Rethinking Clinical Trials

JANUARY 23, 2024

Similar to most types of trials, there are pros and cons to both pragmatic and explanatory designs in imaging trials. RCT design will vary depending on which CAD manifestation(s) are reflected in the information provided by the imaging test being studied, which affects the treatment target(s) being evaluated in a therapeutic trial.

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Pharmaceutical Technology

SEPTEMBER 26, 2022

Clinical trials were thrown into turmoil on the morning of 24 February 2022, along with every aspect of life in Ukraine. In July, approximately a third of companies had paused a trial in the country. By August, 28 foreign-sponsored, multi-country trials were affected, almost half with sites in Ukraine and Russia. [1].

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Medical Xpress

NOVEMBER 7, 2022

Levels of triglycerides are routinely measured as part of a preventive cardiology work-up and lowering triglycerides with several classes of drugs is common medical practice.

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Rethinking Clinical Trials

SEPTEMBER 22, 2022

Professor in Translational Cardiology and Pragmatic Randomized Trials. Head of Center for Translational Cardiology and Pragmatic Randomized Trials. Head of Cardiovascular Non-Invasive Imaging Research Laboratory. Department of Cardiology. DANFLU-1, Pragmatic Clinical Trials. University of Copenhagen.

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Clinical Trial Podcast

JULY 31, 2024

To learn more about this important field of cardiovascular clinical research, I invited Dr. Gregg Stone on the podcast. Stone has been recognized in Nature Medicine as one of the most prolific authors in science, and by the Web of Science as among the top 0.01% of cited researchers in science.

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STAT News

JANUARY 6, 2023

… Pfizer told employees it plans to pull back on early-stage research into treatments for rare diseases, including the development of new viral-based gene therapies , Barron’s reports. Among the assets on the chopping block is a gene therapy manufacturing facility in Durham, N.C.,

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XTalks

DECEMBER 26, 2024

Menarini Group has announced positive topline data from the Phase III BROADWAY and TANDEM clinical trials, evaluating obicetrapib and the fixed-dose combination of obicetrapib with ezetimibe. Meanwhile, the TANDEM trial evaluated a fixed-dose combination of obicetrapib with 10 mg ezetimibe in a similar patient population.

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FDA Law Blog

NOVEMBER 10, 2024

Each year, FDA selects a limited number of clinical trials to fund to help sponsors pursue development of medical products for rare diseases and advance their field. In October, FDA announced seven new clinical trial grants awarded in fiscal year (FY) 2024 – including one for a Phase 3 trial – totaling $17.2

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Medical Xpress

MAY 10, 2023

A small randomized trial in patients with post-COVID syndrome has found that hyperbaric oxygen therapy promotes restoration of the heart's ability to contract properly. The research is presented at EACVI 2023, a scientific congress of the European Society of Cardiology (ESC).

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Scienmag

AUGUST 16, 2020

The […].

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Rethinking Clinical Trials

OCTOBER 24, 2023

REMAP-CAP is an adaptive platform trial simultaneously evaluation multiple treatments in domains using a master protocol. In adaptive trials, trial design features are modified during the trial to maximize statistical efficiency or achieve better patient outcomes. The approach definitely generated evidence more quickly.

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XTalks

OCTOBER 31, 2024

This includes new Phase III trial data for Kerendia (finerenone) in patients with heart failure that was presented recently at this year’s European Society of Cardiology (ESC) Congress 2024. Tune into the episode to hear more about the latest trial data for finerenone in heart failure and the landscape of heart failure research.

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Medical Xpress

MARCH 8, 2023

In the largest randomized trial conducted to compare minimally invasive and conventional cardiac surgical techniques for repairing a poorly functioning mitral valve, improvements in physical activity, as well as surgical outcomes and quality of life, were similar in both groups of patients at 12 weeks post-surgery.

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pharmaphorum

APRIL 25, 2022

An analysis of 10 clinical trials of digital health interventions targeted at patients recently hospitalised for acute heart failure has found they improve outcomes compared to standard care. Patients in the digital arms also lost fewer days due to hospitalisation for heart failure – 1.77 days compared to 3.06

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XTalks

NOVEMBER 19, 2021

Cardiac biomarkers can not only serve important roles in the diagnosis, management and prognosis of cardiac diseases, but they can also be significant tools in evaluating treatments in cardiovascular (CV) clinical trials. In CV clinical trials, cardiac biomarkers are most commonly included in efficacy and safety endpoints.

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Rethinking Clinical Trials

JUNE 7, 2023

The trial was designed to randomize 1,000 patients who had an On-X aortic valve replacement at least 3 months prior to randomization with either a standard dose of Apixaban (5mg) or continued warfarin (the standard of care). The trial took place at 64 sites, and randomized 863 patients. Learn more Read about the PROACT Xa study.

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XTalks

FEBRUARY 6, 2024

Srivastava highlights the disheartening facts related to mortality including that a CKD patient is more likely to die from CVD before ever having progressed to requiring dialysis, a life-saving therapy for those with end-stage kidney disease (ESKD), emphasizing the urgent need for increased research in this area. 18: 2918-2926.

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Trialfacts

DECEMBER 5, 2022

Researchers working with Novo Nordisk are conducting a research study with an investigational new medication, for people with inflammation, heart and chronic kidney disease. Are you interested in potentially joining this research study? Participants will be helping to advance medical research. Research Site 1: St.

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Velocity Clinical Research

DECEMBER 6, 2023

Velocity Clinical Research, the leading multi-specialty clinical sites business, announced it has expanded into Poland, acquiring its first site, ClinMedica Research. The site is recognized as one of the best research facilities in the country by Sponsors and contract research organizations (CROs).

