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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.
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.
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.
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?
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.
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.
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 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.
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.
Their discussion shows how meaningful partnerships, deep listening and unwavering patient-centricity can transform clinicalresearch, trial design and care delivery in rare conditions such as HPP. Fowler emphasized that active listening is critical to advancing patient-centric drug development.
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 […]
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.
If theres one thing clinicalresearchers can count on when it comes to regulations and guidance from governing bodies, its change. The Academy agenda covers: Human research protections U.S. Learn more about HCCA The post Keeping Up with the ClinicalResearch Compliance Landscape appeared first on ACRP.
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.
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.
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.
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 […]
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.
(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.
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 clinical trials, which judiciously test and evaluate safety and efficacy.
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.
(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 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).
In its efforts to streamline and rationalise the sampling procedure and maintain a centralised monthly database the Central Drugs Standard Control Organisation (CDSCO) has released the final version of the regulatory guidelines for sampling of drugs, cosmetics and medical devices by drugs inspectors of the Central and State drug authorities.
The US Food and Drug Administration (FDA) on Wednesday announced it had approved Eli Lilly’s highly anticipated weight loss drug Zepbound, the latest entrant in a field of powerful – and lucrative – new obesity medicines.
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.
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.
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. Rilmenidine was picked for this latest study because past research has shown it mimics the effects of caloric restriction on a cellular level. […]
Ketamine might be better known as a recreational drug or anesthetic. But there’s growing evidence for its use for people with hard-to-treat depression. An Australasian study out today [July 14] showed some positive results for people with treatment-resistant depression when they had ketamine injections.
Pharmaceutical giant Eli Lilly said Thursday it will seek approval to add its diabetes drug to the buzzy US weight loss market after achieving promising results in a new clinical trial. Tirzepatide, currently approved to treat type 2 diabetes under the name Mounjaro, is taken once a week as an injection. Eli Lilly said its […]
People who took a cheap diabetes drug after testing positive for COVID-19 had a 40 percent lower risk of getting long COVID, a US-based study said Friday.
A drug used to treat diabetes slowed the progression of motor issues associated with Parkinson’s disease, a study published in the New England Journal of Medicine said Wednesday. Parkinson’s is a devastating nervous system disorder affecting 10 million people worldwide, with no current cure.
One of the most consumed drugs in the US – and the most commonly taken analgesic worldwide – could do a lot more than simply take the edge off your headache. Acetaminophen, also known as paracetamol and sold widely under the brand names Tylenol and Panadol, also increases risk-taking, according to a study from 2020 […].
Empowering of the Central Drugs Standard Control Organisation (CDSCO) through centralisation of drug licensing may not be the path to improve the quality of drugs manufactured in the country both for domestic and international markets, says SME Pharma Industries Confederation (SPIC), the apex organisation of small and medium pharma industries in the (..)
The Central Drugs Standard Control Organisation (CDSCO) has released a list of 59 drug samples declared as Not of Standard Quality (NSQ) during the month of August, with samples of drugs labelled as manufactured by some of the major companies failing the quality test.
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.
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.
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.
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.
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