Sat.Jan 20, 2024 - Fri.Jan 26, 2024

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January 22, 2024: Your Pragmatic Trial Has Ended. Now What?

Rethinking Clinical Trials

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.

Trials 162
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Clinical Trial Success: ProRelix Research’s Tips for Sponsors

ProRelix Research

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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Take the hybrid road to bring clinical trials to patients

pharmaphorum

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.

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Online portal launched to combat urgent need for more accessible ways to identify trial participants

Outsourcing Pharma

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.

Trials 81
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The New Age of Decentralized Clinical Trials

White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

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The Basics Aren’t So Basic: Successful Participant Recruitment Requires Dedicated Time, Better Relationships, and Adequate Site Support

WCG Clinical

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.

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How to work with a clinical trial patient recruitment agency

Antidote

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.

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Leveraging Genetic Testing for Enrolling Rare Disease Trials

Worldwide Clinical Trials

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.

Genetics 190
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NIPERs should consider ways to fill faculty positions in the absence of suitable applications: DoP study

AuroBlog - Aurous Healthcare Clinical Trials blog

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).

Scientist 201
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January 24, 2024: In This Friday’s PCT Grand Rounds, Healthcare AI That’s Safe, Effective, and Equitable

Rethinking Clinical Trials

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.

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Lilly gene therapy finding puts focus on hearing loss treatment pipeline

Bio Pharma Dive

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.

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Roles and Responsibilities of Specialized Clinical Supply Experts

When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.

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Inside the growing precision therapy market and the crucial role of pDNA manufacturing

Pharmaceutical Technology

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.

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Expert Reveals What Happens to Your Liver When You Quit Alcohol

AuroBlog - Aurous Healthcare Clinical Trials blog

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?

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January 23, 2024: Ethics Consultation Documents Now Available for RAMP Trial

Rethinking Clinical Trials

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

Trials 162
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Karuna, Cerevel might be just the start of psychiatry drug M&A

Bio Pharma Dive

New details of the proposed acquisitions show there were multiple interested buyers, which, according to some analysts, could set the stage for more dealmaking.

Drugs 310
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How Machine Learning Drives Clinical Trial Efficiency

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.

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Bladder cancer-focused CG Oncology files for IPO

Pharmaceutical Technology

On 18 January 2024, US-based biotech CG Oncology announced it was looking to raise $200m in an upcoming initial public offering (IPO), which will be the first for the biotech sector in 2024.

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Your Body Has a Built-in Weight Loss System You May Not Know About

AuroBlog - Aurous Healthcare Clinical Trials blog

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?

Drugs 194
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FDA wants classwide boxed warning on all commercial CAR-T therapies amid secondary cancer safety probe

Fierce Pharma

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.

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EMA recommends earlier use of Bristol Myers cell therapy for multiple myeloma

Bio Pharma Dive

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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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

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.

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Accent Therapeutics secures funding to advance cancer therapies

Pharmaceutical Technology

Accent Therapeutics has raised $75m in a Series C financing round to progress the development of precision cancer therapies.

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Scientists Think They’ve Figured Out How Cannabis Triggers The Munchies

AuroBlog - Aurous Healthcare Clinical Trials blog

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.

Scientist 190
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Merck's Keytruda extends life for kidney cancer patients after surgery, while Bristol's Opdivo fails again

Fierce Pharma

Merck’s unique approval for Keytruda as a postsurgical treatment for resectable kidney cancer has gained new backing in the form of data showing the PD-1 inhibitor can extend patients’ lives. | Merck’s unique approval for Keytruda as a postsurgerical treatment for resectable kidney cancer has gained new backing in the form of data showing the PD-1 inhibitor can extend patients’ lives.

Trials 128
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Gilead ADC medicine misses goal in closely watched lung cancer study

Bio Pharma Dive

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.

Medicine 293
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The New Age of Decentralized Clinical Trials

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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CAR-T therapies and cancer risk: No easy answers for the FDA

Pharmaceutical Technology

CAR-T cell therapies can provide durable cancer remission, however, a recent FDA investigation into reports of secondary T-cell malignancies has increased scrutiny of their risk profiles.

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Disease X: WHO Warns Future Outbreak Just a Matter of Time

AuroBlog - Aurous Healthcare Clinical Trials blog

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.

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What to know after a colon cancer diagnosis

Antidote

Colorectal cancer (often shortened simply to colon cancer) is the fourth-most commonly diagnosed cancer in the United States, and it is estimated that around 150,000 Americans are diagnosed each year. While the average age of diagnosis is 66, young adults are getting diagnosed in higher numbers every year, and researchers are still unsure as to why.

Research 122
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FDA orders new cancer warnings for CAR-T therapies

Bio Pharma Dive

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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Accelerating Clinical Supply Through Integrated Drug Development

As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.

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UK NICE recommends Pfizer’s talazoparib for advanced breast cancer

Pharmaceutical Technology

The UK NICE recommends Pfizer's talazoparib, marketed as Talzenna, to treat a specific type of locally advanced or metastatic breast cancer.

Marketing 245
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Licensing regime posing challenge to micro and small medical devices industry: SMTA

AuroBlog - Aurous Healthcare Clinical Trials blog

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.

Licensing 173
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World Cancer Day 2024: Trends in Oncology Research and More

XTalks

World Cancer Day 2024 is a global initiative that emphasizes the importance of heightened awareness about cancer. This day is observed annually on February 4th since its inception by the Union for International Cancer Control (UICC) in 2000. World Cancer Day is dedicated to encouraging early detection, prevention and treatment while also advocating for improved access to healthcare services for those affected by cancer.

Research 118
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CG Oncology prices larger-than-expected $380M IPO in hopeful sign for biotech

Bio Pharma Dive

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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Deliver Fast, Flexible Clinical Trial Insights with Spotfire

Clinical research 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. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.