Contributed Commentary by Tim Davis, Veeva Systems

August 26, 2022 | How often have you read an article or seen a conference presentation on improving the patient experience during clinical trials? Maybe 10, 20, or 100 times? The scientific community has talked about this topic for over 20 years. Yet, low patient engagement and retention have remained a significant challenge across the clinical trial industry for over a decade. 

A lack of engagement and retention may be due to the industry applying many different patient engagement approaches. A patient participating in a trial might be required to receive notifications, use an electronic patient-reported outcomes (ePRO) diary, and complete questionnaires from multiple applications while also using wearables or electronic concierge services. Adopting countless tools to engage patients and capture information also impacts sponsors and sites that need to learn and use multiple systems to execute processes.  

This approach limits the opportunity to share common learnings, establish standard procedures, or gain economies of scale through replication across studies. Additionally, increased trial cost and complexity create barriers to a more seamless patient experience.  

COVID-19 accelerated the shift to digital clinical research and sped the adoption of remote patient solutions. Digital tools quickly went from desirable to essential so companies could decentralize study processes; however, it has not been a smooth path to mainstream acceptance. The industry is progressing, but there is still more work before patient engagement solutions are a core component of trial design and delivery. What are the challenges ahead, and how can we address them?  

Fragmented Systems Increase Complexity and Delay Data Availability   

The use of disconnected technologies drives concerns around the lack of interoperability across clinical systems. Sponsors and CROs often say the rapid adoption of stand-alone solutions for decentralized trials led to inefficient internal workflows and challenges with collaboration and getting information in and out of systems. Clinical trials with disjointed systems result in added time, cost, and quality issues.  

For example, ePRO is a pivotal component of patient-centric trials, but it is often fraught with high costs and complex use protocols. The lack of consistency across trials further complicates the configuration, testing, and rollout of ePRO. 

When using a stand-alone ePRO application for patient-reported outcomes, sites must manually enter metadata (i.e., patient ID, visit schedule, study phase, etc.). This process can be error-prone, requiring additional data management resources to crosscheck the information. Patient data must be transferred from the ePRO database to another system before achieving a meaningful, holistic review. This end-of-study work is a pain point and stark example of the consequence of disjointed approaches to clinical trials, where strict procedures are followed to protect data integrity and security.  

In practice, end-of-study media is often shared via password-protected USB thumb drives or CD-ROMs. With modern laptops not including CD-ROM drives, ePRO vendors must provide external hard drives to the sponsor. This provision requires study teams to jump through hoops to access the information and comply with security and privacy policies.  

Although ePRO generates more complex data than other solutions such as eConsent or messaging, the same principles apply. It is no wonder that study teams are reluctant to add new technologies to their trials. An integrated platform that enables end-to-end connection between patient technology, the site interface, and sponsor systems would streamline this process, reduce human error, and ensure real-time data is available within the right systems.  

Put Yourself in the End User's Position  

The adoption of engagement solutions stems from a desire to reduce the burden on patients, but how often do we consider their experience holistically? It is easy to think of all the aspects of a trial separately because we understand each process' purpose.  

For patients, each engagement is simply part of the trial, and using multiple applications is confusing and unnecessary. Participants can be required to download as many as five apps during a clinical trial which is overwhelming and certainly not patient-centric.  

The consumer space offers valuable lessons for clinical research since people usually download apps and can use them intuitively. Very rarely is the help section needed, and users do not have to complete training to gain value. Of course, we should not abandon support altogether, but making it easy for patients to use clinical trial technology is critical. Site staff already have enough on their plate without acting as IT help desks.  

Since sites may be using multiple systems across their portfolio of studies, offering a more streamlined way of working could significantly speed execution. Site-facing interfaces should be straightforward so staff can start using applications quickly with minimal support.  

As an industry, let us take a step back and consider how these solutions can be leveraged without adding a burden on sites or patients. Companies must start moving away from using multiple technologies that create siloed processes, shifting focus toward developing a single platform of connected systems. This shift can deliver a consistent patient and site experience while enabling a more seamless way to exchange information across study stakeholders.  

When it Comes to Patient Engagement, Less is More 

Technology advances opportunities to improve clinical trial experiences. Engagement solutions no longer focus on reminding patients to take their medication or complete a diary through smartphones. Instead, systems incorporate site communications, concierge services, and transportation applications such as Uber. This transition adds complexity for all stakeholders: study teams, sites, and patients.  

To make the transition smoother, companies can standardize processes and reduce study-by-study customization by developing core, scalable strategies to enhance the patient experience across their trial portfolio. Although there may be individual trials where a targeted approach is needed, like in rare disease studies, standardizing an engagement strategy is key to driving patient-centricity without overburdening sites or study teams.  

With standardized processes and workflows, sponsors can reduce implementation complexity and create a repeatable model across most studies with minor changes based on trial requirements. Connectivity is also key to ensuring information flows seamlessly across systems and should be built into the strategy. Connectivity will improve data quality and remove downstream pain points associated with extracting information from siloed systems.  

More consistency across sponsor studies will also benefit sites by requiring fewer systems and reducing the administrative burden. Sponsors can then automate information exchange to facilitate faster data analysis and uncover broader study trends.  

A standard and connected approach will make it easier to broadly incorporate patient engagement solutions into trials while providing site consistency. But most importantly, patients will get the support they need to have a seamless trial experience.  

Tim Davis has over 25 years of experience working with pharmaceutical companies, CROs, and technology vendors in the life sciences industry. He is Vice President of Strategy for MyVeeva for Patients at Veeva Systems. Tim’s primary focus is on the strategic development of Veeva’s patient-facing application suite. He can be reached at tim.davis@veeva.com.