Digital Innovation in Enhancing Clinical Trials

Like so many other aspects of the pharmaceutical industry, digital tools, platforms and processes are transforming clinical trials in dramatic ways. This includes recruiting and engaging patients, streamlining data management, enhancing overall stakeholder communications and coordinating investigators and investigator sites.   As digital innovation continues to accelerate, new opportunities will arise that improve the clinical trials process even further. Faced with this wave of innovation, teams need to develop systematic processes for evaluating new technologies, and determine if and how these technologies can help to streamline their particular trial experience. When innovatively applied, these new technologies can benefit study sponsors, investigator site staff, subjects and their care-givers.   Protocol Development Process   First of all, the protocol development process itself is an area where technology has promising potential. By building collaborative tools and platforms, clinical teams can effectively break down silos across the organization and streamline the process of gaining input from a broader range of internal and external stakeholders. This input ensures that the protocol is effective both in terms of final outcomes, as well as in the day-to-day logistics of trial execution. These real-time collaboration tools also have the potential to reduce costly and time consuming amendments.   Once the protocol is initiated, the investigator meeting itself can dramatically benefit from the strategic use of technology. Infographics and tablets can make it easier for investigators and their staff to understand study protocols, while interactive displays and virtual simulations can help to reinforce key aspects of the study design. These tools help investigators find better suited subjects, and also help equip them to respond to issues to improve completion and retention rates.   Digital Tools to Enhance Trial Experience   As the investigators return back to their respective study sites, digital tools can also help transform the subject onboarding process, making it easier for subjects to understand informed consent and help to set realistic expectations around the overall trial experience. Once patients are enrolled in a well-designed study, another area that is particularly rich for tech-driven innovation revolves around behavior modification and patient compliance. Motivation can be difficult to generate on its own, but if technology is aligned with the patient’s existing motivations and predispositions, then the trial processes can make it easier for patients to do what they are already inclined to do, thereby improving retention.   Social Platforms and Technologies   With the rise of powerful social networks and smartphones, technology can also be used to enhance the patient recruitment process, helping to geo-target around key study centers, while also providing digitally based infographics and videos that can easily be shared across various social platforms.   Risk-based monitoring, driven by Big Data analytics, is a digital endeavor at its core, with data streams that can be supplemented by digital tools, such as real-time chat/live video chat, and artificial intelligence algorithms which can help study sponsors anticipate and quickly identify issues before subject drop-off.   Voice activation, powered by devices like Amazon Echo and Apple Siri, combined with distributed sensors, also hold promise for providing a framework of in-home compliance, patient support and real-time contact with both the local study site, as well as national sponsor representatives.   As technology continues to accelerate, there will be countless opportunities to improve all aspects of the clinical trial process. In this environment, trial teams need to consider technology trends, but more importantly - focus on patient care and behavior change – systematically applying the appropriate technologies that will drive a successful trial for sponsors, investigators and patients alike.   By Ken Fabianovicz, Director of Commercial Strategy & Innovation at Cadient, a Cognizant Company