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Views from ACRP Members Topics highlighted include diversity and inclusion, decentralized clinical trial (DCT) elements, workforce challenges, and a possible role for sponsors and contract research organizations (CROs) in supporting outreach by sites based in diverse communities. Nadege Gunn: Need for study-agnostic funding for sites in diverse areas “The need for improved diversity of all kinds among trial participants will continue in 2024, with sponsor and CRO support critical to success,”
Getting a drug to market used to be a relatively simple and straightforward affair. That’s just not the case anymore. Whether it’s for a treatment for a chronic ambulatory condition, precision medicine or cell and gene therapy, there is a massive uptick in clinical trial complexity. Most Phase II and Phase III studies have around 20 endpoints and 263 procedures per patient.
Global contract research organization (CRO), Fortrea today announced an industry partnership with founding members cloud solutions company Veeva Systems Inc., and provider of clinical research technology, Advarra.
Medable Inc. has announced a new intelligent automation technology applied across its clinical trials platform it hopes will cut standard trial build timelines by at least half.
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!
In a new article from the NIH Pragmatic Trials Collaboratory, investigators from 6 of the program’s pragmatic clinical trials share case examples of the challenges they encountered in collecting patient-reported outcomes (PROs) in their trials and the strategies they used to address them. The article was published this week in Contemporary Clinical Trials.
Today, the U.S. Food and Drug Administration (FDA) and the Clinical Trials Transformation Initiative (CTTI) announced eight newly selected representatives for the Patient Engagement Collaborative (PEC). The group of 16 patients, caregivers, and patient group representatives meets with the FDA several times a year and discusses a variety of topics such as improving communication, education, and patient engagement related to medical product regulation.
Timely, accurate, and complete registration and reporting of summary results information for applicable clinical trials on ClinicalTrials.gov allows access to current research and evidence for all partners in the clinical trials enterprise, including patients, providers, sponsors and investigators, regulators, payers, and health system leaders. Despite the regulatory requirements for applicable clinical trials and the importance of fostering transparency while increasing knowledge of potential n
Timely, accurate, and complete registration and reporting of summary results information for applicable clinical trials on ClinicalTrials.gov allows access to current research and evidence for all partners in the clinical trials enterprise, including patients, providers, sponsors and investigators, regulators, payers, and health system leaders. Despite the regulatory requirements for applicable clinical trials and the importance of fostering transparency while increasing knowledge of potential n
Diversity in clinical trials is becoming mandatory, which can make drugs and devices more widely beneficial. New FDA regulations are coming; read on for our understanding of what to expect. Right now, almost a half million studies are registered on ClinicalTrials.gov, and about 65,000 are… The post Pending FDA Clinical Trial Diversity Requirements appeared first on Imperial Clinical Research Services Blog.
In a new article from the NIH Pragmatic Trials Collaboratory, the BeatPain Utah study team describes the "implementation mapping" they used to plan for trial implementation. The comprehensive, systematic approach enabled the team to craft an implementation plan for a complex telehealth intervention and to identify outcomes for evaluating the success of the implementation strategies.
Experts in the life-sciences industry are of the view that doing away with human studies for new drugs in India is unscientific and risky as patients here have different anthropometry.
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
Speaker Speaker: Rui Wang, PhD Associate Professor of Population Medicine and Associate Professor in the Department of Biostatistics, Harvard Pilgrim Health Care Institute and Harvard Medical School Moderator: Fan Li, PhD Assistant Professor of Biostatistics, Yale School of Public Health Slides Keywords Cluster-randomized; Intervention; Missingness; Outcomes Key Points Cluster randomized trials are trials in which clusters of individuals rather than independent individuals ar
It seems the time that wounds take to heal is partly down to mentality: researchers have found that healing happens faster when the person involved thinks that time is progressing more quickly than it actually is.
In this Friday's PCT Grand Rounds, Erin McCreary of the University of Pittsburgh will present "Design and Implementation of a Weighted Lottery to Equitably Allocate Scarce COVID-19 Resources." The Grand Rounds session will be held on Friday, January 12, 2024, at 1:00 pm eastern. McCreary is a clinical assistant professor of medicine at the University of Pittsburgh and the director of infectious diseases improvement and clinical research innovation at UPMC.
It’s a familiar start-of-the-year scene. You’ve committed to a healthier lifestyle and are determined that this time is going to be different. Your refrigerator is stocked with fruits and veggies, you’ve tossed out processed foods, and your workout routine is written in pen in your daily planner.
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.
A study suggests eating later in the day can directly impact our biological weight regulation in three key ways: through the number of calories that we burn; our hunger levels; and the way our bodies store fat.
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.
Researchers have identified an entirely new class of antibiotic that can kill bacteria that are resistant to most current drugs. Zosurabalpin is highly effective against the bacterium carbapenem-resistant Acinetobacter baumannii (Crab), which is classified as a “priority 1” pathogen by the World Health Organization due to its growing presence in hospitals.
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