Decentralized Clinical Trials: Balancing Patient and Site Needs

Decentralized clinical trials (DCTs), including hybrid studies, have become the latest trend in pursuit of more patient-centric trials. Spurred largely by the success of decentralized approaches to many trial activities, including e-consenting and replacing site visits with telehealth visits, as methods for dealing with COVID restrictions, sponsors and sites alike have been touting decentralization and flexible visit options for patients in efforts to highlight their efforts to make clinical research as patient-friendly as possible.

But the full value of DCT methods and technologies may be dependent upon specific patient characteristics and individual site capabilities. Rather than assuming that use of DCT methods is beneficial to all patients, for instance, sponsors and research sites might do better to look closely at their specific patient cohorts to determine what individuals in those groups truly need.

Recent research by the Tufts Center for the Study of Drug Development (CSDD) and Medable has shown that DCTs offer strong ROIs to clinical trial sponsors via shorter development times, reduced screen failure rates and fewer protocol amendments. For instance, the results indicated that a $3.126 million investment could see returns of $17.3 million to $77.8 million.

This alone could provide a strong incentive for sponsors to design trials that include at least some DCT components, such as remote visits, telehealth, mobile apps, wearable devices, and home and local assessments. Additionally, adding decentralized technologies to protocol designs could be seen as an obvious way to tick the “patient centricity” box that is viewed as critical to successful enrollment and retention.

Florence Healthcare said in a February 2022 blog that, as of 2021, 95% of research sites use at least one form of decentralized technology. Meanwhile, professional conferences continue to features sessions about decentralized, hybrid and virtual trials.

And patient reception has been positive, with about 92% of patients indicating they want clinical trials to include some sort of remote feature using innovative technology.

Similarly, results from a survey published in the July 2022 JAMA Network Open indicated that more than 80% of cancer patients and survivors would be willing to use most remote options, such as oral medications delivered to the home, e-consenting and wearable technology.

Listen to patients to achieve patient-centricity

But it’s important to remember that one size does not fit all in terms of patients. In any clinical trial, every individual patient will be unique. Some may not want a home healthcare provider in their house at any time for any reason. Different locations that are nearer to or farther from the research site as well as a given patient’s level of comfort with technology used to assist in fully or partially decentralized trials are other key factors that play a role in whether a patient prefers remote or on-site visits.

In many cases, sponsors may be adopting decentralized features to check a box for patient diversity or increased population diversity, both of which have been touted as benefits of DCTs and hybrid studies. Because this is often done based on an assumption and without consideration of what specific patients say they really want, it’s unclear whether patient-centricity is truly being served.

A July 2022 ObvioHealth article, for instance, listed three reasons why patients may prefer virtual clinical trials. Chief among these was safety, especially with COVID still a lingering threat that many patients may seek to avoid. The second reason was accessibility, especially for patients who live at some distance from clinical sites or otherwise have difficulty getting to a site; this has widely been cited as a major factor driving perceived patient preferences for DCTs. The third reason was flexibility, with reduced or nonexistent site visits, clinical trial participation creates less disruption in patients’ daily lives.

These benefits are thought to boost both patient numbers and diversity among patient populations by helping clinical trial sponsors reach a broader swath of people.

But there is risk in assuming that all patients are going to have the same preferences or face the same pressures. One factor that should not be overlooked is the degree to which many patients value relationships. In fact, the relationship with a trusted provider or a coordinator who led them through a consenting procedure is often the reason why some patients enroll in a clinical trial at all. Shifting from that model to use of varied home health providers and novel technology could turn some patients off from clinical trial participation. 

The use of technologies can also raise concerns. Florence Healthcare noted in its blog that, in addition to losing a sense of connection with physicians, a top patient concern with DCTs revolves around technology learning curves.

To aid with technology use, some sites have added a new position: a patient technology navigator. While it seems a good idea to have a tech specialist available who is well-versed in both teaching and trouble-shooting the technology used in a clinical trial, it remains uncertain how valuable patients find such individuals. There is a tendency among some patients to prefer to have just one or two trusted contacts at a clinical trial for everything.

Sites left out of discussions?

And just as every patient is unique, the same can be said of every research site. Offering patients more choices in how they participate in a clinical trial is generally seen as a patient-centric move. And flexibility can be a plus for many patients. A degree of flexibility can lie within many sites’ capabilities. But it is also possible for a study to be too flexible in what it offers. Too many choices can lead to dissatisfaction, especially if there is variability among site capabilities and patient characteristics at different locations in a multi-site trial.

