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Biomarkers are indispensable tools in clinicaltrials, providing critical insights that enhance the efficiency and precision of drug development. Our biomarker testing capabilities, offered across BioA and Clinical Pharmacology Unit (CPU) sites, provide a comprehensive and tailored approach to biomarker analysis.
Yet enrollment of ethnic minorities in NIH clinicaltrials and for trials studying approved devices and drugs remains low. Increasing diversity in trial leadership is one of the most important strategies to increase diversity among RCT participants. CVD is the leading cause of mortality in women.
Clinicaltrials 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].
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 clinicaltrials.
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. The post January 17, 2024: In This Friday’s PCT Grand Rounds, Why Are Imaging Trials Different?
James and Oldgren are professors of cardiology in the Department of Medical Sciences and the Uppsala ClinicalResearch Center at Uppsala University. The post June 12, 2024: Registry-Based DAPA-MI Trial to Be Featured in This Week’s PCT Grand Rounds appeared first on Rethinking ClinicalTrials.
Each year, FDA selects a limited number of clinicaltrials to fund to help sponsors pursue development of medical products for rare diseases and advance their field. In October, FDA announced seven new clinicaltrial grants awarded in fiscal year (FY) 2024 – including one for a Phase 3 trial – totaling $17.2
Dr. Biering-Sørensen is professor and head of the Center for Translational Cardiology and Pragmatic Randomized Trials at the University of Copenhagen and head of the Cardiovascular Non-Invasive Imaging Research Laboratory at Copenhagen University Hospital – Herlev and Gentofte. Join the online meeting.
To learn more about this important field of cardiovascular clinicalresearch, 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.
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) clinicaltrials. In CV clinicaltrials, cardiac biomarkers are most commonly included in efficacy and safety endpoints.
The findings highlight the need for better integration of patient-reported health data into pragmatic research studies. Results of the study were published in JAMA Cardiology. Patient-reported health data can assist investigators in capturing clinical events in pragmatic clinicaltrials.
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.
The pragmatic elements were already in place so when COVID happened the main thing that had the biggest impact on our study was the shortage of study coordinators that effected every trial, and a few of our study sites went under due to difficulty of staffing and sustaining a research enterprise.
An analysis of 10 clinicaltrials 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
… 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.,
Researchers also need to ask what is the optimal CTA intervention and should downstream care be required? Lessons From Chest Pain Evaluation Trials (Pamela S. Douglas, MD, MACC, FASE, FAHA) appeared first on Rethinking ClinicalTrials. There are considerations for the flexibility of the intervention.
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 ClinicalTrials. Key Points.
Cardiovascular clinicaltrials 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 clinicaltrials. In the same webinar, Dr. Hansie M.
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.
Clinicaltrials generally assume homogenous treatment effects; in reality there are heterogeneous treatment effects. The trial shortened the divide between clinical care and research and demonstrated a capacity for “parabiosis” with other trials in a multiple-platform trial.
Velocity ClinicalResearch, 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).
XTALKS WEBINAR: Cardiac Safety Solutions in Decentralized ClinicalTrials (DCT). Register for this webinar to learn why cardiac safety testing is critical for clinicaltrial participants. The featured speakers will discuss why at-home data collection and analyses must be comparable to in-clinic testing.
The five new NIHR National Patient Recruitment Centres (NPRCs) are set to shape the future of commercial clinicaltrials 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.
This expanded clinicalresearch 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 clinicaltrial awareness at the time of the affiliation agreement.
DCP learned that leveraging health systems for large-scale clinicaltrials is feasible. There was a lot of work that went into startup, making sure incentives were aligned across the VA system, meetings with primary care, cardiology, the VA ethics office, and ultimately with the central IRB.
In a randomized, controlled clinicaltrial, 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.
Bayer will present new renal and cardiovascular (CV) analyses from the comprehensive finerenone (Kerendia®) clinicaltrial 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.
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.
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.
“Without clinicalresearch, 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 clinicaltrialresearch work in heart health, noting most new drugs never make it to market.
Menarini Group has announced positive topline data from the Phase III BROADWAY and TANDEM clinicaltrials, evaluating obicetrapib and the fixed-dose combination of obicetrapib with ezetimibe.
It’s easy to hear the enthusiasm for clinicaltrials 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. Clinicalresearch remains a key component of healthcare, he stresses. “A
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.
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 (..)
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.
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, […].
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.
In a clinicaltrial of 60 patients, led by researchers at Imperial College London and clinicians at Imperial College Healthcare NHS Trust, 90 per cent of symptoms experienced by patients whilst taking statins were all present when they took placebo pills. […].
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.
New data, including two late-breaking clinicaltrial 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.
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 clinicalresearchers.
The acquisition of KO-MED is Velocity’s first foray into Oncology research, which accounts for roughly 40-50% of clinicaltrials globally. KO-MED has been the leading multi-site network in Poland since 2020, having enrolled over 9,000 patients into clinicalresearch.
The five new NHS Patient Recruitment Centres (NPRCs) are set to shape the future of commercial clinicaltrials 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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