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Eisai and the National Cancer Center have signed an agreement to partner on investigator-initiated clinicalresearch for the anti-cancer agent, tazemetostat (Tazverik Tablets 200 mg), based on the Patient-Proposed Healthcare Services system.
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.
says David Vulcano, LCSW, MBA, CIP, RAC, FACRP , Vice President, ClinicalResearch Compliance and Integrity, at HCA Healthcare and author of a recent ACRP White Paper on Responsible Oversight of Artificial Intelligence for ClinicalResearch Professionals. in April.
Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist
What will the future hold for clinicalresearch? This new guidance will clearly impact the clinicalresearch field, but how? Learning Objectives: Dose-response curves and patient treatment: How do pharmacologic and toxicologic principles apply to the dosing of drugs in clinical development?
In a recent webinar, Challenges of Drug Development in Early Parkinsons Disease , Tom Babic, MD, PhD , our Vice President of Scientific Solutions in Neuroscience, uses his 40+ years of experience to share invaluable insights into the current state and future directions of early Parkinsons disease (PD) research.
Food and Drug Administration (FDA) is highly supportive of clinical trial innovation, including advancing study design, conduct, and reporting within the global ecosystem. A key question is what kind of behavior changes can help us improve as clinicalresearch professionals? appeared first on ACRP.
Fortunately, advances in clinicalresearch are providing hope for better treatments and outcomes. With the support of global networks like ours at Worldwide Clinical Trials (Worldwide), autoimmune and bone health research is accelerating, providing new solutions to patients around the world.
Clinicalresearch is a vital driver of medical progress. Yet, many people are unaware of the essential role of institutional review boards (IRBs) in protecting clinical trial participants by ensuring compliance with human subject protection requirements. Food & Drug Administrations standard for safety and efficacy.
Clinicalresearch has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management.
Fortunately, advances in clinicalresearch are providing hope for better treatments and outcomes. With the support of global networks like ours at Worldwide Clinical Trials (Worldwide), autoimmune and bone health research is accelerating, providing new solutions to patients around the world.
This variability not only poses challenges for diagnosis but also stresses the need for targeted research and innovative therapeutic approaches. By exploring rare diseases and focusing on HPP, we can better understand the complexities of genetic disorders and the need for patient-centric research and collaboration.
Clinicalresearch involves trial and error as part of the drug development process. Learn more about how to optimise drug trials and the important role of participants in clinicalresearch.
India has taken centre-stage in clinical trials for HIV/AIDS drug as there are several ongoing clinical trials in India focused on advancing HIV treatment. These trials are investigating new drug candidates, therapies, and approaches to manage HIV more effectively and potentially cure it.
If theres one thing clinicalresearchers can count on when it comes to regulations and guidance from governing bodies, its change. Its a unique opportunity to not only stay up to date with research initiatives, but also to engage with healthcare research professionals from around the country. This is a sponsored message.
In the fast-evolving field of clinicalresearch, thought leaders do more than just keep up; they lead the charge and shape the direction of the industry. Heres how thought leaders are currently making an impact in clinicalresearch: 1.
Trends in Psoriasis Research: Biologics, Biosimilars and New Therapies Recent innovations in biologics and biosimilars have transformed psoriasis care. Meanwhile, Innovent Biologics recently saw its New Drug Application (NDA) for picankibart, an IL-23p19 inhibitor, accepted by the Chinese National Medical Products Administration (NMPA).
For clinicalresearch professionals, this journey often involves reconciling differing feedback from regulatory agencies, each with unique standards, priorities, and expectations. Food and Drug Administration (FDA) Parallel Scientific Advice procedure, which aims to increase dialogue between the two agencies and sponsor companies.
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Partnering with a CRO that emphasizes the complexity of the patient’s voice and harnesses the nuances of clinical trial design is crucial for executing successful clinicalresearch. DEXA (Dual-Energy X-ray Absorptiometry) is the optimal method for accurately measuring body composition in clinicalresearch.
The Union health ministry has issued final notification defining the clinicalresearch organisations (CROs) and mandating registration for the organisations to operate under the New Drugs and Clinical Trials Rules (NDCTR), 2019. The New Drugs and Clinical Trials (Amendment) Rules, 2024, notified on September […]
Especially as we exited the blockbuster drug period of psychiatric development and trials were failing with huge placebo effects, I think we started realizing that the patients going into trials were not the real-world patients that were getting treated with drugs in the clinic.