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pharmaphorum

OCTOBER 2, 2020

The five new NIHR National Patient Recruitment Centres (NPRCs) are set to shape the future of commercial clinical trials in the UK by offering new ways to conduct late-phase, large-scale research projects. The webinar will also cover: What the NPRCs’ franchise model means for research delivery.

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Rethinking Clinical Trials

FEBRUARY 14, 2024

DCP learned that leveraging health systems for large-scale clinical trials is feasible. How long did the start up for the trial take? Other key success factors were the creative thinking across the study team and the excellent study coordination and partnership within the health system. The actual startup was about 18 months.

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ACRP blog

JANUARY 24, 2023

This expanded clinical research opportunities for patients as a core pillar of the affiliation’s mission, with the goal of providing access to novel treatments for diagnoses in addition to standard of care. An important step was a review of the state of clinical trial awareness at the time of the affiliation agreement.

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XTalks

APRIL 7, 2022

XTALKS WEBINAR: Cardiac Safety Solutions in Decentralized Clinical Trials (DCT). Register for this webinar to learn why cardiac safety testing is critical for clinical trial participants. Webinar attendees will also learn how BioTel Research is making waves in cardiac safety testing.

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XTalks

AUGUST 4, 2022

Cardiovascular clinical trials need to have a diversity plan because there can be a difference in disease burden when comparing people of different race and ethnicity. The US Food and Drug Administration (FDA) is emphasizing the need for diversity in clinical trials. In the same webinar, Dr. Hansie M.

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XTalks

SEPTEMBER 4, 2024

Alnylam Pharmaceuticals announced promising results from its HELIOS-B Phase III clinical trial evaluating vutrisiran, an investigational RNA interference (RNAi) therapeutic for treating transthyretin amyloidosis with cardiomyopathy (ATTR-CM). While HELIOS-A focused on nerve damage, HELIOS-B expands vutrisiran’s use to cardiomyopathy.

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Trialfacts

APRIL 2, 2024

Your unique experiences hold the potential to illuminate the path of medical research. Your involvement is crucial in helping researchers understand how a potential treatment compares to a placebo for individuals dealing with obesity and heart-related issues. Participants will be helping to advance medical research.

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Velocity Clinical Research

NOVEMBER 21, 2023

“Without clinical research, there would be little if any development of new medicines,” says Isabelle Schenkenberger, MD. I’m proud and excited to be a part of it.” Dr. Schenkenberger is especially proud of her clinical trial research work in heart health, noting most new drugs never make it to market.

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Velocity Clinical Research

MARCH 19, 2024

Velocity recently convened more than 40 leaders from around the world for a summit on Councils to Accelerate Research Excellence (CARE). The summit focused on Velocity’s Diabetes + Obesity, MASH, Vaccine, Cardiology, and Women’s Health CARE Councils, along with a few areas in development.

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pharmaphorum

FEBRUARY 25, 2022

. “While Jardiance may not be effective in all patients with heart failure, this approval is a significant step forward for patients and our understanding of heart failure,” says Norman Stockbridge, MD, PhD, director of the Division of Cardiology and Nephrology in the FDA’s Center for Drug Evaluation and Research.

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The Pharma Data

AUGUST 22, 2021

Alexion is discontinuing CHAMPION-ALS, the global Phase III clinical trial of Ultomiris (ravulizumab) in adults with amyotrophic lateral sclerosis (ALS). The IDMC recommended that the trial be discontinued due to lack of efficacy. Data from the trial will be provided to inform ongoing research. CHAMPION-ALS.

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Medical Xpress

NOVEMBER 7, 2022

Performing open bypass surgery to restore circulation for people with a severe form of peripheral artery disease (PAD)—a condition that limits blood flow to the legs and feet—resulted in better outcomes for specific patients compared to a less-invasive procedure, a National Institutes of Health-supported clinical research trial has found.

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Scienmag

MARCH 16, 2021

Also approves new funding for three high-burden topics (Washington) — Patients, clinicians and families facing uncertainty about their choices for managing Type 2 diabetes and rare diseases will gain new evidence to inform their decision making from comparative clinical effectiveness research (CER) studies that the Patient-Centered Outcomes Research (..)

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The Pharma Data

JANUARY 20, 2021

Trial designed to investigate the cardioprotective properties of CardiolRx(TM) in patients hospitalized with COVID-19 who have a prior history of, or risk factors for, cardiovascular disease. The DSMC comprises independent experts who will assess the patient safety data, and, if needed, critical efficacy endpoints of the trial.

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Scienmag

JUNE 17, 2021

Tools for clinicians in point-of-care use UTICA, NY — More than 2 million coronary artery stents are implanted each year to help protect or restore normal blood flow to the heart, to treat patients suffering from angina or a heart attack due to coronary artery disease (CAD). While stents are highly effective and safe devices, […].

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The Pharma Data

AUGUST 30, 2021

Results from the Phase III EMPEROR-Preserved trial were presented today at the European Society of Cardiology Congress 2021 2 and published in The New England Journal of Medicine 1. 1 Trial participants were randomly assigned to empagliflozin 10 mg (n=2,997) or placebo (n=2,991) once daily.

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pharmaphorum

JUNE 25, 2021

But Dr Craig Granowitz, chief scientific officer of cardiology drug developer Amarin, says that this is only the tip of the iceberg when it comes to the devastating impact of CVD on global populations. “In Meanwhile, the pandemic has taught the scientific community much about human biology, which can be applied to CVD research going forward.

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Scienmag

FEBRUARY 7, 2021

Beer-Sheva, Israel…February 8, 2021 – A new discovery by researchers from Ben-Gurion University of the Negev (BGU) and its affiliated Soroka University Medical Center shows that medical cannabis may reduce blood pressure in older adults.

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