n oft-quoted benefit of hybrid studies and decentralized clinical trials (DCTs) is that they increase recruitment and retention by making it easier for people to take part. A global survey of more than 11,000 trial participants found travel was a top participation burden. The same survey revealed ways to relieve study participation burden, which can include making study visits virtual, reducing travel times and distances, and allowing at-home visits from medical staff.

Overcoming the barrier of burdensome site visits has the potential to reduce the dropout rates, particularly among diverse participant populations, that can lead to loss of data. For example, participants from lower socio-economic backgrounds are more likely to struggle with the hidden costs of traditional clinical trial participation like travel, the need for extra childcare, and loss of income.

However clinical trial participants and their caregivers are not data points. They are people who may have varied needs and preferences.

The complexity of participants’ needs within clinical research highlights the opportunities of DCTs and their associated technologies. If not used appropriately, the remote technology and mobile health services that make hybrid and DCTs possible can weaken the link between a participant and the investigative team – the link that can form the very bedrock of participant engagement. As such, it can have the opposite of its intended effect. Conversely, if used appropriately they can increase communication and enable greater patient and caregiver choice, ultimately increasing participant retention and improving data quality.

To truly overcome the Rubik’s Cube of challenges facing the pharmaceutical industry, which require a flexible approach to ensure that the synchronous features of clinical trials are working in harmony, we must combine technological innovation with the human touch.

The Tension

DCTs and hybrid trials have become a central component of the quest for participant-centric research. Worldwide, there was a 50% increase in global drug trials with a DCT or virtual element from 2020 to 2021 and a 28% increase from 2021 to 2022.

Even though COVID-19 forced industry’s hand, there is now widespread recognition that clinical trials need to recruit and retain diverse populations. Lower-income participants are consistently less likely to participate in clinical trials and, historically, only 17% of study participants at any given time across all therapeutic areas have been people of color.

By untethering recruitment from physical site locations, hybrid and DCT models can diversify participation and reduce historical participant burdens caused, for example, by travel complexities and their associated costs. This in turn can improve participant experience leading to higher participant retention rates and reduced loss of important data.

However, adopting remote and hybrid models does not necessarily result in increased diversity. In 2020, when many trials were forced to adopt remote measures, participants of black ethnicity accounted for 21% of COVID-19 deaths but only 3% of enrollees in vaccine trials in the US. While the correlation between these two figures has not been fully investigated, it does serve to highlight the industry’s need to ensure greater representation in their studies.

Although there are multiple barriers to participation, a key factor within some minority groups is a historic, deep-rooted mistrust of healthcare systems and clinical research. Positive relationships with site staff can help to overcome some of these barriers, building trust, keeping participants and their caregivers engaged in a trial, and ensuring they know they are valued partners in research.

The need to build this trust was demonstrated by a standardized Research Participant Perception Survey distributed to 18,890 research participants at 15 U.S.-based clinical research centers. The research by Kost et al. found 86% of respondents trust their research team completely. Of those, 79% were treated as valued partners, 93% were listened to carefully by investigators, and 95% were listened to by research coordinators.

However, analyses of racial and ethnic subgroups revealed that white participants had a higher level of trust in the research team — 88% giving the highest rating — than the four nonwhite groups, in which 78% to 82% gave the highest trust rating.

Traditionally, this all-important relationship is built during visits to the study clinic or site. Replacing these visits with remote data collection and mobile health, then, can impede efforts to build rapport and trust, thereby contributing to lower retention. With participant dropout rates already substantial – sometimes more than 30% in phase 3 – the industry can ill-afford to lose further valuable data.

The expansion of technology deployed in DCTs and hybrid trials, such as recording data via mobile apps, also has the potential to raise digital exclusion challenges. In 2022, 24 million Americans lacked access to high-speed internet, and many more could not connect due to gaps in digital equity, digital literacy issues, and prohibitive costs. It is vital that digital transformation does not further entrench existing representativeness issues in the clinical trial landscape.

These tensions between the opportunities of tech-focused remote approaches and personalized, nuanced care demonstrate the complex issues currently facing the pharmaceutical industry.

The Solution

Technology that is flexible enough to enable participant and caregiver choice, and home health services that replicate the site/participant relationship in the patient’s own home, are crucial to overcoming these tensions.

Regulators have made it clear that DCT design, including the choice of which elements to decentralize, should be informed by participant preference. Industry must collaborate with participants to ensure that protocols are realistic and practical, technology is easy to use, and data collection is as seamless as possible.

