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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.
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 clinicaltrials and for trials studying approved devices and drugs remains low. There are several strategies that will help increase diversity in CVD trials. Many high school and college students are moving away from the sciences. We have to change how we are practicing.
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.
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.
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].
To learn more about this important field of cardiovascular clinicalresearch, I invited Dr. Gregg Stone on the podcast. He completed his general cardiology fellowship at Cedars-Sinai Medical Center in Los Angeles, CA and subsequently a dedicated fellowship in advanced coronary angioplasty in Kansas City, MO.
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. Meanwhile, the TANDEM trial evaluated a fixed-dose combination of obicetrapib with 10 mg ezetimibe in a similar patient population.
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).
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
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.
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.
Yet, despite the overwhelming evidence linking CKD with this heightened cardiovascular risk, CKD patients are often underrepresented or outright excluded from cardiovascular clinicaltrials. Vice President of the Medical Department and Cardiology therapeutic lead, and Heather Lohr, Sr. Director of ClinicalTrial Management.
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 clinicalresearchtrial has found.
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.
“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.
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.
The summit focused on Velocity’s Diabetes + Obesity, MASH, Vaccine, Cardiology, and Women’s Health CARE Councils, along with a few areas in development. Learn more about the Velocity CARE Council approach > The post Velocity Hosts Global CARE Council Summit appeared first on Velocity ClinicalResearch.
Alnylam Pharmaceuticals announced promising results from its HELIOS-B Phase III clinicaltrial 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.
Vincent’s Hospital Location: 4th Floor Daly Wing, 35 Victoria Parade Fitzroy Lead Researcher: Prof Richard MacIsaac The Department of Endocrinology and Diabetes is part of the Tertiary Hospital of St Vincent’s Hospital Melbourne. Consisting of Nephrology and Cardiology, we are dedicated and hardworking teams. What’s Next?
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
When conducting clinicalresearch, investigators aim to control as many variables as possible so it is easier to examine the effectiveness of new treatments. However, this sometimes means strict requirements lead to only a narrow population of patients being eligible to be enrolled in a trial.
ET, Monday, November 16, 2020, Cleveland: Cleveland Clinicresearchers leading a global clinicaltrial have found that rilonacept, an FDA approved drug for other inflammatory diseases, resolved acute pericarditis episodes and reduced risk of […].
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.
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.
Michael Felker, MD, MHS, FACC, FAHA, FHFSA is Professor of Medicine with tenure in the Division of Cardiology at Duke University School of Medicine. He is Director of Cardiovascular Research at the Duke ClinicalResearch Institute and Vice-Chief for ClinicalResearch in the Division of Cardiology.
Heerspink, Professor of ClinicalTrials and Personalized Medicine and a clinical pharmacologist/trialist at the Department of Clinical Pharmacy and Pharmacology at the University center Groningen, Netherlands, and Co-Chair of the study’s Executive Committee.
December 2, 2020) – Clinicalresearch presented by Octapharma USA at the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition will highlight the investigational use of high-dose Octagam® 10% [Immune Globulin Intravenous (Human)] […].
” Howard said that the researchers “noticed that in old trials of statins — when half the patients took statins and half the patients took placebo — the side effects were almost identical for both groups. In all, 49 patients completed the year-long trial, making note of symptoms throughout the study period.
Introduction to Electronic Case Report Forms (eCRF) In the ever-evolving landscape of clinicaltrials, the transition from traditional paper-based case report forms to electronic Case Report Forms (eCRFs) has marked a significant advancement in how clinical data is collected, managed, and analyzed.
In recent years, the landscape of women’s health clinicaltrials has begun to shift. There is a growing recognition of the need for inclusive research that accurately reflects the diverse experiences of women. This disparity is even more pronounced among pregnant women, who are notably underrepresented in research.
Finding the right investigators for any given study is one of the most critical tasks in a clinicalresearch project. Societies such as the American Society of Clinical Oncology (ASCO) and the European Society of Cardiology (ESC) often have directories of members who are active in clinicalresearch (Brown, 2019).
based weight loss intervention in adults with obesity: A randomized clinicaltrial. ClinicalResearch Strategies for Fructose Metabolism. Journal of the American College of Cardiology. Measuring visceral and hepatic fat in clinical practice and clinicalresearch. DOI: 10.1155/2011/651936. .
Despite the growing consensus around the need for diversity in clinicaltrials, the industry still has a long way to go. 4,5 In fact, lack of representation in clinicaltrials compromises generalizability of research findings. Increasing Diversity in ClinicalTrials: Overcoming Critical Barriers.
NewAmsterdam Pharma announced promising results from its Phase III TANDEM clinicaltrial, evaluating a fixed-dose combination of obicetrapib and ezetimibe. The TANDEM trial enrolled 407 participants with baseline LDL-C levels averaging 97 mg/dL despite maximally tolerated statin use in 74 percent of patients.
Direct Access to High-Intent Audiences Pharma brands need to reach HCPs actively seeking information on new treatments, clinicalresearch, or patient management tools. Choosing the Right Keywords and Search Terms HCPs typically search for information related to disease management, clinicaltrials, and treatment guidelines.
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