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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
A young man treated with Elevidys died of acute liver failure. The case may give doctors pause before prescribing the treatment in the future, some analysts wrote.
Researchers report a discovery in cardiac regeneration that offers new hope for the treatment of ischemic heart failure. Published in npj Regenerative Medicine, the study reveals a novel approach to promoting cardiomyocyte proliferation. The researchers are from the Michael E. DeBakey Department of Surgery at Baylor College of Medicine, the QIMR Berghofer Medical Research Institute in Brisbane, Australia, and collaborating institutions.
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
A Parliamentary Panel has recommended implementation of a comprehensive, nationwide and phased Medicines Regulatory Maturity Enhancement Programme on the lines of World Health Organisation’s (WHO) vaccine benchmarking process to ensure a consistently high standard of drug regulation across the country.
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.
In a cost-effectiveness analysis using data from the ABATE Infection trial, a strategy of chlorhexidine bathing and nasal decolonization targeted to hospitalized adults with medical devices in nonintensive care unit (ICU) settings was cost-effective in reducing hospital-acquired infections. The study results were published this month in JAMA Network Open.
In a cost-effectiveness analysis using data from the ABATE Infection trial, a strategy of chlorhexidine bathing and nasal decolonization targeted to hospitalized adults with medical devices in nonintensive care unit (ICU) settings was cost-effective in reducing hospital-acquired infections. The study results were published this month in JAMA Network Open.
A new publication from the FDA Oncology Center of Excellence (OCE) and the Clinical Trials Transformation Initiative (CTTI), published in the Clinical Cancer Research journal, provides important insights into how decentralized clinical trial (DCT) elements were used in cancer trials leading to FDA approval during the COVID-19 pandemic. DCT elementssuch as remote monitoring, telemedicine, and home delivery of investigational products were widely used in cancer trials to maintain patient safety an
Do ice baths live up to the hype? (Diana Light/Unsplash) Ice baths have become increasingly popular over the past few years. Fitness enthusiasts and casual exercisers around the world are embracing this trend that was once reserved for elite athletes. Ice baths (also known as “cold water immersion“) are exactly what they sound like.
Philips has initiated a recall and discontinued the distribution of its Tack endovascular system after reports surfaced that users experienced challenges during procedures. The FDA classified this recall as the most serious type of recall (Class I), urging healthcare facilities to immediately halt use of the product. Designed to treat blood vessel dissection a condition that can occur when arteries are widened during angioplasty (a procedure that uses a balloon or stent to open narrowed arterie
Researchers with PRIM-ER, an NIH Collaboratory Trial, published 2 innovative statistical techniques for evaluating intervention effects in stepped-wedge, cluster randomized trials. The new models, which use Bayesian methods, outperformed traditional analytic methods and other Bayesian approaches in simulations and real-world applications. The article was published online in Statistics in Medicine.
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.
Studies reveal that people with Down syndrome (DS) have over a 90% lifetime risk of developing dementia caused by Alzheimer's disease (AD) as they age. Research from the University of Pittsburgh's Swanson School of Engineering aims could uncover why some people with DS develop dementia while others do not providing insight that could ultimately benefit the entire DS community.
(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?
A 16-year-old patient died after treatment with Elevidys (delandistrogene moxeparvovec), Sarepta Therapeutics gene therapy for Duchenne muscular dystrophy (DMD). The patient suffered acute liver failure several months after receiving the therapy in December. Liver injury is a known risk with Elevidys and other gene therapies that use adeno-associated viral (AAV) vectors.
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
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.
Amvuttra’s clearance in a rare form of cardiomyopathy could help Alnylam turn a regular profit — if it can wrest control of a competitive and fast-changing market.
A team of researchers at the University Medical Center Schleswig-Holstein (UKSH), Kiel Campus, the Kiel University, and the Max Planck Institute for Molecular Genetics, Berlin, have developed an innovative method for real-time molecular genetic classification of brain tumors during surgery. This approach combines DNA methylation analysis with advanced machine learning technologies to provide detailed information about the tumor type during surgery.
After a long, stressful day at work, or when pressed for time, the temptation to have a quick, satisfying snack like crisps or a chocolate bar can be strong.
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.
Consumers of popular culture in the 1960s and 1970s preferred their artificial intelligence (AI) to come with overtones of danger, if not outright world domination, judging by small- and large-screen science fiction artifacts ranging from episodes of the original Star Trek series to movies like 2001: A Space Odyssey and Colossus: The Forbin Project.
Dr. Sara Singer, principal investigator for iPATH Researchers from iPATH, an NIH Collaboratory Trial, described key considerations for integrating artificial intelligence tools into analyses of qualitative data. The report was posted this month on the AcademyHealth Blog. The iPATH trial, led by principal investigator Sara Singer at Stanford University, will test the implementation of a practice transformation strategy for type 2 diabetes in federally qualified health centers in California, Massa
A panel of CDC advisers, who had been set to meet in February, will discuss the current measles outbreak as well as guidelines for several types of shots.
On March 7, 2025, Advanced Biomed Inc. raised $6.56 million in its IPO and began trading on Nasdaq under the ticker ADVB. The biotech firm, which develops semiconductor-based microfluidic technology for early cancer detection, issued 1.64 million shares at $4 each, with an option to purchase an additional 246,000 shares within 45 days. Current Share Price: Established in 2014, Advanced Biomed has developed a proprietary microfluidic platform that functions as a compact laboratory on a chip.
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.
The Indian Council of Medical Research (ICMR) is working to set up a Centre for Advanced Research in Aging, marking a significant move in India’s efforts to address the challenges of aging and age-related diseases.
Craig Koch has been appointed as Velocitys new Executive Vice President, Europe, to spearhead the next phase of growth across the region. His appointment underscores the companys long-term commitment to Europe. Previously serving as EVP, Global Head of Sales, Craig has been with Velocity since 2019. He is now relocating to Europe to provide hands-on leadership as Velocity scales its integrated site network model across the continent.
Speaker Sean Mann Senior Policy Analyst RAND Corporation Slides Keywords Development Economics; Spillover; Bias; Pragmatic Clinical Trials Key Points Individually randomized, parallel-group embedded pragmatic trials randomly assign patients to a new healthcare intervention or to a control group that receives some form of usual care.
Are you currently in sales, or involved in a business that depends on strong sales results? What about the extremely competitive world of medical device sales? What are some of the top challenges your customers face and how do you approach understanding what’s most important to them? Join Steve Goldstein, Sales Success Coach, Motivational Speaker and Medical Device Sales Leader from Gold Selling LLC., to discover critical strategies and approaches you can take to engage your customers, achieve g
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