clinical trial diversity Archives - Medical Design Sourcing

Inside Amgen’s ATOMIC strategy to use ML to accelerate clinical trials

[Image credit: Amgen]

Amgen has developed a machine learning platform to slash clinical trial times through smarter site selection. Known as ATOMIC, short for Analytical Trial Optimization Module, the system crunches disparate datasets to predict optimal trial locations, expedite enrollment and trial processes. Early results indicate more than a two times increase in enrollment speed at ATOMIC sites.

ML-powered clinical trial oracle could compress clinical trial cycle time

“With the massive amounts of data we’re pulling from various sources, we anticipate that by 2030, we’ll be able to shave about two years off the development times for our drugs,” said Sheryl Jacobs, vice president, global Development operations at Amgen. For now, the company is steadily ramping up the number of trials using the ATOMIC process. “Within the next year or two, we expect the majority of our trials will be using the AI …

A current perspective on machine learning’s role in advancing clinical trials diversity

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The year 2020 was a watershed moment for many reasons, but notably, it cast a light on the pervasive health and social inequities that have long marred the U.S. The COVID-19 pandemic hit diverse populations disproportionately hard, as Deloitte and others have noted. Additionally, the tragic deaths of George Floyd, Breonna Taylor and others provoked an uproar over systemic racism that permeates society, including healthcare. This period of societal upheaval has also underscored the necessity of novel approaches involving techniques like the use of machine learning in clinical trials, to ensure that diverse populations are represented.

Such disparities in healthcare were further highlighted when Moderna, soon to become a critical player in the vaccine race, faced a glaring revelation in late 2020. Only 24% of participants in their phase 3 study were from communities of color, despit…

How the pandemic and George Floyd made clinical trial diversity a priority

[Image courtesy of Chad Davis via Flickr]

Where would clinical trial diversity be without the COVID-19 pandemic and the death of George Floyd on May 25, 2020? It likely wouldn’t be the priority it is today across the industry, according to Ariel Katz, CEO and co-founder of H1, a New York–based healthcare and data analytics platform firm.

After the death of George Floyd, scores of pharma companies created or beefed up departments related to diversity and inclusion. “Basically, every pharma company and biotech is now doing something around diversity and inclusion and social determinants of health,” Katz said.

On Google, interest in the search phrase ‘clinical trial diversity’ surged from July 2020 to July 2021. Interest in the phrase continues to remain strong but has dipped from its peak.

Things have changed considerably during the pandemic.

Walgreens announces clinical trial offerings

The drug store giant Walgreens (Nasdaq:WBA) has launched a clinical trial business aimed at optimizing patient experience, recruitment and clinical trial diversity.

Deerfield, Illinois–headquartered Walgreens will offer both in-person and virtual care clinical trial options.

In a press release, Walgreens underscored FDA’s push to improve racial and ethnic diversity in clinical studies. In 2020, three-fourths of clinical trial volunteers were white, and only 11% were Hispanic, while fewer than 10% were Black and Asian, according to FDA.

Walgreens intends to use pharmacy and patient-authorized clinical data to match diverse patient populations to clinical trials in an array of disease areas using race, gender, socioeconomic status and location data.

Walgreens also promises to help drug developers improve patient recruitment and enrollment in clinical trials. The company operates almost 9,000 stores. More than half of them are based in socially vulne…

Laying the groundwork for clinical trial diversity

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The COVID-19 pandemic has elevated the importance of clinical trial diversity while also asserting remote clinical trials as a valid approach for a growing number of drug studies, as a recent JAMA study concluded.

At the same time, the pandemic highlighted the need for continued progress, according to Otis Johnson, chief diversity, inclusion and sustainability officer at Clario.

“I think COVID shone too much of a bright light on the lack of diversity in clinical trials for us not to make progress,” Johnson said.

More regulatory clarity

While a growing number of drug developers are prioritizing diversity, “regulatory agencies will need to be more deliberate,” Johnson added. “So far, the guidance has been exactly that — guidance.” Regulatory agencies should mandate best practices supporting diversity in clinical trials, he said.

ConcertAI and Janssen deepen data-science collaboration

A multi-year partnership between Janssen Research & Development (NYSE: JNJ) and ConcertAI (Cambridge, Mass.) will focus on using real-world data and AI for oncology applications involving multiple cancer types.

ConcertAI will work “almost an extension of [Janssen’s] R&D development process,” said Jeff Elton, CEO of the company. The two companies’ teams will work closely together with ConcertAI providing data, technology and clinical data scientists.

The two companies began working together in late 2019 and have since partnered on a number of programs, some of which progressed to the clinic, regulatory submissions and regulatory approvals.

Elton said that the recent collaboration is “a major expansion of what we first put into place in 2019.”

ConcertAI and Janssen are also working together to support clinical trial diversity. “We’ve been using some specialized data sets to ensure that clinical trials didn’t unwittingly exclude certain racia…