The Changing Clinical Trial Landscape

The Changing Landscape of Clinical Trials

Although the COVID-19 pandemic has caused tremendous trauma and disruption to the healthcare industry, it has also forced much-needed innovation to clinical trials, mainly in the form of virtual participation. Prior to the pandemic, numerous barriers caused clinical trials to be out of reach for most people. For example, according to a 2019 study published in the Journal of the National Cancer Institute, only eight percent of American adult cancer patients participated in clinical trials. The lack of participation appears across all demographics. According to an FDA analysis of clinical trials between 2015 and 2019, only seven percent of African Americans and 13 percent of Hispanics participated in clinical trials during that time.

But, with progress, there’s often at least one setback. One of the bigger hurdles we’re looking at going forward is just how patients can be recruited, given new regulations from social media giant Meta, which owns Facebook and Instagram. Below are some of the ways clinical trials are changing for the better and some of the challenges they face.

Decentralized trials will give participants more convenient monitoring options

The rapid change to virtual workplaces meant researchers had to make a choice: either decentralize their trials to create easier patient access (such as virtual participation) or put their trials on hold. Many, like Florence Healthcare, chose the former. In their 2021 State of Clinical Trial Technology Industry Report, they noted that in 2020, 76 percent of their clinical trials conducted most or all of their patient monitoring remotely, a tremendous increase from the 18 percent in 2019. Florence Healthcare wasn’t alone. As researchers switched to remote data collection, they quickly found that the old standards weren’t as necessary as they thought.

For example, New York’s Northwell Health hospital system conducted its first fully virtual clinical trial in January 2021 and was so pleased by the results that they say it won’t be their last. Without the barrier of on-site visits, the Northwell Health decentralized trial was able to recruit a more diverse set of participants than in its other trials.

Japanese pharmaceutical company Takeda saw similar results in their trials during the pandemic. Because of this, they’ve vowed to change their policies. They recently told technology company Morning Consult that within the next year, 30 percent of their new studies would allow participants to meet with researchers virtually or at trial sites, which are easier to access than medical centers. And, in one year from now, they plan to have that opportunity available for every new study.

Technology will continue to improve decentralized clinical trials

In order to conduct these decentralized trials, researchers relied on technological advancements in a variety of areas, including:

• Artificial intelligence (AI)
• Electronic consent, known as eConsent
• Video conferencing
• Wearable devices, like smartwatches and fitness trackers, to record participants’ vital signs

As more and more trials become decentralized, technology will continue to improve. According to IBM, decentralized trials will work best and increase participant engagement, when technology is designed to be convenient and easy for all participants. For example, they explain that apps can automate reporting from the patient’s devices, allowing investigators to record the time, date, location and type of a medical interaction automatically.

And, as AI continues to improve, so will clinical trial possibilities. For example, during the summer of 2021, Fortune reported that London-based artificial intelligence company DeepMind used AI software to “predict the molecular structure of hundreds of thousands of proteins, including almost all proteins in the human body, and published the findings in a new, freely-accessible public database.”

In a November 2021 interview with Clinical Trials Arena, Wout Brusselaers, the CEO and founder of Deep6 AI, predicted that AI will also help create and test a synthetic population of AI-built patients. In addition, he believes AI will be able to use “real-life patients as a control sample to confirm and guide the digital avatars’ features.”

Recruitment via social media may become more difficult

Social media has proven to be a great method for clinical trial recruitment, but that may become more difficult in 2022. In November 2021, Meta, Facebook’s parent company, announced that beginning in January 2022, they will implement a ban on advertisers who use messages that target patients based on their health conditions.

While the goal of this ban, which came about due to pressure from patient privacy advocates, is to avoid discrimination and micro-targeting of vulnerable groups, this could be bad news for companies that recruit clinical trial participants on their site.

Previously, recruiters could use Facebook to reach individuals who interacted with content related to their study topic. Now they’ll need to be more discreet and target people in a specific region, for example. These new restrictions, according to marketers, will increase their costs and make it more difficult to attract diverse populations.

It’s not yet known whether other social media companies will implement similar policies. Although recruiters will need to adapt to the new policy, it may mean that they’ll need to explore better ways to recruit through doctors and hospitals.

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