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Sponsor and contract research organization (CRO) team members such as clinical research associates (CRAs), study managers, and startup specialists collaborate with research site teams to activate and execute clinical trials. Despite each stakeholders’ best efforts, there are persistent challenges regularly throwing studies off track and resulting in costly workarounds: Failure to achieve recruitment goals : About 20 to 50% of clinical trials will require “rescue”, where new sites are added
The report on the two-day virtual public meeting, “Mitigating Clinical Study Disruptions During Disasters and Public Health Emergencies (PHEs),” convened by the U.S. Food and Drug Administration (FDA) in collaboration with the Clinical Trials Transformation Initiative (CTTI), is now available. The meeting, which was held on October 18 and 19, 2023 with 720 global attendees, discussed recommendations provided by the FDA during the COVID-19 public health emergency to mitigate disruption of clini
The field of clinical research will witness significant advancements in 2024. From the continuing trend of the rapid adoption of AI tools to the growing use of real-world evidence (RWE) in regulatory decision-making and a focus on enhancing data integrity, find out how clinical trials will evolve in 2024 to shape the future of medical research. Read on to learn about the top 10 clinical trial trends for 2024, and be sure to explore and join upcoming webinars about clinical trials at Xtalks. 1.
Lupus, a complex autoimmune disease, has brought a substantial challenge to researchers and healthcare professionals. Understanding this condition and its various manifestations, as well as developing effective treatments, has been the focus of ongoing investigation in lupus clinical research for many years. In this pursuit, the importance of real-world data (RWD) in advancing lupus solutions cannot be overstated.
Speaker: Simran Kaur, Co-founder & CEO at Tattva Health Inc.
AI is transforming clinical trials—accelerating drug discovery, optimizing patient recruitment, and improving data analysis. But its impact goes far beyond research. As AI-driven innovation reshapes the clinical trial process, it’s also influencing broader healthcare trends, from personalized medicine to patient outcomes. Join this new webinar featuring Simran Kaur for an insightful discussion on what all of this means for the future of healthcare!
Dr. Pamela Douglas (Photo: Erin Roth, Duke Health) In this Friday's PCT Grand Rounds, Pamela Douglas of Duke University will present "Why Are Imaging RCTs Different? Lessons From Chest Pain Evaluation Trials." The Grand Rounds session will be held on Friday, January 19, 2024, at 1:00 pm eastern. 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 Echocardiograp
Oncology is recognized as having the largest drug pipeline of any therapeutic area. Estimates based on publicly available information suggest more than 40 percent of all new therapies in development are cancer treatments. Given this hotbed of activity, innovation in the space to drive faster decisions and more efficient trials is intense. There are many aspects of oncology drug development that are driven by the unique nature of the treatments being developed and the needs of the patients, their
The Cell and Gene Therapy Catapult (CGT Catapult), an independent organization specialising in the advancement of cell and gene therapies, has revealed that the UK has remained an attractive destination for commercial trials, with this type of clinical trial accounting for 81% of trials in 2023 and 80% in 2022.
The Cell and Gene Therapy Catapult (CGT Catapult), an independent organization specialising in the advancement of cell and gene therapies, has revealed that the UK has remained an attractive destination for commercial trials, with this type of clinical trial accounting for 81% of trials in 2023 and 80% in 2022.
Stay up to date on the latest clinical trials happening in the week of 8th-12th January. Get information on trials for Lytix Biopharma's Verrica, Celletcar, Ariceum, Dermavant, BI, and more.
Ethics and regulatory onboarding documentation for 2 of the NIH Pragmatic Trials Collaboratory's newest trials is now available. The documents include meeting minutes and supplementary materials summarizing recent discussions of ethics and regulatory issues associated with the AIM-CP trial and the MOMs Chat & Care Study. The consultations took place by video conference and included representation from the studies' principal investigators, members of the NIH Collaboratory's Ethics and Regulat
The startup is focusing on immune cells called Tr1 cells, which it claims could be important in treating autoimmune conditions like graft-versus-host disease.
Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.
The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven
A feral kitten in Omaha, Nebraska, tested positive for rabies in November 2023. It died of the raccoon variant of the virus, which is typically found only in the Appalachian Mountains.
The offering is the fifth outlined by a biotech startup this month, suggesting companies are becoming more willing to gauge investors’ appetite for new stock offerings.
Conventional wisdom would have us believe the journey to a long and healthy life begins with 10,000 steps. Each and every day. For those living a more sedentary lifestyle, it’s a goal that can take some effort to maintain. We’ve also known for some time it’s also almost certainly wrong.
The agency’s decision to expand use of Casgey, which won a landmark OK for sickle cell disease in December, comes more than two months ahead of schedule.
Even as the central government is expected to present its interim budget for 2024-25 in less than three weeks, the Medical Technology Association of India (MTaI) has urged the Union Finance Ministry to reduce the customs duty on certain devices. “India’s current tariff duty structure on medical device imports is very high.
Clinical trial data management is increasingly challenging as studies grow in complexity. Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. In this paper, we explore real-time data access and analysis for proactive study management. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.
The Union Ministry of Ayush (MoA) is taking steps to amend the Drugs and Cosmetics Act, 1940 to add the French Homoeopathic Pharmacopoeia and the European Pharmacopoeia under the standards on which the imports and manufacturing of homoeopathic drugs will be allowed in the country.
Phase 3 trial results showed Lutathera cut the risk of disease progression or death by 72% as initial treatment for gastroenteropancreatic neuroendocrine tumors, or GEP-NETs.
Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist
What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.
Parexel, one of the world’s largest clinical research organizations (CROs) providing the full range of Phase I to IV clinical development services, and the Japanese Foundation for Cancer Research (JFCR), the first and leading non-profit cancer research organization in Japan, has announced a strategic alliance to accelerate access to oncology clinical trials in Japan.
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