real-world data Archives - Medical Design Sourcing

Alliance with Google Cloud the latest to help Atropos Health bridge the evidence gap in medicine

The Stanford spinout Atropos Health, which taps real-world data to analyze patient outcomes, disease trajectories, treatment effectiveness, is joining forces with Google Cloud. The company had already forged an alliance with AWS to offer its real-world evidence offerings on the AWS Marketplace and join the AWS Partner Network. The company’s core aim is to give physicians access to rapid, high-quality real-world evidence data to inform daily medical decisions.

There are different numbers out there, but only about 20% of daily medical decisions have high-quality evidence behind them,” said Dr. Brigham Hyde, CEO of Atropos. “We call that issue the evidence gap.” While clinical-decision making is a central focus area, Atropos collaborates with life science companies. “We launched officially in pharma about six months ago,” Hyde added.

Compressing RWD generation from months to minutes

Brigham Hyde, Ph.D.

F…

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 …

Tirzepatide beats semaglutide 3-to-1 for weight loss goals in real-world data

A new real-world study (pre-print) is the first to directly compare weight loss outcomes between the popular diabetes medications Lilly’s Mounjaro (tirzepatide) and Novo Nordisk’s Ozempic (semaglutide). The results show Mounjaro users are significantly more likely to achieve meaningful weight loss.

Analyzing data from more than 40,000 patients from a large U.S. health database, the researchers found those taking Mounjaro were nearly three times more likely to lose 10% of their body weight compared to Ozempic users. Additionally, they were also almost twice as likely to lose 5% of their weight, and three times more likely to lose 15%.

Weight Loss Thresholds Comparison google.charts.load('current', {'packages':['corechart']}); google.charts.setOnLoadCallback(drawChart); function drawChart() { var data = google.visualization.arrayToDataTable([ ['Drug', '≥5% Weight Loss', '≥10…

Why linking clinical trials to real-world data is the critical next step for medical device development

Connecting medical device clinical trials to real-world data (RWD) helps demonstrate efficacy, safety and cost-effectiveness.

Mehdi NajafZadeh, Medidata

Medical device and diagnostics manufacturers need to build data linkage into their clinical trial planning today to remove silos and mobilize efficient use of data sources for better clinical evidence generation in the years to come.[Illustration via Adobe Stock]

Medical device and diagnostics manufacturers face mounting pressure from regulators, payors and providers to provide more holistic evidence to demonstrate the efficacy, safety, and cost-effectiveness of their products.

To address these increasing requirements — as well as accelerate study timelines and reduce clinical trial burden — medical device sponsors are seeking innovative solutions. Connecting clinical trials to real-world data (RWD) is an effective approach to capture the information nee…

New study sheds light on Eliquis and Xarelto switching

[Adobe Stock]

For patients with an elevated stroke risk, switching anticoagulant medications could be a health gamble. Those who change from Eliquis (apixaban) to Xarelto (rivaroxaban) could face almost double the risk of stroke or severe bleeding. Conversely, sticking with Eliquis or transitioning from rivaroxaban to Eliquis appears to be a safer option.

Those are key takeaways from a retrospective real-world data study presented at the European Society of Cardiology Congress 2023.

ATHENS Study: New insights into Eliquis and Xarelto switching

The ATHENS study focused on patients with non-valvular atrial fibrillation (NVAF) and used a hazard ratio (HR) to quantify the likelihood of stroke or systemic embolism. Specifically, the HR for increased risk for either condition was 1.99, and for major bleeding, it was 1.80, both indicating a substantially elevated risk.

Eliquis has been the subject of seve…

Verana Health launches Qdata anti-VEGF market tracker for in-depth market analysis

Digital health company Verana Health (San Francisco) has unveiled the Qdata anti-VEGF market tracker. It is their first market tracking Data as a Service (DaaS) product.

Excessive amounts of vascular endothelial growth factor (VEGF) can cause abnormal blood vessel growth in the eyes, which, when untreated, can result in vision loss in patients with retinal diseases. Consequently, anti-VEGF therapies help preserve eyesight for patients with conditions such as age-related macular degeneration and diabetic retinopathy.

Qdata anti-VEGF market tracker supports brand-level analysis

The Qdata anti-VEGF market tracker enables comprehensive brand-level analysis. It also provides direct access to real-world data, according to Sujay Jadhav, Verana Health’s CEO. The service offers accurate and timely insights into product performance and market dynamics.

Sujay Jadhav

Real-world data is drawn from the Ameri…

Breaking down barriers: Prioritizing diversity in clinical trials

[Image courtesy of FDA]

Diversity in clinical trials is crucial for ensuring that new medical treatments are safe and effective for all populations. Last year, the FDA released draft guidance that aims to improve the enrollment of historically underrepresented populations in clinical trials.

Demand is growing for more transparency and diversity in clinical trials, according to Erin Leckrone, senior director of clinical trials at Be The Match BioTherapies. Additionally, a growing number of stakeholders are stepping forward to promote diversity. “The COVID pandemic really amplified a lot of people’s voices in this space,” she said.

A growing number of stakeholders have stepped forward to demand better diversity in clinical trials and to understand “what data is actually collected as part of the clinical trials,” Leckron said. Those players range from regulatory agencies like the FDA to clinical trial …

AI oncology startup ConcertAI raises $150M in Series C funding

Real-world data (RWD) specialist ConcertAI has closed a $150 million Series C funding from the investment firm Sixth Street.

The Cambridge, Massachusetts–based startup has achieved a $1.9 billion valuation.

“Our Series C represents another milestone in our emergence as the leader in accelerating biomedical innovations through AI SaaS clinical trial solutions and improved patient outcomes through the generation of real-world evidence for peer-review publications, regulatory decisions, and clinical interpretation,” said ConcertAI CEO Jeff Elton in a news release.

ConcertAI specializes in analyzing clinical and genomic data as well as conducting RWD analyses for regulatory purposes to inform clinical trial design.

The company has extensive, independent, deep datasets linked to claims data.

The company has alliances with biopharma companies, including Janssen and Bristol Myers Squibb (BMS).

In September 2021, Janssen and ConcertAI deepen…

Harnessing the power of real-world data requires careful consideration

Image courtesy of Pixabay

The use of real-world data (RWD) has boomed during the pandemic, but the pharmaceutical industry has only scratched the surface in terms of tapping its potential.

The use of such data, however, is set to grow, given the FDA’s recent release of new guidance concerning the use of electronic health records and medical claims data for regulatory decision-making for drugs and biologics.

Two years ago, some people in the industry questioned “whether RWD would have any application in the world of clinical development,” said Jeff Elton, CEO of ConcertAI. Those days are over. It is now clear that RWD is important, given the FDA guidance and the surge in use in RWD during the pandemic.

The level of rigor concerning RWD is set to grow, given FDA’s feedback concerning the use of such data in clinical trial designs, trial interpretation. “The expectati…

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…