Featured Editorial
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FDA Releases Draft Guidance On Decentralized Clinical Trials
5/18/2023
The FDA has released a new draft guidance, Decentralized Clinical Trials for Drugs, Biological Products, and Devices. Check out the key takeaways related to remote trial visits, digital health technologies, and more. The public comment period ends August 1, 2023.
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Patient-Powered AI Is Driving Science And Innovation Forward
5/17/2023
Drug discovery is a game of information: If we understand disease well, we know where to intervene and how to design a molecule to target the disease. AI can be used to integrate the patient experience and voice into solutions, further enhancing their relevance.
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FDA's Digital Health Technologies Framework Addresses Important Challenges
5/16/2023
In March 2023, CDER and CBER published a Framework for the Use of Digital Health Technologies (DHTs) in Drug and Biological Product Development (the “Framework”) to “guide the use of DHT-derived data in regulatory decision making for drugs and biological products.” Here is what you need to know.
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Speed Up, Collect More, And Reach Further: Using RWD To Optimize Your Clinical Trials
5/10/2023
The benefits of real-world data (RWD) have been so promising, the FDA now recognizes RWD — and corresponding real-world evidence (RWE) — as valid tools for monitoring the safety of products post-market and, in some cases, for making regulatory approval decisions. At Freenome, we first integrated the use of RWD during a clinical study launched in 2022 for the early detection of multiple cancers. Along the way, we’ve discovered several benefits RWD can bring to any clinical research program.
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New Advancement Toward The First Primary Endpoint Qualification Of A Digital Endpoint For Duchenne
4/27/2023
Current methods for assessing ambulatory function in patients with Duchenne muscular dystrophy do not fully reflect how they experience DMD in their daily lives. Now, researchers have developed a new endpoint measured by a wearable device that records a patient's fastest spontaneous strides outside the clinic. What's more, it could become the first-ever digital primary endpoint approved by regulators.
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Why Developing A Metrics-Driven Culture Is A Clinical Operations Must-Do
4/14/2023
The number of systems used to support the conduct of clinical trials has increased and the amount of data used to monitor our portfolio, studies, and processes has soared. While there is still value in using traditional dashboards and reports, the use of advanced analytics and RWD/E is enabling us to ask more sophisticated questions to be more predictive — what will happen — and prescriptive — how to make it happen.
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AI And Healthcare Disparities: Driving A Wedge Or Closing The Gap?
3/31/2023
The enthusiasm for the role of AI in upgrading global health and care provision is justified, provided we understand that the path to success is just as much about communication and collaborative development as it is about the raw potential of the technology itself. Because realizing this technological potential requires us to consider the role of people and processes in an integrated approach.
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The CDISC Open Rules Engine (CORE): Open-Source Software For Clinical Trials
3/29/2023
Open-source software development, widely used across most industries globally, has recently been gaining ground in clinical research. Discover how CDISC's Open Rule Engine (CORE) can make sharing standardized data sets easier and improve your workflow.
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Unlocking The Potential Of RWD: Validating Prevalence Estimates For Rare Diseases
3/27/2023
Real-world data (RWD) has proven to be valuable in studying rare diseases. Incorporating RWD has led to the identification of previously undetected cases and the monitoring of treatment outcomes. However, challenges such as the lack of standardized data collection and analysis methods still exist. To replicate successes, researchers should collaborate to establish standardized protocols, thereby advancing our understanding of rare diseases and improve patient outcomes.
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Consistent And Clear Terminology, Best Practices Needed To Scale Sensor-Based DHTs
3/24/2023
Sensor-based digital health technologies (DHTs) have been increasingly adopted in clinical research, clinical care, and everyday life, but a lack of clarity regarding usability best practices means that not all of these tools can be successfully implemented at scale.