Cardiology, Clinical Trials, Research and Trials

Grand Rounds December 15, 2023: Diversifying Clinical Trials: A Path Forward (Roxana Mehran, MD, FACC, FAHA, MSCAI, FESC)

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. CVD is the leading cause of mortality in women. Many high school and college students are moving away from the sciences.

Clinical Trials

Clinical Trials Clinical Trials Trials Cardiology

Velocity Launches Cardiology Council to Accelerate Research Excellence (CARE)

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.

Cardiology

Cardiology Research Clinical Trials Clinical Trials

January 17, 2024: In This Friday’s PCT Grand Rounds, Why Are Imaging Trials Different?

Rethinking Clinical Trials

JANUARY 17, 2024

Lessons From Chest Pain Evaluation Trials." Douglas is the Ursula Geller Professor of Research in Cardiovascular Diseases at Duke University and a past president of both the American College of Cardiology and the American Society of Echocardiography. appeared first on Rethinking Clinical Trials.

Trials

Trials Cardiology Clinical Trials Clinical Trials

How the Ukrainian clinical trial industry is overcoming disruption

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].

Clinical Trials

Clinical Trials Clinical Trials Trials Regulation

September 14, 2022: PCT Grands Rounds Will Explore Feasibility of National Registry-Based Pragmatic Trials

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.

Trials

Trials Cardiology Clinical Trials Clinical Trials

Heart and Kidney Health for All: Expanding Cardiovascular Clinical Trials to Include CKD Patients

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.

Clinical Trials

Clinical Trials Clinical Trials Trials Clinical Research

Grand Rounds November 4, 2022: The CardioNerds Clinical Trials Network: Pairing Equitable Enrollment with Trainee Development (Amit Goyal, MD, MAS)

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.

Clinical Trials

Clinical Trials Clinical Trials Trials Development

The Scientific Rationale for Diversity in Clinical Trials

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. As one respondent said: “Appropriate representation of ethnic groups and sex are critical to the scientific validity of research findings, and their absence can lead to false conclusions.

Clinical Trials

Clinical Trials Clinical Trials Trials Cardiology

Grand Rounds January 19, 2024: Why Are Imaging RCTs Different? Lessons From Chest Pain Evaluation Trials (Pamela S. Douglas, MD, MACC, FASE, FAHA)

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.

Trials

Trials Cardiology Clinical Trials Clinical Trials

November 22, 2022: ADAPTABLE Points to Need for Better Integration of Patient-Reported Health Data Into Pragmatic Trials

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). The findings highlight the need for better integration of patient-reported health data into pragmatic research studies.

Trials

Trials Cardiology Clinical Trials Clinical Trials

Grand Rounds June 2, 2023: PROACT Xa and The Wizard of Oz: Behind the Curtain of a Pragmatic Decentralized Clinical Trial (John Alexander, MD, MHS)

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.

Clinical Trials

Clinical Trials Clinical Trials Trials Cardiology

Cardiovascular Clinical Trials with Patient Diversity: Challenges and Considerations

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.

Clinical Trials

Clinical Trials Clinical Trials Trials Clinical Research

Cardiac Biomarkers in Cardiovascular Clinical Trials: Caveats and Considerations

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.

Clinical Trials

Clinical Trials Clinical Trials Trials In-Vitro

Grand Rounds August 11, 2023: The REMAP-CAP Adaptive Platform Trial: Recent Insights and Future Directions (Patrick Lawler, MD, MPH)

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.

Trials

Trials Clinical Trials Clinical Trials Cardiology

Grand Rounds September 16, 2022: Using Nationwide Registries to Conduct Pragmatic Randomized Trials: The DANFLU Program (Tor Biering-Sørensen, MD, PhD, MPH)

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. Key Points.

Trials

Trials Cardiology Vaccination Vaccine

Velocity Clinical Research Expands to Poland

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).

