Rethinking Clinical Trials

SEPTEMBER 14, 2022

Tor Biering-Sørensen of the University of Copenhagen will present “Using Nationwide Registries to Conduct Pragmatic Randomized Trials: The DANFLU Program.” The post September 14, 2022: PCT Grands Rounds Will Explore Feasibility of National Registry-Based Pragmatic Trials appeared first on Rethinking Clinical Trials.

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Rethinking Clinical Trials

JULY 24, 2024

Fonarow is the Eliot Corday Professor of Cardiovascular Medicine and Science at UCLA, director of the Ahmanson-UCLA Cardiomyopathy Center, and codirector of the UCLA Preventative Cardiology Program. Join the online meeting.

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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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Rethinking Clinical Trials

JULY 12, 2023

Neha Pagidipati In this Friday’s PCT Grand Rounds, Christopher Granger and Neha Pagidipati of Duke University will present “Lessons From the COORDINATE-Diabetes Trial.” The post July 12, 2023: In This Week’s PCT Grand Rounds, Lessons From the COORDINATE-Diabetes Trial appeared first on Rethinking Clinical Trials.

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Rethinking Clinical Trials

NOVEMBER 9, 2022

Interventional/Structural Fellow, Cleveland Clinic. Clinical Trial, Medical Education. The goal of the CardioNerds Clinical Trials Network is to pair equitable enrollment with trainee development. Like many trials during the COVID-19 pandemic, there were significant challenges and recruitment delays.

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Rethinking Clinical Trials

NOVEMBER 2, 2022

Amit Goyal of the Cleveland Clinic will present “The CardioNerds Clinical Trials Network: Pairing Equitable Enrollment With Trainee Development.” Goyal is a fellow in interventional/structural cardiology at the Cleveland Clinic and a cofounder of CardioNerds, an initiative to democratize cardiovascular education.

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Rethinking Clinical Trials

NOVEMBER 22, 2022

A concordance analysis from ADAPTABLE, a large pragmatic, comparative effectiveness trial, found low to moderate agreement between patient-reported health data and data derived from the electronic health record (EHR). Results of the study were published in JAMA Cardiology. Read the full report in JAMA Cardiology.

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Clinical Trial Podcast

JULY 31, 2024

Stone is an Interventional Cardiologist and Director of Academic Affairs for the Mount Sinai Heart Health System and Professor of Medicine (Cardiology) and Professor of Population Health Sciences and Policy at the Icahn School of Medicine at Mount Sinai in New York, NY. Sponsor(s): This podcast is brought to you by Florence Healthcare.

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CTTI (Clinical Trials Transformation Initiative)

DECEMBER 21, 2022

It’s Time to Revamp How Clinical Trials Are Done, Say Cardiology Societies. The post It’s Time to Revamp How Clinical Trials Are Done, Say Cardiology Societies appeared first on CTTI.

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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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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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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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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

FEBRUARY 12, 2025

In key registration-enabling, placebo-controlled trials, patients received once-monthly doses of lerodalcibep for up to 52 weeks. Results from the trials demonstrated that lerodalcibep achieved significant reductions in LDL-C levels. Over 2,400 patients have continued in the 72-week open-label extension trial.

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Rethinking Clinical Trials

JULY 19, 2023

However, these therapies are highly underused in routine clinical practice. The objective of COORDINATE-Diabetes trial was to improve the implementation and adoption of these therapies by testing the impact of a clinic-level, multifaceted intervention on the prescription of 3 key groups of evidence-based therapies.

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STAT News

JANUARY 6, 2023

The company said it would “externalize” most of its early-stage rare disease programs in neurology and cardiology, and gene therapy programs not yet in clinical trials. Among the assets on the chopping block is a gene therapy manufacturing facility in Durham, N.C.,

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Medical Xpress

APRIL 21, 2023

More than 70 people presenting at Singapore General Hospital's emergency room with chest pain have been recruited to a new randomized controlled trial of a novel AI-based cardiac risk stratification tool that can rapidly and in real-time identify people whose chest pain is a sign of more serious trouble.

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Scienmag

AUGUST 16, 2020

Analysis lead by Penn Medicine identified gender disparities in authorship of heart failure guideline citations and clinical trials PHILADELPHIA– While about a quarter of physicians and researchers working in advanced heart failure (HF) and transplant cardiology are women, representation of women leading HF research remains limited, according (..)

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Scienmag

OCTOBER 15, 2020

Randomized trial studies device designed to reduce embolic events in patients undergoing TAVR NEW YORK – October 15, 2020 – The REFLECT II randomized clinical trial evaluating the safety and efficacy of a device designed to reduce cerebral embolization and ischemic stroke, complications of transcatheter aortic valve replacement (TAVR), (..)

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Medical Xpress

FEBRUARY 21, 2023

Minority ethnicities and regions derive at least as much cardiovascular benefit from lipid-lowering therapies as majority groups despite being underrepresented in clinical trials, according to a study published today in the European Journal of Preventive Cardiology.

