Technology to support decentralized clinical trials has been developing for several years, but the COVID-19 pandemic pushed decentralized trial use into high gear. Rapid development of decentralized trial methods in 2020 and 2021 has provided a wealth of information — much of it promising. Many clinical trial teams were able to collect at least some data remotely, reducing the burden on patients.
Decentralized trials introduce new technologies to address the challenges of running a clinical trial without a single, centralized trial site. Some of these challenges are unique to decentralized trials. Other challenges exist in both centralized and decentralized trials.
One challenge common to all clinical trials is to coordinate the roles and needs of various stakeholders. Understanding these roles and needs is a must.
Identifying Stakeholder Roles and Needs
Fully centralized trials focus on a single research site, such as an academic medical center. All trial procedures are conducted on-site.
Decentralization of a clinical trial decouples some or all trial procedures and data-gathering from the central trial site. In a hybrid trial, patient participants may perform some trial procedures on their own or visit mobile or satellite sites. In a fully decentralized trial, patient participants rely on digital tools to stay connected to trial teams as they carry out procedures on their own.
Not all clinical trials are good candidates for decentralization. Many can function in a hybrid format, write Gaurav Agrawal and fellow researchers at McKinsey, although hybrid and decentralized trials introduce new complexities.
Clinical trials bring together patients and professionals from a wide range of fields. The diverse nature of stakeholders guarantees a variety of perspectives and concerns. When a trial is decentralized, balancing stakeholders’ complex needs becomes more challenging.
Most decentralized trials involve several stakeholders. Stakeholder groups common to most decentralized trials include:
- Trial sponsors.
- Patient participants.
- Technology and service partners.
Each group of stakeholders participates in a decentralized trial in order to achieve certain goals. Trial sponsors and investigators seek to develop data to support hypotheses and push drug development forward. Regulators seek evidence of safety and efficacy. Patients hope for improved treatment of their medical conditions. Technology and service partners look for ways to streamline and improve clinical trial processes.
Clinical trials, decentralized and otherwise, face both new and lingering problems. Recent drops in clinical trial participation make research challenging. Among patients who still participate, non-white populations remain underrepresented: About 76 percent of all clinical trial participants worldwide are white. Only about 11 percent are of Asian descent and only about 7 percent are of African descent — even though Black people and African Americans constitute 13.4 percent of the population, writes Raolat Abdulai, global clinical lead at Sanofi, citing a 2020 FDA report.
Technology cannot solve this problem alone, but a clearer understanding of barriers and challenges in the decentralized trial process can help teams implement technology effectively.
Understanding and Aligning Roles and Needs
Each stakeholder group in a decentralized clinical trial has certain responsibilities, write Amir Kalali and Craig Lipset in STAT News. Sponsors, for example, must produce valid, reliable scientific evidence. Investigators also play a key role in study execution and safety. Regulators rely on sponsors’ and investigators’ efforts, as the data generated in a clinical trial forms a basis for regulatory decision-making.
Some clinical trial participants bear certain burdens related to their roles, the authors note. When decentralized trial tools create more complexity, investigators may find themselves swamped in extra busy work, hampering their ability to focus on the trial itself. Patient participants may be asked to engage with new technologies or gather more data without actually receiving greater access or control. While technology and service partners attempt to support decentralized trials, lack of information about existing challenges can hinder their efforts.
Some stakeholder burdens are shared. In a 2021 article published in the Journal of Medical Internet Research, Romée Melanie Helena Coert and fellow researchers surveyed various clinical trial stakeholders, including staff members at research organizations, pharmaceutical companies and food companies.
They found that many of the survey respondents named similar barriers to the adoption of decentralized virtual clinical trials. These included:
- Compliance and adherence.
- Technical issues, including standardization, validation, and data storage.
- Regulatory challenges.
- Lack of knowledge or understanding.
The researchers also found several common features that could break down these barriers and facilitate better trials, such as:
- Including regulators in the trial development process.
- Using the results of pilot studies to inform decision-making.
- Communicating clearly with patients and providing patient assistance.
Identifying roles, goals, and potential burdens is an essential first step toward better stakeholder inclusion in the decentralized trial process. Early incorporation of stakeholders in the process also may lead to better results.
How the Right Tools Help Coordinate Stakeholders
Early incorporation of diverse stakeholder viewpoints offers an early opportunity to identify challenges as well as common ground.
“When considering the implementation of decentralized components to optimize clinical trial design, it is important to engage with all stakeholders early in the protocol design process,” write Maria Apostolaros and fellow researchers. Sites of engagement in the early stages include:
- Meetings with regulatory agencies and representatives.
- Communication with prospective patients to better understand their perspectives.
- Working with experienced vendors.
Throughout the clinical trial development process, teams can take steps to better understand stakeholders’ roles, goals, and concerns. Information collected and shared allows all stakeholders to find better solutions to key problems.
In a 2022 study published in the British Journal of Clinical Pharmacology, Joanne Coyle and fellow researchers interviewed various stakeholders in remote decentralized clinical trials (RDCTs). They found that successful RDCTs had various themes in common:
- Involving patients in identifying research questions helped to boost engagement and participation.
- Recruitment materials, apps, and websites offered ways to build patient recruitment and retention.
- Ongoing feedback for patient participants helped patients stay engaged.
Patients weren’t the only focus for successful RDCTs. The researchers found that early engagement with trial partners allowed for better relationship-building. Furthermore, many teams believed data completeness was easier to obtain when several modes of capturing data were used — including methods that engaged patients directly.
Coyle, et al. also found, however, that decentralized clinical trial teams needed to pay attention to how workloads were distributed when technologies were used. They noted that “RDCTs may transfer trial activity burden onto participants and remote-working research staff,” especially in the gathering of data.
The COVID-19 pandemic hastened the adoption of decentralized clinical trials. During the first year of the pandemic, 32 percent of clinical trials switched to a virtual footing, write Jason Evers, Jennifer Rowan and Jackie Flanagan at Bain & Co.
Digitally-based decentralized clinical trials offer new ways for researchers to harness data. Still, they also pose new challenges for stakeholders. When stakeholders’ diverse roles, goals, and frustrations are aired early in the process, trial teams can select technology and processes that streamline the clinical trial and reduce frustration.
As with other technologies, digital tools to support decentralized trials won’t bring stakeholders together or solve problems on their own. When problems are understood first, teams can choose technology that addresses the issues they have — without creating new ones.
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