Clinical Research

Clinical Research Research Clinical Trials Clinical Trials

Heart failure drug to progress to Phase II trials

Drug Discovery World

MAY 17, 2024

These data reinforce the potential of CK-586 as a drug candidate designed to directly impact the underlying hypercontractility in a subset of patients with HFpEF,” said Fady Malik, Cytokinetics’ Executive Vice President, Research and Development.

Trials

Trials Drugs Cardiology Clinical Trials

Clinical research business continues to expand in US

Drug Discovery World

DECEMBER 20, 2023

Centricity Research has acquired North Carolina-based Lucas Research, making it the fifth clinical research company to join Centricity since it launched in November 2021. With this acquisition, Centricity now has more than 35 clinical research sites, reaching 8.5

Clinical Research

Clinical Research Research Cardiology Dermatology

STAT+: Pharmalittle: Pfizer scaling back early-stage research into rare diseases; BioNTech and U.K. partner on cancer trials

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.,

Gene Therapy

Gene Therapy Trials Research Cardiology

Australian Research Study Looking at a Potential New Medication for Inflammation, in People with Heart Disease and Chronic Kidney Disease

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.

Cardiology

Cardiology Research Clinical Trials Clinical Trials

Velocity Hosts Global CARE Council Summit

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.

Cardiology

Cardiology Clinical Trials Clinical Trials Clinical Development

Clinical trial results address concerns about pharmacogenetic testing

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.

Clinical Trials

Clinical Trials Clinical Trials Trials Genetics

Shifting the Narrative on Clinical Research at a Nevada Health System

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.

Clinical Research

Clinical Research Research Clinical Trials Clinical Trials

“Nothing scares us” – Ukraine’s clinical research sector begins fearless recovery

Drug Discovery World

OCTOBER 19, 2022

Following the news that the number of clinical trial recruiting sites in Ukraine has dropped by half since the Russian invasion, DDW’s Diana Spencer examines clinical trial data from analytics company Phesi and speaks to Dr Olena Karpenko , Clinical Research Director at Medical Center Ok!Clinic+

Clinical Research

Clinical Research Research Clinical Trials Clinical Trials

Doctor Finds ‘Energizing’ Second Career as PI

Velocity Clinical Research

MARCH 7, 2024

It’s easy to hear the enthusiasm for clinical trials when William Cromwell, MD, FAHA, FNLA , Principal Investigator and a leader of the Velocity Cardiometabolic CARE Council , discusses their importance to patients yesterday, today, and tomorrow. Clinical research remains a key component of healthcare, he stresses. “A

Doctors

Doctors Doctor Clinical Research Clinical Trials

Bayer to present new data from comprehensive finerenone clinical trial program

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.

Clinical Trials

Clinical Trials Clinical Trials Trials Branding

Grand Rounds February 9, 2024: Pragmatic Recruitment of Underrepresented Groups – Experience From the Diuretic Comparison Project (Cynthia Hau, MPH)

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.

Clinical Trials

Clinical Trials Clinical Trials Cardiology Trials

Potential Options for Better Heart Health: Join This Research Study!

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.

Research

Research Cardiology Clinical Trials Clinical Trials

PI Savors Opportunity to Advance Medicine

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.

Medicine

Medicine Cardiology Clinical Research Clinical Trials

Digital interventions cut heart failure mortality, study shows

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

Clinical Trials

Clinical Trials Clinical Trials Cardiology Compliance

Gender parity & heart failure research: Female authors could mean more female participants

Scienmag

AUGUST 16, 2020

The […].

Cardiology

Cardiology Research Clinical Trials Clinical Trials

Velocity Expands to 17 Sites in Europe

Velocity Clinical Research

JANUARY 3, 2024

The acquisition of KO-MED is Velocity’s first foray into Oncology research, which accounts for roughly 40-50% of clinical trials globally. KO-MED has been the leading multi-site network in Poland since 2020, having enrolled over 9,000 patients into clinical research.