Sites can have significant variation in staffing and available technology, among other factors that can influence whether a DCT is a good option. Additionally, service providers and their preferences and capabilities must be considered.

As one example, some sites, particularly larger ones, may already have their own home health operations, while others would have to hire third-party providers. This would reduce the opportunity for patients to build close, trusting relationships with coordinators, investigators, nurses and other key study staff.

And if particular technologies are to be used to provide patients some choice between at-home and on-site visits, every site participating in that study needs to have—and be proficient in using—those specific technologies and associated. 

And that means that training in all of those technologies will be required for site employees, which can raise the question of where that training will come from. If a particular vendor provides the technology, that company may provide training, but additional education may be necessary to ensure that research staff understand how to use the technologies and associated systems as specifically needed for an individual protocol. 

That additional training could place additional burdens on frequently overworked staff. If a site must incorporate some decentralized features into a clinical trial, then the sponsor needs to have a plan for teaching both research staff and patients how that will happen. Staff need to be trained in the systems that will be used to communicate with patients and to gather and report data.

Patients, for their parts, must be trained in the use of trial-specific technology, such as e-diaries and wearable devices. While it’s often assumed that study coordinators or other research staff will provide this type of training for patients, that may not be practical. The staffers themselves may lack sufficient proficiency to teach a new user of a technology effectively.

And having individualized training for every piece of technology or new system deployed poses serious challenges. It can be difficult to validate whether staff and/or patients fully understand how to use the technology as needed for the clinical trial, for instance, especially if multiple providers are conducting the training.

A better option might be an all-in-one remote training solution that is designed specifically for conduct of a DCT or hybrid study. And a remote training approach with capacity to provide instant feedback to users can greatly streamline the training experience and thus reduce the time burden on site staff. 

Additionally, troubleshooting technology and data and communication systems for patients is another sure way to add to site workers’ burdens. Even at larger research centers where specific tech support workers may be hired, patients are more likely to call the study coordinator or another research staffer with whom they have built a trusting relationship.

In the spirit of being patient-centric, some of the conversations around full or partial decentralization of clinical trials may have left sites out of the discussion. Sponsors and others making decisions about study designs may lack full understanding about how much goes into preparing a given site to be ready for a DCT or hybrid study. The effort needed both in preparation and during the study can add to staff burden.

To avoid overburdening staff and causing burnout, it’s important to balance what is good for the patient—or at least what sounds good—with what is feasible at the site level. One way of doing this could be for sponsors to map out a day in the life of a site. This would require them gaining a deeper knowledge about what the sites they hire do, which employees are involved, how much time critical and non-critical tasks take and how much time is spent on research- or patient-focused activities versus administrative tasks.

One thing that could be of great help to research sites is a deep dive into how the various systems employees must use interact with each other. Looking at what the staff at the site touches and what the patient touches could be a good guide to which systems would benefit from this type of scrutiny. Use of remote training that tracks learner performance and feeds that information back to sponsors can aid these efforts, showing where skill gaps may lie and helping to highlight which technologies used within a DCT will truly add value, rather than additional burdens, to a study. 

And most importantly, it would help sponsors see whether changes made in the name of patient centricity create more or less of a burden for those sites, as well as how sites may differ in their capabilities.

In short, sponsors should avoid assuming that DCT or hybrid trials are automatically going to meet all patient preferences. At the same time, study designs need to take into consideration the realistic capabilities of the specific sites that will be conducting the research and interacting with the patients.

There is simply too much complexity across too many possible permutations to be able to state with confidence that DCTs are better options for any patients, sites or types of clinical trials.

To learn more about a remote training approach ideal for both sites and patients, please visit the our simulation webpage: http://proficiency1.wpenginepowered.com/simulation-training/

Beth Harper

Beth Harper, Chief Learning Officer at Pro-ficiency, is on a mission to eliminate protocol deviations. Beth brings 35-plus years of experience in clinical research operations to Pro-ficiency, utilizing this knowledge along with her years of creating live protocol simulation training to create cutting-edge simulation training programs at Pro-ficiency. Beth has published and presented extensively in the areas of study feasibility, site selection, patient recruitment, protocol optimization, sponsor/site relationship management and clinical research professional competencies. Beth received her B. S. in Occupational Therapy from the University of Wisconsin and an M.B.A. from the University of Texas.