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The surge in MASH cases stresses the need for early diagnosis, timely intervention and precise, reliable methodologies in clinicaltrials to evaluate new therapies effectively. Read on to gain insights from Medpace experts about advancements in imaging, histology and innovative techniques for MASH clinicaltrials.
Researchers analyzed the electronic health records of more than 18,000 US patients between May 2022 and September 2023 to compare outcomes among those receiving the two injected medicines, and published the […]
Clinicalresearch is a vital driver of medical progress. Yet, many people are unaware of the essential role of institutional review boards (IRBs) in protecting clinicaltrial participants by ensuring compliance with human subject protection requirements. It is the foundation of medical innovation.
Following the success of Issue 3 , which focused on the critical importance of patient diversity in clinicalresearch, Xtalks is thrilled to announce Xtalks Clinical Edge Issue 4. These prominent leaders will share their experiences, strategies and visions about whats next for clinicalresearch.
Fortunately, advances in clinicalresearch are providing hope for better treatments and outcomes. With the support of global networks like ours at Worldwide ClinicalTrials (Worldwide), autoimmune and bone health research is accelerating, providing new solutions to patients around the world.
Some scientists suspect these neural knots can harm and even kill brain cells, but so far in clinicaltrials, drugs that have tried to target the tangles have shown limited success. A promising new medicine has now […]
Over the past decade, Germany’s share of global clinicaltrial activities has dropped year on year. of trials in 2021 , down from 7.2% Aiming to revitalize the country’s pharmaceutical industry, it signaled a shift from policymakers on clinicalresearch and drug development issues.
Fortunately, advances in clinicalresearch are providing hope for better treatments and outcomes. With the support of global networks like ours at Worldwide ClinicalTrials (Worldwide), autoimmune and bone health research is accelerating, providing new solutions to patients around the world.
Researchers see a greater need for new generation therapeutics to propel precision medicine. The development of innovative therapeutic approaches in healthcare encompass a variety of fields, including gene therapy, personalized medicine, immunotherapy, and advanced biologics.
Clinicaltrials have been steadily leaving the UK for years. of patients recruited to global trials were from the UK. Thats not to say we dont still have some clout (the UK ranks fourth globally for Phase II trials ), but the trending outflow needs to be addressed. In 2021, just 2.2%
In this Friday’s PCT Grand Rounds, Adrian Hernandez and Christopher Lindsell of Duke University will present “Virtual Vigilance: Monitoring of Decentralized ClinicalTrials.” He also serves as co-principal investigator of the NIH Pragmatic Trials Collaboratory Coordinating Center. Join the online meeting.
Late last year, pharmaphorum spoke with AstraZeneca’s Ben Challis, VP and head of translational science and experimental medicine, cardiovascular, renal, and metabolism (CVRM), together with Magnus Jörnten-Karlsson, executive director of Unify. Unify, launched in December 2020, is AstraZeneca’s patient app and clinicaltrial support tool.
Institutional review boards (IRBs) play a crucial role in the ever-evolving field of clinicalresearch. Innovations in fields such as immunotherapy, cancer and chronic diseases owe their existence to clinicaltrials, which judiciously test and evaluate safety and efficacy.
Hernandez is a professor of medicine and director of the Duke ClinicalResearch Institute at Duke University; he is a co–principal investigator of the NIH Pragmatic Trials Collaboratory Coordinating Center. Dr. Lipset is cochair of the Decentralized Trials & Research Alliance. Join the online meeting.
Biology is opening up new frontiers in medicine. We are witnessing a revolution in healthcare, driven by advances in genetics, Omics, RNA and CRISPR gene-editing technology, to deliver precision and personalised medicine, said Kiran Mazumdar-Shaw, executive chairperson, Biocon and Biocon Biologics.
Barry Mangum talks the importance of pediatric research, its evolution over the years, and the obstacles and opportunities that the industry faces as it moves forward. How long have you been in pediatric clinicalresearch, and how did you enter the field? So I’ve been working in that space about 43 years.
In the increasingly advancing world of medicine, personalized care is a key factor that can progress your drug development efforts. One way to ensure customized disease management is to utilize pharmacogenomics (PGx) in your clinicaltrial. Reduces Trial Failures Oftentimes, clinicaltrials may fail due to a lack of efficacy.
A special series of articles addressing pragmatic and virtual trials appears this week in the journal Contemporary ClinicalTrials and offers practical approaches to the many challenges clinicaltrials face. The special issue can be found on the Contemporary ClinicalTrials website.
What Are Pragmatic ClinicalTrials? Description In this video, Dr. Lesley Curtis describes pragmatic clinicaltrials. The post What Are Pragmatic ClinicalTrials? The post What Are Pragmatic ClinicalTrials? appeared first on Rethinking ClinicalTrials.
The Psychedelic Community Casts a Wide Net Along with a robust community of scientific researchers and medical practitioners, Psychedelic Science included artists, educators, religious and cultural leaders, philanthropists, patient and policy advocates, and many more.
This week, the Medicines and Healthcare products Regulatory Agency (MHRA) is introducing major changes to clinicaltrial regulation in the UK with expedited timelines at several stages. The MHRA hopes this new framework “will remove obstacles to innovation” and “streamline the regulation of clinicaltrials” amongst other things.
