resource to disseminate the guidance across the organization and use it to help build out the company's plan for integrating digital health tech into its research efforts.

Numerous colleagues at Genentech were interested in this effort, and the Genentech Digital Health team advised them all similarly on how to begin based on CTTI's recommendations: determine what you want to measure. A challenge with digital health tech is that there is always a shiny, new product that "promises the moon". However, for Genentech's studies (and most clinical studies) the team was not looking to track hundreds of data-points simultaneously. Genentech's Digital Health team urged its colleagues to first establish a hypothesis on what they want to measure, and then use this information to select a solid, reliable tracker to collect data to support that measure. For example, for overall activity tracking, the Digital Health team uses the Actigraph Centerpoint Insights watch to capture their Moderate-to-Vigorous Physical Activity (MVPA) endpoint. It is better, the team says, to use a reliable streamlined device than a new one that might utilize multiple sensors beyond the accelerometer, but brings potential risk because the device isn't proven and the extra data may not be helpful. Genentech's Digital Health team also launched a plan to use CTTI's recommendations in a way that gave all of its colleagues a common "language" around mobile tech. Words like "validation" and "verification" can have different meanings across organizations, bringing confusion to the mobile technology integration process. CTTI's recommendations offer a common voice that ensures everyone is speaking the same language.

The Digital Health team originally planned on six months to implement its CTTI-inspired mobile tech evaluation infrastructure at Genentech, but the project took more than three years and is still being refined. This, the team says, reflects the complexity and scope of Genentech as well as the rapid pace of technology development. The organization is selective about the studies in which it chooses to deploy mobile tech, so results are limited. However, interest across the company in the Digital Health team's guidance is constantly increasing, suggesting the effort's success and ultimate impact will be substantial.

Mobile technology is one of those topics that makes biotech both excited and nervous at the same time. Excited because the opportunities are massive; but nervous because this is an industry that is generally hesitant to change and take on any perceived risks. According to Genentech's Digital Health team, the thing to remember is that digital technology is the way forward, so the real risk is in failing to develop an internal method to evaluate options that can both safeguard and enhance study outcomes. The team views CTTI's recommendations as a solid starting point to begin to bring digital tech on board in the right way at the right time for your trial.