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The revolution in clinical research is here, and it’s embodied by a single, powerful word: “patients.” The inclusion of patients during clinical development is not only a moral imperative but a strategic necessity in modern medical research. Patients offer invaluable perspectives on their own needs, wishes and important concerns. Their input can guide the development of treatments that address their unique challenges, enhancing their overall care experience.
Following its discovery in 1799, the Rosetta stone, which features the same message in three different languages, became an invaluable tool for deciphering the previously untranslatable hieroglyphic style of Ancient Egyptian script because the other languages used on the stone were already known to linguists. Today, clinical researchers can take advantage of a new tool offering something akin to the Rosetta stone’s breakthrough gift—a way to take feedback from clinical trial participants that is
Lowering barriers to participation could boost the diversity of patients in clinical trials. We analyze gender, race and ethnicity data to understand the differences that mobile visits from a certified mobile research nurse can make.
Speaker: Simran Kaur, Co-founder & CEO at Tattva Health Inc.
AI is transforming clinical trials—accelerating drug discovery, optimizing patient recruitment, and improving data analysis. But its impact goes far beyond research. As AI-driven innovation reshapes the clinical trial process, it’s also influencing broader healthcare trends, from personalized medicine to patient outcomes. Join this new webinar featuring Simran Kaur for an insightful discussion on what all of this means for the future of healthcare!
Speaker Harlan M. Krumholz, MD, SM Harold H. Hines, Jr. Professor of Medicine Department of Internal Medicine Section of Cardiovascular Medicine Yale University School of Medicine Director, Yale-New Haven Hospital Center for Outcomes Research and Evaluation Slides Keywords Decentralized Trial, Digital Trial, Yale PaxLC Trial, Long COVID Key Points The PaxLC Trial is a decentralized Phase 2, 1:1 randomized double-blind superiority placebo-controlled study on non-hospitalized high sy
The risk of Alzheimer’s disease and depression differs significantly between male and female bodies, and yet the vast majority of research on the human brain does not reflect that. Instead, male anatomy is too often considered ‘the norm’ against which all other human brains are measured.
Clinical trials are vital for advancing medical research, but they involve complex processes and a multitude of documents that need careful management and oversight. The Electronic Trial Master File (eTMF) system is a cornerstone of clinical trial document management, providing a digital repository for essential trial documents. Leveraging workflow automations within eTMF systems can significantly enhance the efficiency and accuracy of clinical trial management.
Clinical trials are vital for advancing medical research, but they involve complex processes and a multitude of documents that need careful management and oversight. The Electronic Trial Master File (eTMF) system is a cornerstone of clinical trial document management, providing a digital repository for essential trial documents. Leveraging workflow automations within eTMF systems can significantly enhance the efficiency and accuracy of clinical trial management.
Sponsors, CROs, sites, and anyone else involved in running clinical trials must consider the risk of suicidality. But deep-rooted misconceptions get in the way. Each year, 703,000 people die by suicide. [1] The rate is rising, especially in the US. In fact, more people died from suicide in the US in 2022 than in any year on record, according to CDC data.
Last year, we witnessed a significant milestone in oncology clinical development, with almost 50% of all development programs focused on oncology assets. However, with a greater number of trials, sponsors and CROs face an increased risk of operational challenges, and sites continue to feel the widespread effects of the COVID-19 pandemic. To encourage further expansion and innovation in cancer studies, it’s critical to consider what contributes to success in an oncology trial.
Optimizing Biomarker Assays to Bridge the Clinical Trial Participation Gap - read this article along with other careers information, tips and advice on BioSpace
The high-profile meeting focused on the theoretical risks of CRISPR gene editing, as both the FDA and its advisory committee appeared convinced by the efficacy of the companies’ exa-cel treatment.
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
After a bump, we can expect a bruise. But what if we find ourselves bruising without any noticeable cause? What might be behind it? Should we worry? Around 18 percent of adults report easy bruising. As hematologists (blood doctors), we are often asked for advice when people are worried they might bruise too easily.
Expert advisers are reviewing the companies’ case for approval of what could be the first medicine based on the gene editing technology. Follow their discussion here.
For those with stubbornly resistant forms of severe depression, ketamine was looking more and more like a solution. Years of research has hinted at the dissociative anesthetic’s treatment potential where other medications failed, promising the benefits of electroshock therapy with far fewer risks.
The company recorded a net loss in the third quarter as it “resizes” its manufacturing footprint, and now expects revenue to come in at low end of its previous guidance.
Scientists have developed a new tool for determining the age of eye cells without sampling regenerative tissue, which could make treatments for eye disease more personalized and better targeted. The team, led by researchers from Stanford University, adapted a technique used for analyzing eye fluid.
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.
If you have hay fever, you’ve probably been sneezing a lot lately. Sneezing is universal but also quite unique to each of us. It is a protective reflex action outside our conscious control, to remove irritants from inside our nose.
Yet Sarepta said it still plans to ask the FDA to expand regulatory clearance of Elevidys, which was granted an accelerated approval by the FDA in June.
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.
The Drug Controller General of India (DCGI) has added in-vitro diagnostic (IVD) medical devices including those for diagnosis of Covid-19, ribonucleic acid (RNA) and deoxyribonucleic acid (DNA) extraction kits, among others into the Class C risk category under the Medical Devices Rules (MDR), 2017.
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