Clinical Trials

Clinical Trials Clinical Trials Clinical Research Trials

Abbott’s New Leadless Pacemaker Receives FDA Approval for Slow Heart Rhythms

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.

FDA Approval

FDA Approval Clinical Trials Clinical Trials Cardiology

Introducing the new NIHR National Patient Recruitment Centres

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.

Clinical Trials

Clinical Trials Clinical Trials Life Science Clinical Research

Update on CHAMPION-ALS Phase III trial of Ultomiris in amyotrophic.

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.

Trials

Trials Clinical Trials Clinical Trials Cardiology

Bristol Myers Squibb to Demonstrate the Strength of its Growing Cardiovascular Portfolio at the American College of Cardiology’s 71st Annual Scientific Session

The Pharma Data

MARCH 22, 2022

New data, including two late-breaking clinical trial presentations on mavacamten and a new analysis of the GUARD-AF study, reinforce the company’s continued commitment to those living with cardiovascular disease. PRINCETON, N.J.–(BUSINESS 22), taking place in Washington, DC, and virtually, from April 2-4, 2022.

Clinical Trials

Clinical Trials Clinical Trials Cardiology Trials

Cleveland Clinic led trial shows drug effective in 96% of patients with recurrent pericarditis

Scienmag

NOVEMBER 16, 2020

ET, Monday, November 16, 2020, Cleveland: Cleveland Clinic researchers leading a global clinical trial have found that rilonacept, an FDA approved drug for other inflammatory diseases, resolved acute pericarditis episodes and reduced risk of […].

Trials

Trials FDA Approval Clinical Trials Clinical Trials

RHYTHM AI cleared for large trial of atrial fibrillation mapping tool

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.

Trials

Trials Clinical Trials Clinical Trials Clinical Development

Steroids during surgery may not be helpful for infants having heart bypass

Medical Xpress

NOVEMBER 7, 2022

5–7, 2022, is a global exchange of the latest scientific advancements, research and evidence-based clinical practice updates in cardiovascular science. The meeting, held in person in Chicago and virtually, Nov.

Clinical Trials

Clinical Trials Clinical Trials Trials Research

A drug costing less than €2 a day helps in.

The Pharma Data

AUGUST 30, 2021

This is the finding of a study by investigators at the Centro Nacional de Investigaciones Cardiovasculares (CNIC), published today in the Journal of the American College of Cardiology (JACC). The study is a prime example of collaboration between basic and clinical researchers.

Drugs

Drugs Cardiology Clinical Trials Clinical Trials

First drug for severe frostbite helps prevent amputation

Drug Discovery World

FEBRUARY 21, 2024

“This approval provides patients with the first-ever treatment option for severe frostbite,” said Norman Stockbridge, Director of the Division of Cardiology and Nephrology in the FDA’s Center for Drug Evaluation and Research. Group 1 received iloprost intravenously for six hours daily for up to eight days.

Drugs

Drugs Cardiology FDA Approval Trials

Diabetes drug can treat and reverse heart failure and reduce

Scienmag

NOVEMBER 13, 2020

Empagliflozin, a recently developed diabetes drug, can effectively treat and reverse heart failure in both diabetic and non-diabetic patients, according to researchers at the Icahn School of Medicine at Mount Sinai.

Clinical Trials

Clinical Trials Clinical Trials Drugs Medicine

Cardiol Therapeutics Announces Formation of Data Safety Monitoring and Clinical Endpoint Committees for Phase II/III Outcomes Trial in High-Risk Patients Hospitalized with COVID-19

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.

Trials

Trials Cardiology Containment Development

Introducing the new NHS Patient Recruitment Centres

pharmaphorum

OCTOBER 2, 2020

The five new NHS 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.

Clinical Trials

Clinical Trials Clinical Trials Life Science Clinical Research

Grand Rounds December 15, 2023: Diversifying Clinical Trials: A Path Forward (Roxana Mehran, MD, FACC, FAHA, MSCAI, FESC)

Velocity Launches Cardiology Council to Accelerate Research Excellence (CARE)

Trending Sources

January 17, 2024: In This Friday’s PCT Grand Rounds, Why Are Imaging Trials Different?

