While increased adoption of Decentralized Clinical Trials (DCTs) in the industry carries high expectations for reduced trial burden and faster startup, it also presents challenges around trial complexity, regulatory requirements, and study-level integrations.
 
DCTs, studies conducted leveraging a range of digital technologies to collect safety and efficacy data from study participants, usually from the patient’s home, are less dependent on traditional research facilities. Tools such as sensory-based technologies and wearable medical devices are used along with home visits and the delivery of study drugs and materials directly to patients’ homes. In a fully decentralized clinical trial, subject recruitment, delivery and administration of study medicine, and acquisition of trial data do not involve in-person contact between the study team and the patient/subject.
 
Jill Sommerville, Senior Director, Digital & Decentralized Services, PPD Clinical Research, Thermo Fisher Scientific, discusses the biggest challenges with the adoption of decentralized clinical trials (DCTs) and how the implementation of DCTs might evolve in 2023. 
 
Contract Pharma: As the industry adopts more decentralized clinical trials (DCTs), what have been the biggest challenges or struggles to implement these types of trials? 

Jill Sommerville: Decentralized, digital and remote trials are becoming the new norm. In a recent survey conducted on behalf of the PPD clinical research business of Thermo Fisher Scientific of more than 150 decision-making leaders at pharmaceutical and biotech companies across the globe, more than 30% of the respondents shared that they are currently using these approaches. So, it’s not surprising that DCT stakeholders – patients, sites, sponsors, etc. – all have high expectations when decentralization occurs in trials, each anticipating reduced burden, simplification, faster startup and much more. DCT vendors offer specialized operational teams to help drive a smoother and faster implementation process, while technology capabilities and solutions are more out-of-the-box and require less customization, which results in fewer issues and faster deployments. 

However, that doesn’t mean there are not challenges. Some examples include:

• Regulatory landscape – As we virtualize more, registration processes for decentralized products often require the use of an email (or other personal identifying information [PII]), which is a challenge in some countries and can prevent inclusion of that country or require “clunky” operational workarounds. More technology companies offer configurable solutions versus historic customized solutions allowing faster setup. However, regulatory dependencies, such as screen reports of patient-facing material, still drive the overall project timeline.
• Complexity of trials – Can lead to a complex interaction of data sources from different DCT vendor solutions and potentially multiple operational teams, which can lead to longer startup times and increased cost. 
• Remoteness – The more remote we become, the more challenges our industry faces, such as registering patients without the need for personal identifiers and driving engagement remotely, all of which must be done with sufficient patient attribution and within strict data privacy and security regulations. 
• Study-level integrations/analytics – These efforts can take a long time to develop during the setup of a trial and often still require some manual entry or cross checking.

• A similar range of trials within the DCT spectrum, although the number of DCT elements will increase, potentially leading to more vendors in a single study. 
• An increased number of trials with single sign-on and also non-PII registration capabilities released by technology companies.
• More strategic (up front and planned) integrations between different DCT vendors and real-time convergence of data that will allow for multiple users (home nurses, raters, clinicians, etc.) operating in different locations to easily flow from consent to enrollment to electronic clinical outcome assessments to dashboards and so forth. Greater automation also means single dashboards will be able to better monitor and report project health and compliance.