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Scienmag

DECEMBER 3, 2020

In a randomized, controlled clinical trial, researchers found that patients who received genetic test results about the side effects of cholesterol-lowering medications did not have worse outcomes after one year A person’s genetic make-up can influence whether they might experience side effects from certain medications.

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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. The featured speakers will discuss why at-home data collection and analyses must be comparable to in-clinic testing.

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BioTech 365

OCTOBER 2, 2020

–(BUSINESS WIRE)–The Journal of the American College of Cardiology published results of the Phase III GadaCAD 1 and GadaCAD 2 clinical trials for … Continue reading → Coronary artery disease (CAD) is a critical public health issue, affecting an estimated 16.5 million Americans1 WHIPPANY, N.J.–(BUSINESS

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Rethinking Clinical Trials

APRIL 13, 2023

The PRESCRIBE trial revealed the value of active choice as well as peer decision-making to prompt decision-making. Discussion Themes – In the last few years, there has been great reception to the value of behavioral science and implementation science in the field of cardiology.

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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. How the centres will provide quicker and easier clinical studies.

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Scienmag

OCTOBER 19, 2020

Randomized clinical trial finds no mortality risk or benefit associated with drug-coated devices in the treatment of peripheral artery disease NEW YORK – October 18, 2020 – A large subgroup analysis of a randomized clinical trial showed neither a mortality risk nor benefit associated with the use of paclitaxel drug-coated devices (DCD) (..)

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XTalks

JULY 7, 2023

a Canadian biopharmaceutical firm specializing in cardiovascular therapies, recently reported positive results from a Phase III clinical trial of its leading candidate, etripamil nasal spray, for the treatment of paroxysmal supraventricular tachycardia (PSVT). Milestone Pharmaceuticals Inc.,

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Trialfacts

DECEMBER 5, 2022

It is involved in and leading in many clinical trials for Type 1 and Type 2 Trials both investigator initiated and sponsor lead trials. Consisting of Nephrology and Cardiology, we are dedicated and hardworking teams. Specialising in all phases of clinical trials regarding heart and kidney disease.

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Scienmag

AUGUST 31, 2020

EXPLORER-HCM trial presented in a Hot Line Session today at ESC Congress 2020 Sophia Antipolis, France – 29 Aug 2020: Mavacamten improves heart function and symptoms in patients with obstructive hypertrophic cardiomyopathy, according to results of the EXPLORER-HCM trial presented in a Hot Line session today at ESC Congress 2020.1 “The results (..)

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Medical Xpress

FEBRUARY 6, 2023

Clinical trials have started for the first prosthetic pulmonary valve replacement that is specifically designed for pediatric patients and can expand over time inside a child's anatomy.

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pharmaphorum

OCTOBER 8, 2020

UK-based RHYTHM AI is to go ahead with a larger clinical trial of its artificial intelligence (AI)-driven system, which could be used as a treatment for atrial fibrillation without the need for medication. The post RHYTHM AI cleared for large trial of atrial fibrillation mapping tool appeared first on. months follow up.

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Scienmag

NOVEMBER 16, 2020

SCORED trial of patients with diabetes and chronic kidney disease is first trial of an SGLT2 inhibitor to show benefit across the full range of albuminuria; SOLOIST shows an SGLT2 inhibitor is safe to start in patients hospitalized with heart failure Boston, MA — Less than a decade ago, the Food and Drug Administration approved […].

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Velocity Clinical Research

NOVEMBER 21, 2023

Schenkenberger is especially proud of her clinical trial research work in heart health, noting most new drugs never make it to market. She’s been involved in several trials that have made a difference for patients, including Entresto, a drug that’s been “a big step forward for heart failure patients,” she says.

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pharmaphorum

JUNE 17, 2022

The UK-based but US-listed biotech licensed rights to AZ’s orally-active neutrophil elastase inhibitor alvelestat for the rare disease alpha-1 antitrypsin deficiency (AATD) five years ago, and has since advanced the project into a phase 2 trial which is due to read out in the second half of this year.

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Scienmag

NOVEMBER 13, 2020

Their clinical trial showed that this medication can improve the heart’s size, shape, and function, leading to better exercise capacity and quality of life, […].

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Velocity Clinical Research

DECEMBER 6, 2023

In addition to being one of Poland’s top recruiting sites in cardiology trials, ClinMedica also recruits patients across a broad range of therapeutic areas involving ambulatory medicine. As a result, Sponsors and CROs can benefit from simplified access to international clinical research capabilities. and Europe.

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Scienmag

MARCH 10, 2021

Credit: AlphaMed Press Durham, NC – Results of a clinical trial released in STEM CELLS Translational Medicine provide evidence that treating patients with an injection of bone marrow cells may lead to a reduction in brain injury after a stroke. The study was conducted by Muhammad E. Haque, Ph.D., Savitz, M.D.,

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