It is also worth noting that a survey of people living with rare diseases found that a hybrid approach, rather than an exclusively site-based or decentralized approach, was most favored. Patients who were concerned about fully remote approaches cited possible adverse reactions without specialists there to help them and struggling to comprehend trial literature as key concerns. Home health services that dispatch specialized healthcare professionals to patients’ homes can help assuage these concerns. Ensuring that participants see the same doctor or nurse each time also helps them to build a relationship with them.

A clinical trial may be an unfamiliar experience for participants and caregivers. It can be made more so with the use of data-capture devices and other new technologies. We need to ensure that trial participants and their caregivers receive the information and education they need to use every technology with which they are asked to engage.

In 2021, FDA published new guidance outlining how participants enrolled in decentralized and hybrid trials should possess the education, language skills, and technical aptitude needed to manage the technology they are being given and to use it in a way that will generate accurate metrics. This support should continue throughout the course of a trial.

To overcome fears about adverse reactions, home health solutions should focus on providing the same level of participant experience expected in traditional sites. This includes recruiting highly qualified healthcare professionals experienced in the delivery of DCTs. Home health can be further enhanced by adopting advancements such as wearables that help healthcare professionals take readings and record the data to improve collection, and consequently the value of those data and the services provided through home health initiatives.

Data as a service, connecting all those involved in the successful running of a clinical trial, is where the value lies. The most impactful products will be those with application programming interfaces (APIs) connecting different technologies in a way that is easy for researchers, healthcare professionals, and most importantly, participants and their caregivers to use.

Together these solutions can enhance participant and caregiver experience, improve site efficiency, and increase data quality for system-wide benefits.

Case Study

Seamless technology that integrates the various aspects of clinical trial participation while still maintaining the human touch does exist.

For example, a participant might prefer to travel to a site for some, or all, their appointments. But median non-medical monthly out-of-pocket costs, such as travel, childcare and lost income, are almost $1,000 for clinical trial participants. Use of advanced travel concierge services can provide comfortable, stress-free journeys ensuring that participants are not having to pay for expensive flights for themselves and their caregivers. Financial burdens can be further reduced using expense payment apps and flexible reimbursement solutions.

Centralized technology platforms that underpin and connect all services can be used to ensure home health teams have all the information they need to answer questions and provide updates. Technology can also enable conversations between the site, participant, caregiver, and home health teams, increasing a sense of connection even in a predominantly or partly virtual environment.

In a complex hybrid study exploring treatment of rare muscle disorders, in-depth mobile screening visits in patients’ homes removed the need for patients to travel thousands of miles just to determine eligibility. Because it was a rare disease, healthcare practitioners involved in home visits required specific training, but regular communication and feedback between the team, site, sponsor, patients, and nurses enabled successful completion of screening visits within the required time frame. Once treatment was complete, home visits were scheduled for follow-up appointments with sites joining via a secure video platform. Every patient who attended the clinic reported a positive experience and said they were happy they had participated.

In a survey by patient experience network Raremark, using technology to communicate with staff was listed as a benefit of decentralized trials by 50% of rare disease patients. It was the third most popular benefit after having assessments at, or closer to, home and receiving medication at, or closer to, home. At times when site staff are unavailable to provide reassurance, participants can be further supported through services like 24-hour support lines.

However, to fully realize the potential of these solutions, the pharmaceutical industry needs cross-sector collaboration between sites and providers. We must avoid miscommunication, for example between central laboratories and home health teams, and ensure people do not feel out of the loop however they choose to participate in a trial.

Conclusion

Data and digital technology must first and foremost serve people – not just the participants but all stakeholders in clinical trials. Decentralized and hybrid trials offer huge opportunities to widen participation and improve our understanding of treatment safety and efficacy.

Traditionally, the human touch has been the bedrock of success in clinical trials. By enabling flexible approaches within technology that center greater patient and caregiver choice, meaningful communication and consider the complexity of participant needs, the human touch can be enhanced, rather than replaced, ensuring it remains the firm foundation of our success.

A successful revolution in how participants, caregivers, sponsors, sites, and healthcare professionals connect relies on the utilization of flexible technology and home health services that replicate the human touch of traditional on-site clinical trials. This approach will enhance data quality and improve retention, addressing the Rubik’s Cube of issues facing the pharmaceutical industry, which can help to unleash the evolution of clinical research.