How the Ukrainian clinical trial industry is overcoming disruption

September 14, 2022: PCT Grands Rounds Will Explore Feasibility of National Registry-Based Pragmatic Trials

Heart and Kidney Health for All: Expanding Cardiovascular Clinical Trials to Include CKD Patients

Grand Rounds November 4, 2022: The CardioNerds Clinical Trials Network: Pairing Equitable Enrollment with Trainee Development (Amit Goyal, MD, MAS)

The Scientific Rationale for Diversity in Clinical Trials

Grand Rounds January 19, 2024: Why Are Imaging RCTs Different? Lessons From Chest Pain Evaluation Trials (Pamela S. Douglas, MD, MACC, FASE, FAHA)

November 22, 2022: ADAPTABLE Points to Need for Better Integration of Patient-Reported Health Data Into Pragmatic Trials

Grand Rounds June 2, 2023: PROACT Xa and The Wizard of Oz: Behind the Curtain of a Pragmatic Decentralized Clinical Trial (John Alexander, MD, MHS)

Cardiovascular Clinical Trials with Patient Diversity: Challenges and Considerations

Cardiac Biomarkers in Cardiovascular Clinical Trials: Caveats and Considerations

Grand Rounds August 11, 2023: The REMAP-CAP Adaptive Platform Trial: Recent Insights and Future Directions (Patrick Lawler, MD, MPH)

Grand Rounds September 16, 2022: Using Nationwide Registries to Conduct Pragmatic Randomized Trials: The DANFLU Program (Tor Biering-Sørensen, MD, PhD, MPH)

Velocity Clinical Research Expands to Poland

Heart failure drug to progress to Phase II trials

Clinical research business continues to expand in US

STAT+: Pharmalittle: Pfizer scaling back early-stage research into rare diseases; BioNTech and U.K. partner on cancer trials

Australian Research Study Looking at a Potential New Medication for Inflammation, in People with Heart Disease and Chronic Kidney Disease

Velocity Hosts Global CARE Council Summit

Clinical trial results address concerns about pharmacogenetic testing

Shifting the Narrative on Clinical Research at a Nevada Health System

“Nothing scares us” – Ukraine’s clinical research sector begins fearless recovery

Doctor Finds ‘Energizing’ Second Career as PI

Bayer to present new data from comprehensive finerenone clinical trial program

Grand Rounds February 9, 2024: Pragmatic Recruitment of Underrepresented Groups – Experience From the Diuretic Comparison Project (Cynthia Hau, MPH)

Potential Options for Better Heart Health: Join This Research Study!

PI Savors Opportunity to Advance Medicine

Digital interventions cut heart failure mortality, study shows

Gender parity & heart failure research: Female authors could mean more female participants

Velocity Expands to 17 Sites in Europe

Abbott’s New Leadless Pacemaker Receives FDA Approval for Slow Heart Rhythms

Introducing the new NIHR National Patient Recruitment Centres

Update on CHAMPION-ALS Phase III trial of Ultomiris in amyotrophic.

Bristol Myers Squibb to Demonstrate the Strength of its Growing Cardiovascular Portfolio at the American College of Cardiology’s 71st Annual Scientific Session

Cleveland Clinic led trial shows drug effective in 96% of patients with recurrent pericarditis

RHYTHM AI cleared for large trial of atrial fibrillation mapping tool

Steroids during surgery may not be helpful for infants having heart bypass

A drug costing less than €2 a day helps in.

First drug for severe frostbite helps prevent amputation

Diabetes drug can treat and reverse heart failure and reduce

Cardiol Therapeutics Announces Formation of Data Safety Monitoring and Clinical Endpoint Committees for Phase II/III Outcomes Trial in High-Risk Patients Hospitalized with COVID-19

Introducing the new NHS Patient Recruitment Centres

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