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Its becoming more expensive and time-consuming to move a drug from the clinical trial stage to approval. Patient recruitment is the leading driver of costs in clinical trials, and 55% of trials that fail to complete cite low accrual rate as the reason for study termination.
Jonas Oldgren In this Friday’s PCT Grand Rounds, Stefan James and Jonas Oldgren of Uppsala University will present “DAPA-MI – A Pragmatic Registry-Based Double-Blind RCT Trial Designed for Regulatory Evaluation.” ” The Grand Rounds session will be held on Friday, June 14, 2024, at 1:00 pm eastern.
Eli Lilly shared new Phase II trial data showing that its experimental siRNA therapy, lepodisiran, leads to reductions in levels of lipoprotein(a) (Lp(a)) a genetically inherited risk factor for heart disease in adults with elevated levels of the marker. The 400 mg dose was the highest lepodisiran dose in the trial.
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. Join the online meeting.
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.
Through the implementation of full automation in bioanalytical testing PK, immunogenicity, and biomarker assays we streamline trials, reduce costs, save time, and maintain the highest data quality standards. Biomarkers support adaptive trial designs, allowing modifications based on interim results to optimize study outcomes.
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.
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.
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.
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].
To learn more about this important field of cardiovascular clinical research, 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.
… 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.,
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.
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
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).
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.
This includes new Phase III trial data for Kerendia (finerenone) in patients with heart failure that was presented recently at this year’s European Society of Cardiology (ESC) Congress 2024. Tune into the episode to hear more about the latest trial data for finerenone in heart failure and the landscape of heart failure research.
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.
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.
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.
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.
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).
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.
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.
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. Webinar attendees will also learn how BioTel Research is making waves in cardiac safety testing.
“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 trialresearch work in heart health, noting most new drugs never make it to market.
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.
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 (..)
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, […].
Performing open bypass surgery to restore circulation for people with a severe form of peripheral artery disease (PAD)—a condition that limits blood flow to the legs and feet—resulted in better outcomes for specific patients compared to a less-invasive procedure, a National Institutes of Health-supported clinical researchtrial has found.
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.
Positive high-level results from the FoCus Phase III trial in Wilson disease showed ALXN1840 met the primary endpoint with a statistically significant improvement in daily mean copper mobilisation from tissues, demonstrating superiority compared with standard-of-care (SoC) treatments.
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
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.
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.
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.
Annual scientific symposium of CRF will take place virtually October 14-18 NEW YORK – September 17, 2020 – The Cardiovascular Research Foundation (CRF) has announced over 30 late-breaking trial and science presentations that will be reported at TCT Connect.
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.
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 […].
This early-stage trial is set to enroll ten patients across the US and Canada, with its primary aim to evaluate the safety and tolerability of DA01 cell transplantation at one year post-transplant. BlueRock Therapeutics secures FDA fast track for Parkinson’s disease cell therapy.
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.
MorphoSys in-licensed Monjuvi, which is a humanized Fc-engineered monoclonal antibody against CD19 – the same protein which CAR-T cell therapies target and is in abundance in cancerous B cells, from Xencor in 2010 and is under evaluation in B-cell malignancies in several ongoing combination trials.
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