Using real-world evidence in clinical trials: Challenges and opportunities

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The healthcare industry traditionally has used site-based clinical trials to assess the efficacy and safety of drugs and medical devices. Data collected from participants in these trials would be evaluated to determine whether the product in question should be approved for commercial use.

In recent years, however, the exponential increase in patient data recorded by digital devices has raised the possibility that real-world data (RWD) and real-world evidence (RWE) may be used to augment clinical trial data.  

But what are RWD and RWE? Are they the same thing? And how could they effectively be integrated into clinical trials to produce better outcomes for consumers?

Here’s how the FDA defines RWD and RWE:

Real-world data relate to patient health status and/or the delivery of healthcare routinely collected from a variety of sources. RWD can come from mul…

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Ethics matter when deploying RWD and RWE

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Because adoption of real-world data (RWD) and real-world evidence (RWE) remains at an early stage, individual biopharma executives are likely to take on a central role in ensuring that such data — and the related use of AI — are handled ethically. It becomes imperative that drug developers using RWD ensure transparency, apply consistent rules, peer reviews and develop best practices when dealing with biased research data.

The ethical dimensions of RWD are poised to “become a much bigger topic of conversation,” said Jeff Elton, CEO of ConcertAI, which just hauled in $150 million in Series C funding.

That said, FDA has released a series of guidance documents related to RWD and RWE in recent years with some recommendations for dealing with incomplete data. In essence, the agency stressed studying the representativeness of RWD and, if it is not fully representative of a t…

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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…

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What’s really happening with clinical trial innovation?

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The clinical trial landscape has evolved significantly in the past two years. But given the quick embrace of decentralized clinical trials and growing traction of apps, digital health and other technologies in the space, it can be difficult to separate hype from reality.

To learn more about the evolving landscape, we caught up with Libbi Rickenbacher, director of strategy at 4G Clinical, to discuss the ongoing impact of the pandemic, decentralized clinical trials and other relevant trends.

Radical shifts in clinical trials?

The pandemic has undoubtedly disrupted clinical trials, leading to delays and outright cancellation of scores of studies. It may seem like a radical shift, but there was also self-preservation at work, Rickenbacher said.

“For some of those studies, maybe it was better for them to cancel,” she said. “It was very unfortunate for the patients, but you …

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Why RWD and RWE are poised to continue gaining ground in 2022

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While the present adoption of real-world data (RWD) and real-world evidence (RWE) remains early, such data promise to accelerate regulatory decision-making and support the approval of new indications for drugs already on the market. 

“We’re now seeing real-world data being used and consulted almost 100% of the time to design a protocol for a study,” said Jeff Elton, CEO of ConcertAI. “That was not the case three or four years ago. That’s a pretty fast transition.” 

It also helps that the FDA has also sharpened its focus on RWD and RWE. For example, late last year, the agency published proposed guidance related to data standards for product submissions with RWD. The agency also weighed in on the use of RWD and RWE to support regulatory decision-making for drugs and biological products with specific advice for data from electronic h…

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Harnessing the power of real-world data requires careful consideration

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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…

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