By focusing on clinical excellence, comprehensive education, and cutting-edge research, the Arya Vaidya Pharmacy Research Foundation (AVPRF) based in Coimbatore is ensuring that ayurvedic practices are validated, credible, and relevant for future generations.
She celebrates how healthcare professionals have an exceptional power to transform lives, and will share her perspective on how compassionate care can be incorporated into clinicalresearch in a Signature Series keynote session tailored for attendees of ACRP 2025 in New Orleans, La., My life has been immersed in the field of medicine.
Clinicaltrials in drug development are a vital part of the process to bring new medicines to patients. We have recognized this need and offer flexible and fast services that can be custom tailored, specifically to meet all study protocols.
Clinicaltrials in drug development are a vital part of the process to bring new medicines to patients. We have recognized this need and offer flexible and fast services that can be custom tailored, specifically to meet all study protocols.
Clinicaltrials in drug development are a vital part of the process to bring new medicines to patients. We have recognized this need and offer flexible and fast services that can be custom tailored, specifically to meet all study protocols.
Clinicaltrials in drug development are a vital part of the process to bring new medicines to patients. We have recognized this need and offer flexible and fast services that can be custom tailored, specifically to meet all study protocols.
Learn more Visit [link] Discussion Themes – What experts are being convened for the different trials? We have people with experience with post-viral symptoms, treating ME/CFS, general COVID knowledge, biomarker experience, clinicaltrials, patient-reported outcomes, and more. It’s all over the place.
To guide sponsors, investigators, CROs, and other parties in clinicalresearch, the European Medicines Agency (EMA) has consolidated the contemporary requirements for using computerized systems and electronic data in clinicaltrials.
Building a Study Team for a Pragmatic ClinicalTrial Description NIH Collaboratory investigator Dr. Lesley Curtis shares tips for building effective study teams for pragmatic clinicaltrials.
Amidst a shifting clinical landscape characterized by increasingly complex trial designs and growing patient subpopulations, many contract research organizations (CROs) have adopted a “one-stop-shop” strategic approach. Moreover, these delays impact getting potentially lifesaving therapies to patients in need.
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].
Joseph Ross In this Friday’s PCT Grand Rounds, Joseph Ross of Yale University will present “The Yale Open Data Access (YODA) Project: 10 Years of ClinicalTrial Data Sharing.” The YODA Project promotes open science, research transparency, and the sharing of clinicalresearch data to support healthcare research.
Yet enrollment of ethnic minorities in NIH clinicaltrials and for trials studying approved devices and drugs remains low. Further efforts are urgently needed to increase diversity in the cardiology workforce, which will improve clinicaltrial diversity and cardiovascular health for all.
Whether it’s for a treatment for a chronic ambulatory condition, precision medicine or cell and gene therapy, there is a massive uptick in clinicaltrial complexity. It’s important to make sure that with this increase in clinicaltrial complexity, we don’t make our trials overly burdensome to sites or patients,” says Markham.
BlueRock Therapeutics, a subsidiary of Bayer AG, is making waves in the treatment of Parkinsons disease by advancing its investigational cell therapy, bemdaneprocel, to a Phase III clinicaltrial. In the Phase I trial, 12 participants received the therapy and were observed for two years. As of 2023, there were approximately 2.7
The pharma companies’ thrust on R&D to develop better medicines and the demand in hospitals for advanced medical technologies driven by artificial intelligence, remote patient monitoring and wearables are transforming patient care.
The European Medicines Agency (EMA) has adopted E6(R3) Principles and Annex 1 to take effect on July 23, 2025, and other ICH member nations and regions are still in the process of adopting E6(R3). No word yet on whether FDA will issue guidance endorsing the final ICH E6(R3). Below, we explore some of the key themes seen in the changes.
Also sharing advice on breaking free of unproductive habits on Saturday was Suzanne Kincaid, CCRA, ACRP-PM, FACRP, Consultant and Owner of Responsibility Research, in her session on “The Intersection of Technology and People: Harnessing Technology to Increase Efficiency and Build Relationships.” On Day Two of ACRP 2024 in Anaheim, Calif.,
But before pharmaceutical companies can go to market with a breakthrough drug, they need to ensure safety and efficacy through clinicaltrials. Pharma R&D teams are solving this problem by leveraging the power of artificial intelligence (AI) in clinicaltrials to save time and money.
There is a growing concern about the lack of stringent norms on disposal of unused and expired medicines that pose a threat to health and the environment. The key issue is the lack of dedicated guidelines on the disposal under the Drugs & Cosmetics Act.
The face of clinicalresearch is evolving. Rather than bringing patients to sites, study teams are now exploring ways they can bring the trial to patients using a varying combination of direct-to-patient drug shipments, home nursing, video conferencing, and electronic data collection. Everybody got used to doing things remotely.
Almost everyone I’ve met in clinicalresearch has accidentally discovered this hidden profession. Your interest in science and medicine somehow got you involved in clinicalresearch and clinicaltrial management. ClinicalResearch is sometimes also referred to as Medical Affairs or Clinical Affairs.
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