Table of Contents

1. Why Medicine Needs Decentralized Trial Opportunities
2. The Benefits of Decentralized Trial Implementation
3. How Decentralized Trials Solution Create a Diverse, Hybrid Environment

Clinical trials have long been managed in-office. Specialized clinics and research facilities required patients to come to them for their safety and the integrity of the trial itself. However, when COVID-19 hit, the pandemic required clinicians and regulatory bodies to make a rapid change to continue holding trials while protecting everyone's safety and security.

Today, in-person trials are no longer the only option. Decentralized trials, which occur in hybrid or remote scenarios, make it easier to conduct trials across multiple clinics or medical facilities, between clinics and patients' homes, and in other settings.

Though decentralized trials can be complicated, they are valuable and open up many new opportunities for patients and clinicians.

Why Medicine Needs Decentralized Trial Opportunities

Medicine needs decentralized trial opportunities to enhance accessibility across regions or globally. Additionally, with enhanced accessibility, there is room for more diversity in trials, which can encourage more well-rounded medical care for all.

In decentralized trials, participants can participate remotely. Remote trials reduce patients' stress, encourage better adherence, and reduce the burden of traveling to a trial's location. Additionally, decentralized trials can make it easier to keep patients enrolled since they can complete their check-ins no matter where they are.

The Benefits of Decentralized Trials Implementation

When COVID-19 rampaged through the United States, clinical trials were largely postponed. Bringing people together within a clinic for a trial was a risk; exposing clinicians or their patients to the pandemic was not something most organizations wanted to do.

With the need to continue clinical trials regardless of the pandemic, technological specialists got busy. They, along with regulatory bodies and clinicians, worked out how to create trials with hybrid (meaning in-person and virtual) or fully virtual options. Statistics show that in just two months, 30% of clinical trials had moved to remote or virtual settings.

COVID-19 was a catalyst for many such changes in telemedicine, with decentralized trials being one area in which the pandemic provoked change. The push for change was already needed, though, and that innovation now allows trials to better serve the medical community and its patients.

Opportunities Created Through Decentralized Trials

Decentralized trials create opportunities in several ways that are beneficial to the field of medicine.

First, decentralized clinical trials don't require a local research clinic or trial location. As a result, they can take place in rural areas or regions without those facilities.

Next, decentralized trials have the potential for greater diversity because they provide more opportunities regionally. These trials aren't limited to prospective patients who are local to the facility or who can afford to travel there. Instead, they can occur virtually, allowing nearly anyone who fits the requirements set by the research team to participate.

Another benefit of decentralized trial use is an increase in flexibility during trials. For example, instead of patients checking in with their clinicians every week, the use of wearable, ingestible, or implantable devices allows data to be collected around the clock. In some trials, participants may only call in on occasion to check in with their clinicians via telehealth while their devices report back all the necessary data to track their health and wellness.

It's necessary to emphasize how decentralized trials are often beneficial for keeping patients engaged and enrolled in those trials. Participants:

• Don't have to travel to reach a clinic that is far from them
• Can check in over the phone or a video call when they have questions
• Have wearable or insertable devices that don't require regular, invasive checkups that could cause them to miss work or other activities

Additionally, decentralized trials tend to have speedier recruitment thanks to being open to people from a much wider range of locations. For instance, if a clinic in Ohio was running a trial on people with asthma, it may only get local participants in a traditional trial.

Why? Those participants would need to drive to the clinic, check in with their providers, go through manual testing at those facilities as needed, and so on.

Decentralized trials relieve patients of that pressure while expanding the number of people who can participate. With digital tools such as wearable pulse oximeters, it would be simple to see if someone with asthma had a dip in their blood oxygen levels. Similarly, with telehealth calls, clinicians could ask participants to perform certain self-tests, such as spirometry, at home and note the outcome.

Following such decentralization, it's much easier to build up a list of participants with the exact conditions that need to be involved in the trial, even if they're several states away or outside the country. Therefore, trials can fill up faster and begin to gather much-needed data sooner.

How Decentralized Trial Solutions Create a Diverse, Hybrid Environment

Overall, decentralized trials create diverse hybrid or virtual environments where clinicians have access to a broader population of potential participants. On top of that, trials that are decentralized create an opportunity for greater flexibility in times when patients cannot come into the office. They have opened up new pathways for collecting data, such as by using wearable medical technology devices.

Decentralized trials, then, are one option for continuing research without boundaries. Are you interested in learning more about how to advance clinical trials through intelligent workflows? Visit us today at Studypages.