Supporting Staff Through the Transition to Hybrid Studies
Traditional Clinical Trials
Most clinical trials were conducted in person up until the last decade. People who wanted to participate had to travel to a research site for every test and procedure. That could be across the country or their local doctor’s office. Traditional clinical trials are slower, less efficient, and often more expensive than hybrid and fully decentralized trials. Additionally, there are also time and financial barriers for patients, which can lead to a lack of diversity among clinical trial participants. As a result, certain populations may not be accurately represented in the development of a drug or treatment.
The Benefits of Decentralization
Clinical trial sponsors and clinical research organizations (CROs) around the world have adopted digital technologies that allow a decentralized approach to address challenges in recruitment, retention and data capture (1). Decentralized clinical trials take place virtually and are conducted using remote monitoring devices, apps, mobile devices, or online social engagement tools. Decentralization removes barriers to participation by enabling participants to connect with their physicians and care team through telemedicine, allowing them to get tests done at labs near where they live, and having nurses visit participants at their homes.
Decentralization also allows for more people to participate in clinical trials and creates opportunities for a more patient-centric trial design. For ethical, scientific, and regulatory reasons, racial and ethnic diversity are increasingly important to clinical development. A decentralized approach can be part of a program to increase inclusion by decreasing physical and economic barriers to research participation.
What is a Hybrid Clinical Trial?
In hybrid clinical trials, some of the study activities are conducted remotely while others take place in person at traditional clinical study sites. Hybrid trials allow patients to take part in some activities from the comfort of their homes, while also interacting with study staff in person. They allow patients to meet face-to-face with site staff and physicians, yet not often enough to prevent them from participating due to challenges getting to the study site.
How to Support Staff Through the Transition
It’s important to support study staff through the transition to remote trial management. Staff members —including nurses, regulatory coordinators, finance team members, and program managers—are likely working in completely new ways while also supporting patients through new remote procedures. Sponsors and CROs must be trained to use digital technologies such as wearables, eConsent, sensors, and eCOA. Staff should be familiar enough with software and equipment that they can answer any questions that participants may have. Study managers should conduct both in-person and e-communication updates on items like timelines, functionality, and training.
It’s important for clinical trial leaders to remind staff that they are still working with humans, even when they aren’t meeting with trial participants face-to-face. By hearing the patients’ concerns, study leaders can better understand barriers to success and design studies that reflect this understanding. This can result in studies that minimize patient burdens and allow more patients to participate.
Involving patients in the study process from study design through each phase of research gives us insights that we could not possibly get elsewhere. After all, only the patients know all the details of how clinical trial participation impacts their lives. Some considerations that sponsors and study teams should plan for upfront include the digital divide; readiness and availability of devices and connectivity in any given participant population, acceptability of the planned trial design by participants and their caregivers, accessibility and simplicity of user interface (UI) and user experience (UX) design, and consistent use of “people-first” language throughout participant facing materials including trial technologies.
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