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What happens to a pragmatic trial intervention after the study ends? In a new article from the NIH Pragmatic Trials Collaboratory, investigators from 6 of the program's completed pragmatic clinical trials summarize the posttrial interpretation of their trials' results and consider the factors that influenced the sustainment or de-implementation of the studies' interventions.
Despite advancements in digitization and remote or decentralized trials, traditional clinical trials with a central site, in-person recruitment and monitoring, and paper-based or electronic regulatory submissions continue to remain critical […] The post Clinical Trial Success: ProRelix Research’s Tips for Sponsors appeared first on ProRelix Research.
Bringing clinical trials to patients has become easier with the advent of digital technologies and decentralised clinical trials (DCTs). Learn how the hybrid approach combining traditional and digital methods can benefit patients and advance medical research.
An online portal enabling people worldwide to find and express interest in clinical trials has been launched by Clinical Trial Media, a clinical trial participant recruitment and retention company.
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
basicsArentSoBasicWhitepaper Download The post The Basics Aren’t So Basic: Successful Participant Recruitment Requires Dedicated Time, Better Relationships, and Adequate Site Support appeared first on WCG.
Recruiting patients for clinical trials is a common challenge for study sponsors conducting research. For this reason, it is often a wise strategy to work with an agency that specializes in outreach. These agencies excel at helping sponsors achieve their research goals within defined timelines and budgets.
Sepehr Shojaei serves as the vice president of design solutions at Lightship, using his 15 years of experience in clinical research operations to champion a patient-centric approach.
Sepehr Shojaei serves as the vice president of design solutions at Lightship, using his 15 years of experience in clinical research operations to champion a patient-centric approach.
Written By: Derek Ansel, MS, CCRA, Executive Director, Therapeutic Strategy Lead, Rare Disease Given that 80% of rare diseases have a genetic etiology, genetic implications should be addressed at the onset of a clinical program to support trial enrollment. Many of the rare disease studies we support at Worldwide have a genetic etiology, and we discuss genetics and genetic testing with these sponsors.
The National Institutes of Pharmaceutical Education and Research (NIPERs) can consider their own in-house scientists for the new faculty positions or recruit pharmaceutical industry professionals for the Professor of Practice positions in the absence of suitable applications for faculty positions, recommends a study by the Department of Pharmaceuticals (DoP).
In this Friday's PCT Grand Rounds, Suresh Balu and Marc Sendak of Duke University will present "Advancing the Safe, Effective, and Equitable Use of AI in Healthcare." The Grand Rounds session will be held on Friday, January 26, 2024, at 1:00 pm eastern. Balu is the director of the Duke Institute for Health Innovation (DIHI) and the associate dean for innovation and partnership in the Duke University School of Medicine.
New details of the proposed acquisitions show there were multiple interested buyers, which, according to some analysts, could set the stage for more dealmaking.
According to Greek mythology, Zeus punished Prometheus for giving fire to humans. He chained Prometheus up and set an eagle to feast on his liver. Each night, the liver grew back and each day, the eagle returned for his feast. In reality, can a liver really grow back?
Ethics and regulatory onboarding documentation is now available for RAMP, one of the NIH Pragmatic Trials Collaboratory's newest pragmatic clinical trials. The documents include meeting minutes and supplementary materials summarizing recent discussions of ethics and regulatory issues associated with the study. The consultation took place by video conference and included representation from the study's principal investigator and study team, members of the NIH Collaboratory's Ethics and Regulatory
Wegovy, Ozempic and Mounjaro are weight loss and diabetes drugs that have made quite a splash in health news. They target regulatory pathways involved in both obesity and diabetes and are widely considered breakthroughs for weight loss and blood sugar control. [link] But do these drugs point toward a root cause of metabolic disease?
The opinion would allow Abecma to be prescribed after two standard therapies and is the latest sign of CAR-T’s growing use in earlier cancer treatment.
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.
Neuroscientists at Washington State University think they have figured out why cannabis is so notorious for causing the ‘munchies’ among users. Their research on mice is the first to investigate how cannabis impacts the real-time activity of brain regions that control appetite.
An 11-year-old boy born deaf can hear after receiving Lilly's genetic medicine. Others, including biotechs in China and Regeneron in the U.S., are taking aim at the same drug target.
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.
With a fatality rate 20 times that of COVID-19, and no vaccine, Disease X could swiftly bring humanity to its knees. Few would be left untouched by the pathogen were it to gain hold, causing healthcare systems to crumble and economies to collapse as the world once again tried to contain a force of nature.
CDMOs, who cater to the requirements of multiple companies and develop platform processes to achieve the much-needed economy of scale, are being seen as a possible solution.
The Central government’s actions to mandate licensing of all medical devices is posing a challenge to the industry, especially the micro and small enterprises in the sector, says the Surgical Manufacturers and Traders Association (SMTA), the pan India organisation of manufacturers and traders of surgical equipment for healthcare services providers in the country.
The NIH Pragmatic Trials Collaboratory this week published a new chapter in its Living Textbook of Pragmatic Clinical Trials. Part of the Living Textbook’s new ethics and regulatory collection, the chapter discusses the logistics of using a single IRB (sIRB). In 2016, the NIH issued a policy establishing the expectation that a “single IRB of record” will be used for all NIH-funded, multisite, human subjects research.
The sector’s first IPO of 2024 could be positive signal for the handful of other companies that have recently laid out plans for initial public offerings.
This new white paper defines and details the impact of Decentralized Clinical Trials on the Pharmaceutical industry and how the impact can be measured along with steps companies can take to ensure adoption.
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