Sat.Oct 28, 2023 - Fri.Nov 03, 2023

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3 Best Practices for Patient Engagement in Clinical Trials

XTalks

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.

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Clinical Trials Could Yield Better Data with Fewer Patients Thanks to New Tool

ACRP blog

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

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Why prospective real-world studies hold so much promise for clinical research

Bio Pharma Dive

PrwS studies can reach beyond the limitations of today’s RWE studies and expand the role of RWD across the entire drug development cycle.

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Grand Rounds October 27, 2023: Digital, Decentralized and Democratized: Lessons From The Yale PaxLC Trial (Harlan M. Krumholz, MD, SM)

Rethinking Clinical Trials

       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

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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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‘Grave Consequences’: Scientists Warn of Extreme Bias in Brain Aging Research

AuroBlog - Aurous Healthcare Clinical Trials blog

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.

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Streamlining Clinical Trials: Common Workflow Automations in Electronic Trial Master File (eTMF) Systems

Cloudbyz

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.

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What Successfully Recruited Post-COVID Oncology Trials Have in Common

Worldwide Clinical Trials

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.

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Optimizing Biomarker Assays to Bridge the Clinical Trial Participation Gap

BioSpace

Optimizing Biomarker Assays to Bridge the Clinical Trial Participation Gap - read this article along with other careers information, tips and advice on BioSpace

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Vertex, CRISPR therapy for sickle cell passes FDA panel test

Bio Pharma Dive

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.

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Memo Therapeutics raises $27.67m for kidney transplant infection trial

Pharmaceutical Technology

Memo’s fast track-designated candidate is currently in a Phase II trial for BKV infection, with a data readout expected in 2024.

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The New Age of Decentralized Clinical Trials

White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

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Do You Bruise Easily? It Could Be A Sign Of Something More Serious

AuroBlog - Aurous Healthcare Clinical Trials blog

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.

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October 31, 2023: NIH Pragmatic Trials Collaboratory Welcomes 5 New Demonstration Projects

Rethinking Clinical Trials

The NIH Pragmatic Trials Collaboratory is excited to announce the addition of 5 new large-scale pragmatic clinical trials to its portfolio of innovative Demonstration Projects, which will extend the program’s mission to strengthen the national capacity to implement cost-effective, large-scale research studies that engage healthcare delivery organizations as research partners.

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Tracking the FDA’s meeting on Vertex, CRISPR’s sickle cell therapy

Bio Pharma Dive

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.

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ArriVent’s lung cancer therapy gains FDA breakthrough therapy status 

Pharmaceutical Technology

ArriVent Biopharma has received the US FDA's breakthrough therapy designation for furmonertinib to treat non-small cell lung cancer.

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How Machine Learning Drives Clinical Trial Efficiency

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.

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Simply Being Told You Were Given Ketamine Could Be Enough to Treat Depression

AuroBlog - Aurous Healthcare Clinical Trials blog

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.

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November 1, 2023: Special Biostatistics Series Continues With Complex Clustering in Pragmatic Trials

Rethinking Clinical Trials

In this Friday’s PCT Grand Rounds, Jonathan Moyer of the NIH Office of Disease Prevention will continue our special series, Advances in the Design and Analysis of Pragmatic Clinical Trials, with his presentation, “The Perils and Pitfalls of Complex Clustering in Pragmatic Trials.” The session will be held on Friday, November 3, at 1:00 pm eastern and will be moderated by Andrea Cook.

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Moderna adjusts to changing outlook for COVID vaccine demand

Bio Pharma Dive

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.

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FDA grants approval for Novartis’ hidradenitis suppurativa treatment

Pharmaceutical Technology

The US FDA has granted approval for Novartis’ Cosentyx to treat adult patients with moderate to severe hidradenitis suppurativa (HS).

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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

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.

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How Old Are Your Eyes? New ‘Clock’ Could Reveal Disease Risk

AuroBlog - Aurous Healthcare Clinical Trials blog

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.

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UPDATED: Pfizer plans to shutter New Jersey site, discloses layoffs amid $3.5B cost-cutting drive

Fierce Pharma

Editor's note: This story has been updated with a comment from Pfizer. An earlier version of the story stated that nearly 800 jobs would be affected. | After plunging COVID revenues prompted Pfizer to embark on a cost-cutting crusade, more details about the company's savings efforts are coming into focus.

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Novo, Lilly buoyed by fast-growing GLP-1 drug sales

Bio Pharma Dive

The rival companies reported strong quarterly sales growth for their latest products, which could face off as weight loss treatments next year.

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Pfizer posts reported net loss of $2.38bn for Q3 2023

Pharmaceutical Technology

Pfizer has posted a net loss of $2.38bn in Q3 2023 compared to a net income of $8.61bn during the same period of 2022.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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You Can Stop a Sneeze, But Here’s Why You Never Should

AuroBlog - Aurous Healthcare Clinical Trials blog

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.

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Pfizer cuts 200 jobs at COVID drug, vaccine plant in Michigan amid $3.5B savings campaign

Fierce Pharma

Pfizer’s plunging COVID-19 product demand has spurred a companywide cost-cutting campaign, with nearly 200 jobs now on the chopping block in Michigan. | Pfizer is cutting roughly 200 positions at its Kalamazoo site following a review of demand for its COVID-19 vaccine and antiviral Comirnaty and Paxlovid.

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Sarepta gene therapy for Duchenne misses main goal of key study

Bio Pharma Dive

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.

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Generate:Biomedicines to collaborate on oncology cell therapies

Pharmaceutical Technology

Generate:Biomedicines has entered a strategic collaboration with Roswell Park to accelerate the development of new oncology therapies

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The New Age of Decentralized Clinical Trials

This new white paper defines and details the impact of Decentralized Clinical Trials on the Pharmaceutical industry and how the impact can be measured along with steps companies can take to ensure adoption.

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DCGI adds IVD devices for diagnosis of Covid-19, RNA & DNA extraction kits in Class C risk category under MDR-2017

AuroBlog - Aurous Healthcare Clinical Trials blog

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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As COVID sales crater, Pfizer takes $5.6B in inventory write-offs on Paxlovid, Comirnaty

Fierce Pharma

For Pfizer, several years of pandemic megaprofits have soured as overstocked COVID-19 drugs and vaccines take a major toll on the drug behemoth’s financials. | Pfizer's pandemic megaprofits have soured as overstocked COVID-19 drugs and vaccines take a major toll on the drug behemoth’s financials.

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Abingworth raises $356M to invest in late-stage drug development

Bio Pharma Dive

The venture firm has supported a number of approved medicines with its co-development strategy, including Pfizer’s Besponsa and Apellis’ Empaveli.

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FDA warns of infection risks from over-the-counter eye drops 

Pharmaceutical Technology

The US FDA has issued a warning against the use of 26 over-the-counter eye drop products due to potential eye infection risks.

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Deliver Fast, Flexible Clinical Trial Insights with Spotfire

Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.