Rethinking Clinical Trials
JANUARY 22, 2024
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.
ProRelix Research
JANUARY 23, 2024
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.
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pharmaphorum
JANUARY 23, 2024
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.
Outsourcing Pharma
JANUARY 22, 2024
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
WCG Clinical
JANUARY 24, 2024
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.
Antidote
JANUARY 25, 2024
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.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Worldwide Clinical Trials
JANUARY 24, 2024
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.
AuroBlog - Aurous Healthcare Clinical Trials blog
JANUARY 23, 2024
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).
Rethinking Clinical Trials
JANUARY 24, 2024
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.
Bio Pharma Dive
JANUARY 22, 2024
New details of the proposed acquisitions show there were multiple interested buyers, which, according to some analysts, could set the stage for more dealmaking.
Pharmaceutical Technology
JANUARY 24, 2024
Accent Therapeutics has raised $75m in a Series C financing round to progress the development of precision cancer therapies.
AuroBlog - Aurous Healthcare Clinical Trials blog
JANUARY 24, 2024
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?
Rethinking Clinical Trials
JANUARY 23, 2024
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
Bio Pharma Dive
JANUARY 23, 2024
A black box warning for secondary T cell malignancies should be added to the labeling of all six approved CAR-T therapies, the agency said.
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White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
Pharmaceutical Technology
JANUARY 24, 2024
The company could be in line for a priority review voucher if 4D-710, currently in Phase I/II clinical trials, is approved.
AuroBlog - Aurous Healthcare Clinical Trials blog
JANUARY 23, 2024
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?
Pharma Times
JANUARY 25, 2024
Around 50% of babies born with the condition are affected by heart defects
Bio Pharma Dive
JANUARY 26, 2024
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.
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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.
Pharmaceutical Technology
JANUARY 23, 2024
The UK MHRA has introduced further restrictions on the usage of fluoroquinolone antibiotics, strengthening the previous regulations.
AuroBlog - Aurous Healthcare Clinical Trials blog
JANUARY 22, 2024
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.
Fierce Pharma
JANUARY 22, 2024
As many have feared, the FDA’s investigation into secondary T-cell cancers following treatment with existing CAR-T therapies is poised to lead to a classwide black box warning. | As many have feared, the FDA's investigation into secondary T-cell malignancies following treatment with existing CAR-T therapies is poised to lead to a classwide black box warning.
Bio Pharma Dive
JANUARY 24, 2024
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.
Pharmaceutical Technology
JANUARY 22, 2024
Sandoz has agreed to acquire Coherus Biosciences' CIMERLI ophthalmology franchise, including proprietary software.
AuroBlog - Aurous Healthcare Clinical Trials blog
JANUARY 21, 2024
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.
Fierce Pharma
JANUARY 22, 2024
Even as Gilead looks to become an oncology powerhouse in the coming years, the company on Monday recorded a major setback for its antibody-drug conjugate (ADC) Trodelvy. | The antibody-drug conjugate did not significantly improve survival outcomes compared with a chemotherapy alone in previously treated patients with metastatic non-small cell lung cancer.
Bio Pharma Dive
JANUARY 22, 2024
Trodelvy didn’t outperform chemotherapy in a large study of people with a common lung tumor, a setback that sent company shares down by double digits.
Pharmaceutical Technology
JANUARY 21, 2024
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.
AuroBlog - Aurous Healthcare Clinical Trials blog
JANUARY 25, 2024
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.
Pharma Times
JANUARY 22, 2024
Approximately one in five children will be hospitalised to treat measles
Bio Pharma Dive
JANUARY 24, 2024
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.
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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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