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(nomadsoulphotos/Canva) A Korean study published recently suggests people with type 2 diabetes who are prescribed a particular class of drug might be at a significantly lower risk of dementia.
The psychedelic drug psilocybin (as found in ‘magic’ mushrooms) has promising potential as a treatment for the eating disorder anorexia nervosa, according to new research that looked at its effects on an animal model of the condition.
(Francesco Carta Fotografo/Moment/Getty Images) Migraines and headaches affect billions of people worldwide, and a new study suggests the drug ubrogepant can put a stop to the pain even before a migraine has fully kicked in.
The National Institute of Pharmaceutical Education and Research (NIPER) has underlined indispensability of artificial intelligence in pharmaceutical research. The applications of AI have enabled faster, more cost-effective, and data-driven approaches across the drug discovery and development lifecycle.
Patients taking Eli Lilly’s new drug Mounjaro achieved significantly greater weight loss than those on Novo Nordisk’s Ozempic, a head-to-head study published Monday showed.
The hypertension drug rilmenidine has been shown to slow down aging in worms, an effect that in humans could hypothetically help us live longer and keep us healthier in our latter years. Previous research has shown rilmenidine mimics the effects of caloric restriction on a cellular level.
Stephen Apps discusses how technology can help improve the speed and quality of clinicalresearch and why a dedicated, cross-functional approach is needed to maximize its value for smaller biotechs.
The hypertension drug rilmenidine has been shown to slow down aging in worms, an effect that in humans could hypothetically help us live longer and keep us healthier in our latter years. Rilmenidine was picked for this latest study because past research has shown it mimics the effects of caloric restriction on a cellular level. […]
These strategies are critical for enhancing the overall success of GLP-1 therapies in clinical practice. GLP-1 Drug Class: Market Overview The market for GLP-1 medications is expanding, with several establishing options and numerous promising therapies on the horizon.
Diversity, equity and inclusion (DEI) have become important elements in the landscape of clinicalresearch. Xtalks spoke with Stacy Weil, DHI, Senior Vice President, Business Operations and Patient Centricity, Premier Research, to gain insights into incorporating DEI practices and plans in clinicalresearch.
The EU AI Act’s implications extend into clinicalresearch, where AI is increasingly utilized for tasks like medical image analysis, natural language process for endpoint analysis, and generating/analyzing data for synthetic control arms. Here are some key requirements for “high risk” AI systems as they relate to clinical trials.
A large clinical trial in South Africa and Uganda has shown that a twice-yearly injection of a new pre-exposure prophylaxis drug gives young women total protection from HIV infection. All three medications […]
2024 has been a year of growth and evolution in clinicalresearch. These topics include perspectives on how artificial intelligence (AI) will be leveraged in clinicalresearch, key regulatory trends shaping the industry, the movements of site consolidation, the continued challenges (and potential solutions) of study startup, and more.
The growing attention to phytopharmaceuticals in the Indian lifesciences landscape is an opportunity to develop potent botanical extracts, said Dr. Vidhu Aeri, Professor of Pharmacognosy & Phytochemistry and former Dean, School of Pharmaceutical Education & Research, Jamia Hamdard, New Delhi.
The Central Drugs Standard Control Organisation (CDSCO) has released guidance for the companies to attain export No Objection Certificate (NOC) for manufacture of unapproved, banned or new drugs, a process which was centralised recently.
The US Food and Drug Administration (FDA) on Friday approved a highly anticipated new drug designed to slow cognitive decline in patients in mild and early stages of Alzheimer’s disease.
The Subject Expert Committee (SEC) which advises the national drug regulator on drug approvals and clinical trials has recommended grant of permission to drug major Astrazeneca for import and marketing of two strengths of anti-hyperkalaemia therapy drug Lokelma (sodium zirconium cyclosilicate for oral suspension).
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Dr K Sujith Kumar, the senior deputy drugs controller (DDC) at the department of drugs control administration (DCA) in Kerala has been appointed as the drug controller-in-charge of the state from Thursday, June, 1.
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