Traditional vs. Remote vs. Hybrid Clinical Trials: What You Need to Know
In addition to categorizing clinical trials by phase and by purpose, there are also different ways in which clinical trials can be conducted, including traditionally, or in person, as well as remotely via telemedicine or using a hybrid approach of remote and in person.
Before getting into traditional, remote, and hybrid clinical trials and what each one entails, let’s back up and recap the most common types of studies. First, trials can vary based on the objective, or what researchers are trying to find out. For example, treatment studies are designed to understand the effects of new medicines or devices, while observational trialsare intended to understand more about patients living with a particular health condition.
Studies are also categorized by phase, depending on where an intervention is at in the research process. For instance, Phase 1 trials represent the first step of research that includes human participants, while Phase 4 trials are conducted after a treatment is already approved.
Thanks to advances in digital technology and telemedicine, there are now more options for how — and where — clinical trials are conducted.
Remote clinical trials take place in a virtual environment with participants joining by using mobile phones, computers, or other devices. Traditional clinical trials, on the other hand, take place in person at a research site. And hybrid clinical trials usually involve a combination of remote and in-person participation.
Let’s dive deeper into what’s involved in traditional, remote, and hybrid clinical trials.
Differences among traditional, remote, and hybrid clinical trials
Traditional clinical trials
Up until the past decade, all clinical trials were conducted in person. Volunteers who wanted to take part had to travel to a research site, wherever it was located, whether at their local doctor’s office or across the country. These are called traditional clinical trials.
In a 2019 paper, “Virtual Clinical Trials: Challenges and Opportunities: Proceedings of a Workshop” published by The National Academies Press, researchers at the National Academy of Sciences, Engineering, and Medicine explain some of the main limitations of traditional clinical trials. In particular, these studies:
- Are slower, more expensive, and less efficient.
- Create time and financial barriers to participation for patients.
- Limit participation and take longer to enroll and complete.
- Contribute to a lack of diversity among clinical trial participants.
For many patients who otherwise might be interested in participating, they may be unable to get enough time away from caregiving or work responsibilities or have the means or ability to travel to take part. In addition, these barriers can contribute to a lack of diversity among trial participants, who may not fully reflect the spectrum of patients with a particular condition in terms of age, gender, race, ethnicity, and other factors.
Remote clinical trials
Remote clinical trials, or studies conducted virtually using mobile devices, apps, remote monitoring devices, or online social engagement platforms, remove some barriers to participation by enabling study volunteers to connect with researchers and healthcare professionals via telemedicine, having nurses visit patients at their homes, and allowing patients to travel to local labs near where they live, instead of having to visit a study site. The advantage of these trials, which are also known as virtual clinical trials or decentralized clinical trials, include:
- Offering greater convenience and a more inclusive study design for participants, especially those who have mobility challenges, live in rural areas away from study sites, or have other barriers to traveling to participate.
- Increasing the number of participants who can join studies and stay enrolled for the duration of the trial.
- The ability to monitor participants’ health on an ongoing basis, instead of only on-site, offering a more accurate picture of participants’ health information.
- Streamlining the process of developing and approving new treatments.
- Creating opportunities for a more patient-centered clinical trial design.
As the researchers at the National Academy of Sciences, Engineering, and Medicine note, these remote studies can also include some risks and downsides, including:
- Patient information-sharing concerns, regarding the transfer of patient health information via the internet.
- Technical difficulties using the apps or platforms required to participate in the study.
- A lack of in-person communication with healthcare providers.
Hybrid clinical trials
With hybrid clinical trials, some of the study activities are conducted remotely using mobile phones, wearables, or other devices, while others take place in person at traditional study sites.
The benefits of hybrid trials include allowing participants to take part in some study activities remotely while also having the chance to interact with study staff in person.
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