In a post-COVID-19 landscape, pharmaceutical and biotech companies, regulators and other key research and development stakeholders recognize more than ever the importance of addressing barriers to patients’ participation in clinical trials. This means diving deep into the physical, emotional, logistical and financial considerations that play a role in one’s interest in trial participation and ongoing engagement.
 
The increased use of decentralized clinical trial components in recent years has helped effectively engage patients and address their needs, which in turn has helped reduce recruitment time, screening failure rates and dropout rates. Given these benefits, there has been a significant focus on further integrating the patient voice into trial design and incorporating DCT solutions accordingly. However, it is unclear whether the industry has truly factored in how DCT components, whether technologies or mobile health capabilities, impact site teams. As the industry works to further optimize trials with DCT solutions, it is vital that sponsors and clinical research organization partners continue to consider how to elevate site support in their overarching efforts to enhance patient centricity in R&D. 
 
Below we discuss several ways sponsors and CROs can ensure site needs are prioritized as well. 
 
DCT technology integration, use and support  
DCT technologies, such as eConsent, telehealth and connected devices, are just a sample of the breadth of tech-enabled solutions that can be integrated at sites to aid with trial onboarding, engagement, data collection, etc. Site staff may have multiple platforms to log into and access for one trial’s activities. As such, sites are noting the need for improved interoperability among study technology to ensure better-connected DCT workflows and related data collections so they can meet trial responsibilities and ensure high quality data processing. 

Early planning for optimized data flow and support 
When planning and designing trials, sponsors, CROs and study teams should take a comprehensive look at the end-to-end trial journey and map data flow needs for each stage of the trial and related activities. Then, stakeholders can select specific DCT technologies that help meet trial needs and improve points of friction within the data flow while also accounting for the need to streamline use and connections. 
 
Early in design planning, sponsors, CROs and study teams can ask: 

• What is the best approach to route data flow from prescreening and trial matching phases through eConsent, screening, patient status updates and completion?  

          o Where is data originating, flowing to and ending up?

• What are the risks involved in the data flow and related use of DCT solutions? 
• What are the potential issues patients or sites may experience with this approach? 
• Given the DCT technologies considered, what are the risks to site performance, and will site team training be required? 
• What would this data flow look like if site(s) use their own technologies (i.e., eConsent) for parts of the journey? 

When sponsors select multiple technology partners and integrations may not be feasible, site support and planning for site training will help ensure clinical data activities are set up successfully from the start. 
 
Adjustments per site feedback 
To ensure that sites are truly partners in the process, sponsors and CROs should also keep lines of communication open to secure feedback on what is or isn’t working well within the spectrum of DCT technologies and services being used. For example, intuitive cloud-based DCT platforms are helping to effectively coordinate research and workflows to support patient, site and study team communication and capture all study activity, including visit coordination and remote data monitoring. However, as with any technology, fine-tuning for optimized use can be key. Sites have shared feedback on what platform features are specifically helpful, including allowing patients to confirm provider visits and being able to gauge participant status and televisit use by study (when running multiple studies for a sponsor). 
 
Throughout a study, ensuring sites and patients have a trusted resource to troubleshoot technologies and provide ongoing maintenance will be key to providing the support needed to keep undue burdens at bay and ultimately, optimize digitized trials. 
 
Holistic external support 
When considering the many DCT components that could be included in a trial, sponsors need to consider that having too many cooks in the kitchen may create a disjointed approach to both strategy and workflow that adversely impacts site teams and ultimately, patients. 
 
It could be helpful to work with an external partner who has applicable experience with diverse DCT solutions and support for patients and sites and also has a broad catalog of these components. Imagine the intricacies and challenges that could arise if a trial included the following DCT components and a different partner managed each one: 

• Online patient prescreening, recruitment, consent and onboarding. 
• Remote monitoring. 
• Televisits.
• Electronic clinical outcome assessments. 
• Home-health nursing and phlebotomy services. 
• Patient concierges. 
• Self-collection of blood samples. 

It can be difficult for site teams to navigate various technologies and services they have little-to-no experience with, especially if they have to work with multiple vendors for training, maintenance and ongoing support or if traditional roles and responsibilities change. For example, allowing patients to provide a specimen for lab testing from their home without visiting the trial site or having a health professional visit them may improve their experience and engagement, but site personnel remain accountable for specimen collection. The site’s traditional role collecting, processing, packaging and shipping samples to the lab shifts to the patient, who is educated and trained during the initial site visit or subsequent telehealth visits. This also means sponsors need to ensure site personnel are properly trained to order self-collection kits to be sent to the site or directly to patients. 
 
The move from traditional roles to DCT solutions requires planning, operational workflows and communication to be as seamless as possible for all involved. 
 
Evolving DCT solutions in real time 
As we build upon our collective industry experiences with DCT innovations, we have a tremendous opportunity to finesse what works well to reduce patient barriers to participation without adding to sites’ burdens. It is key to leverage what we’ve learned and establish best practices to enhance DCT solutions and make an even stronger impact on patient engagement and retention while keeping in mind how site models will evolve and require support to deliver a more personalized trial experience. 

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