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Sean Mann In this Friday’s PCT Grand Rounds, Sean Mann of RAND will present “Spillover Due to Constraints on Care Delivery: A Potential Source of Bias in Pragmatic Clinical Trials.” The Grand Rounds session will be held on Friday, March 14, 2025, at 1:00 pm eastern. Mann is a senior policy analyst at RAND. Join the online meeting. The post March 12, 2025: In This Week’s PCT Grand Rounds, Spillover as a Potential Source of Bias in Pragmatic Trials appeared first on Rethink
(Laura Leyshon/Getty Images) If you head to the shops to buy bread, you’ll face a variety of different options. But it can be hard to work out the difference between all the types on sale. For instance, you might have a vague idea that wholemeal or wholegrain bread is healthy. But what’s the difference?
Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.
The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven
The benefits of diversity and inclusion in clinical research are widely recognized, yet the financial and operational costs of these efforts are often overlooked. Practical strategies are needed to identify and mitigate these hidden costs, helping organizations create effective and sustainable strategies. These will be more important than ever if current U.S.
In an article published online ahead of print , leaders from the NIH Pragmatic Trials Collaboratory share lessons learned about the importance of independent oversight by a safety office or data and safety monitoring board in pragmatic clinical trials, even for trials deemed to have minimal risk. Challenges specific to pragmatic trials include: complexity, quality, and timing of a real-world data pipeline, especially in trials with many heterogeneous sites embedding of interventions in clinical
The joint venture with generative AI firm Hologen hands MeiraGTx $200 million up front as well as other financial perks — a “transformative” deal, according to the company’s CEO.
The joint venture with generative AI firm Hologen hands MeiraGTx $200 million up front as well as other financial perks — a “transformative” deal, according to the company’s CEO.
Arvinas and Pfizer have reported positive Phase III VERITAC-2 results in a trial of 624 patients across 26 countries, demonstrating that vepdegestrant (ARV-471) monotherapy significantly improves progression-free survival in adults with estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) advanced or metastatic breast cancer.
Speaker F. Perry Wilson, MD MSCE Associate Professor of Medicine and Public Health Director, Clinical and Translational Research Accelerator Yale University New Haven, CT Slides Keywords Electronic Alerts; Acute Kidney Injury; Action Team Key Points Acute Kidney Injury (AKI), or abrupt decline in kidney function, is common, affecting about 15% of hospitalized patients.
In 2025, as market pressures intensify and companies refocus on core strategic priorities, medical device and medtech companies have been forced to make tough decisions regarding their workforces. These developments come amid a broader nationwide trend of workforce realignment, with both private and public entities, including the FDA’s recent rehires amid mass layoffs, adapting to ongoing pressures.
The Unseen Heroes of Generic Drugs: Stability Testing 101 As a consumer, have you ever stopped to think about the rigorous process that goes into bringing a generic version of your favorite medication to market? It's not just a matter of copying a formula and slapping a new label on it. Behind the scenes, generic drug manufacturers are working tirelessly to ensure that their products are safe, effective, and identical to their branded counterparts.
Luke Boylan, MBChB, MBA, Principal Investigator at Velocity in North London, recently attended the Parexel Site Alliance Network event. This collaborative gathering included NHS/NIHR-affiliated sites and other commercial research organizations, providing an invaluable opportunity to discuss the evolving landscape of clinical trials in the U.K. Dr. Boylans key takeaways from the event: Regulatory Improvements: There was strong consensus from the MHRA on the need for faster regulatory approval tim
Novo Nordisks investigational obesity combination drug, CagriSema (a fixed dose combination of cagrilintide 2.4 mg and semaglutide 2.4 mg), underperformed in its latest clinical trial, leading to a dip in the companys share price. In response to the trial outcomes, Novos shares declined by approximately 8% this week. Novo shared the latest data from the Phase III REDEFINE 2 trial evaluating the drug in overweight or obese patients with type 2 diabetes.
Clinical trial data management is increasingly challenging as studies grow in complexity. Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. In this paper, we explore real-time data access and analysis for proactive study management. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.
Monkeys infected with Ebola can be cured with a pill, according to a new study out Friday that could pave the way for more practical, affordable treatments in humans.
The Future of Generic Drugs: How Technology is Revolutionizing the Industry As we continue to navigate the ever-changing landscape of healthcare, one thing is clear: technology is playing an increasingly important role in shaping the future of generic drug development. From AI-powered discovery to 3D printing, the latest advancements are not only speeding up the process but also making it more efficient and cost-effective.
Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist
What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.
Perfuze advances stroke care with FDA 510(k) clearance for its new Zipline access catheters. Designed to support the delivery of large aspiration catheters during neurointerventional procedures, the device aims to enhance physicians ability to quickly remove blood clots from patients suffering from acute ischemic stroke a condition where every minute matters.
Navigating the Complex World of Biosimilar Supply Chains As the demand for biosimilars continues to grow, so do the challenges associated with their supply chains. From manufacturing and quality control to distribution and regulatory compliance, the stakes are high for pharmaceutical companies looking to bring these life-changing treatments to market.
The agency formulated its advice to manufacturers after coordinating with the CDC and Defense Department. An advisory meeting that's typically held was canceled last month.
A research study conducted by The Journal of Commerce and FourKites surveyed hundreds of international shippers, exploring how their usage of global supply chain visibility technology has evolved since the onset of global disruptions caused by COVID-19. For international shippers, ocean freight visibility has evolved from optional to essential and satisfaction with visibility varies greatly depending on how it is obtained and delivered.
Following the success of Issue 3 , which focused on the critical importance of patient diversity in clinical research, Xtalks is thrilled to announce Xtalks Clinical Edge Issue 4. This 4th edition will explore the exciting space of next-gen clinical research, unpacking novel technologies, strategies and trends that are gradually steering how the industry moves forward.
Only 43% of parents report they are able to find accurate and current information on avian influenza A(H5N1), commonly known as bird flu, according to the University of Michigan Health C.S. Mott Children's Hospital National Poll on Children's Health.
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