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

DECEMBER 20, 2023

Yet enrollment of ethnic minorities in NIH clinical trials and for trials studying approved devices and drugs remains low. There are several strategies that will help increase diversity in CVD trials. Increasing diversity in trial leadership is one of the most important strategies to increase diversity among RCT participants.

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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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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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Rethinking Clinical Trials

JULY 19, 2023

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. This was a cluster-randomized trial of 42 cardiology clinics across the U.S.,

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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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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

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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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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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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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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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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Rethinking Clinical Trials

NOVEMBER 9, 2022

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. The fellows were responsible for 45% of enrollment during the time of the trial.

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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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Drug Discovery World

NOVEMBER 25, 2022

According to the partnership between the University of Birmingham and Acticor Biotech, the trial will take place in two hospitals in the UK: the Queen Elizabeth Hospital, Birmingham and the Northern General Hospital, Sheffield.

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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

MARCH 6, 2023

In staged treatment, the blocked artery that caused the heart attack is treated with a stent immediately and other partially blocked arteries are treated in a second procedure up to six weeks later.

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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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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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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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pharmaphorum

AUGUST 30, 2022

Bayer is pressing ahead with a phase 3 trial of its oral Factor XIa inhibitor asundexian, a new anticoagulant, despite missing efficacy targets in two mid-stage studies. In the AXIOMATIC-SSP trial, milvexian was compared to placebo in patients with prior ischaemic stroke or high-risk TIA, on top of aspirin and antiplatelet therapy.

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Drug Discovery World

MARCH 15, 2023

The primary endpoint has been achieved in a Phase II trial of AP30663, a first-in-class SK ion channel inhibitor for conversion of atrial fibrillation (AF) to normal sinus rhythm. Acesion Pharma enrolled 63 patients with a current episode of AF in the trial and tested two intravenous doses of AP30663, 3 and 5mg/kg, compared to placebo.

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WCG Clinical

MAY 22, 2023

Despite the growing consensus around the need for diversity in clinical trials, the industry still has a long way to go. 4,5 In fact, lack of representation in clinical trials compromises generalizability of research findings. Increasing Diversity in Clinical Trials: Overcoming Critical Barriers. Current Problems in Cardiology.

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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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pharmaphorum

MARCH 9, 2021

The rationale came from the CANTOS trial where patients treated with canakinumab in atherosclerotic disease appeared to have a reduced risk of lung cancer mortality, in findings presented at the 2017 European Society of Cardiology congress.

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Velocity Clinical Research

MARCH 19, 2024

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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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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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. What’s Next?

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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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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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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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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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Drug Discovery World

DECEMBER 20, 2023

The company has 155 investigators who perform trials in around 20 therapeutic areas, including infectious disease, neurology, endocrinology, oncology, cardiology, dermatology and vaccines.

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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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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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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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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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