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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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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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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Pharmaceutical Technology

JUNE 21, 2023

The regulatory approval was based on the findings obtained from a double-blind, multinational, placebo-controlled, randomised clinical trial conducted in 5,522 chronic coronary disease patients.

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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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XTalks

FEBRUARY 6, 2024

Yet, despite the overwhelming evidence linking CKD with this heightened cardiovascular risk, CKD patients are often underrepresented or outright excluded from cardiovascular clinical trials. Vice President of the Medical Department and Cardiology therapeutic lead, and Heather Lohr, Sr. Director of Clinical Trial Management.

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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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Velocity Clinical Research

OCTOBER 12, 2023

Velocity is proud to unveil another groundbreaking initiative: the Cardiology Council to Accelerate Research Excellence (CARE). The proliferation of heart issues — paired with patient lifestyle factors that complicate recruitment and study design — reflect an urgent need for expert-led clinical trials.

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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. Department of Cardiology. DANFLU-1, Pragmatic Clinical Trials. The DECODE trial used registry data to identify patients with chronic kidney disease.

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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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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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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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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. The Diversity of the US Population.

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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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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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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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STAT News

AUGUST 3, 2022

Alnylam Pharmaceuticals’ treatment for an increasingly common heart disease succeeded in a closely watched clinical trial, the company said Wednesday, clearing the path to approval and affirming the promise of a drug analysts expect to reap blockbuster sales.

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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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XTalks

JANUARY 22, 2025

Since its introduction, it has become a cornerstone therapy for heart failure patients, particularly after receiving a Class 1 recommendation from the American College of Cardiology (ACC) and the American Heart Association (AHA) in 2016. The trial found that the primary composite endpoint was reduced by 40% with selexipag compared to placebo.

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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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The Pharma Data

OCTOBER 28, 2021

Bayer will present new renal and cardiovascular (CV) analyses from the comprehensive finerenone (Kerendia®) clinical trial program, including the Phase III FIGARO-DKD and FIDELIO-DKD studies, and the prespecified pooled analysis FIDELITY at the American Society of Nephrology (ASN)’s Kidney Week 2021 from 4-7 November.

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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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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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The Pharma Data

NOVEMBER 12, 2020

The DETOUR1 trial is the first-in-man trial of the FDA-designated Breakthrough Device, The Detour System, evaluating the safety and effectiveness of the novel procedure and device system for treating long, complex lesions in the superficial femoral artery (SFA). About the Company: PQ Bypass, Inc.

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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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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

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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