Sat.Jan 06, 2024 - Fri.Jan 12, 2024

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The Year Ahead in Trends, Challenges, and Opportunities for Clinical Trial Sites

ACRP blog

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,”

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Uptick in Clinical Trial Complexity: How Can You Achieve Your Clinical Trial Objectives Faster?

XTalks

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.

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Fortrea, Advarra and Veeva form partnership to 'dramatically simplify' clinical trial process

Outsourcing Pharma

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.

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Medable - reimagining the way clinical trials are deployed and cutting trial build times by half

Outsourcing Pharma

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.

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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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January 8, 2024: Pragmatic Trials Researchers Share Lessons From Collecting Patient-Reported Outcomes in the Electronic Health Record

Rethinking Clinical Trials

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.

Trials 298
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Patient Engagement Collaborative Announces Eight New Members

CTTI (Clinical Trials Transformation Initiative)

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.

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Pending FDA Clinical Trial Diversity Requirements

Imperical Blog

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.

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January 11, 2024: BeatPain Utah Study Team Uses Implementation Mapping Approach to Plan Hybrid Trial

Rethinking Clinical Trials

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.

Trials 147
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Backed by billionaires, a new biomedical institute tests an unorthodox approach

Bio Pharma Dive

Arena BioWorks, which will be led by Harvard University scientist Stuart Schreiber, seeks to blend academic and venture capital drug research models.

Scientist 321
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Sustainability in milling: A greener future for 2024?

Pharmaceutical Technology

With micronisation required for 30% of APIs on the market, there is a need for more sustainable methods of milling these vital drug products.

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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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Our Perception of Time Can Actually Speed Up Wound Healing

AuroBlog - Aurous Healthcare Clinical Trials blog

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.

Research 220
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Grand Rounds Biostatistics Series January 5, 2024: Methods for Handling Missing Data in Cluster Randomized Trials (Rui Wang, PhD; Moderator: Fan Li, PhD)

Rethinking Clinical Trials

          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

Trials 287
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JPM24: Pfizer’s tough sell, the next Karuna and building a biotech platform

Bio Pharma Dive

Albert Bourla acknowledged Pfizer’s difficult 2023, while a biotech CEO spoke with BioPharma Dive about building neuroscience startups.

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Vertex’s CASGEVY therapy gains approval in Saudi Arabia

Pharmaceutical Technology

Vertex Pharmaceuticals has announced the approval of CASGEVY (exagamglogene autotemcel [exa-cel]), the first CRISPR/Cas9 gene-edited therapy.

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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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Use These Three Mind Hacks to Avoid Temptation When Eating Healthily

AuroBlog - Aurous Healthcare Clinical Trials blog

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.

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January 10, 2024: In This Friday’s PCT Grand Rounds, a Lottery for Allocating Scarce COVID-19 Resources

Rethinking Clinical Trials

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.

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JPM24: Nvidia’s AI dreams, Sarepta’s rosy outlook and Jeff Jonas’ new job

Bio Pharma Dive

The chip maker struck a new deal with Amgen on Monday, while Sarepta brought news of strong sales to the J.P. Morgan Healthcare Conference.

Sales 312
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Novo Nordisk spends up to $1.64bn on US biotech startups

Pharmaceutical Technology

Novo Nordisk taps Flagship Pioneering portfolio companies Omega Therapeutics and Cellarity as obesity drugs competition intensifies.

Drugs 246
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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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Eating Late Can Change How You Burn Calories And Store Fat, Depressing Study Shows

AuroBlog - Aurous Healthcare Clinical Trials blog

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.

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January 9, 2024: Ethics Consultation Documents Now Available for iPATH Trial

Rethinking Clinical Trials

Ethics and regulatory onboarding documentation is now available for iPATH, 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 Regulator

Trials 147
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5 questions facing pharma in 2024

Bio Pharma Dive

Many drugmakers hope to compete in obesity, while others seek to win oncology’s next era. In the background, a contentious drug pricing law looms.

Drugs 294
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CureVac announces positive Phase II Covid-19 vaccine trial data 

Pharmaceutical Technology

The CureVac and GSK Covid-19 collaboration was first announced in February 2021, with regulatory discussions already in motion.

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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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New Class of Antibiotic Found That Kills Deadly Drug-Resistant Superbug

AuroBlog - Aurous Healthcare Clinical Trials blog

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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How To Become a Substance Abuse Counselor

Pharma Mirror

Embarking on a career as a substance misuse counselor is both a noble and challenging path. This role demands a deep understanding of psychological principles, empathy, and the determination to support others through their recovery journey. Keep reading to discover the steps required to build a successful career in this field. Understanding the Role of a Substance Addiction Counselor Substance addiction counselors are professionals who specialize in helping people overcome addictions to drugs, a

Drugs 130
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Biogen CEO sees progress in launch of Alzheimer’s drug Leqembi

Bio Pharma Dive

At the J.P. Morgan Healthcare Conference Monday, company head Chris Viehbacher said insurance reimbursement is now ‘not an issue’ for treatment.

Drugs 275
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FDA grants approval for Ligand’s molluscum contagiosum treatment

Pharmaceutical Technology

The FDA has granted approval for Ligand Pharmaceuticals’ Zelsuvmi (berdazimer topical gel, 10.3%) for molluscum contagiosum.

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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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A Crash Diet Could Be a Seriously Bad Idea For Weight Loss

AuroBlog - Aurous Healthcare Clinical Trials blog

Those trying to kick-start their weight loss or perhaps wanting to lose a few pounds before a big event or holiday may be tempted to try a crash diet.

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JPM24: Pfizer CEO promises 'year of execution' after recent struggles, Seagen buyout

Fierce Pharma

Pfizer knows it had a bad year in 2023. Speaking to reporters at the 2024 J.P. | Pfizer knows it had a bad year in 2023. Speaking to reporters at the 2024 J.P. Morgan Healthcare Conference on Monday, the company’s CEO, Albert Bourla, spoke bluntly about the hits the company took, and he acknowledged the underperformance of certain key launches.

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Merck pays $680M for struggling cancer biotech Harpoon

Bio Pharma Dive

The acquisition will build out Merck’s pipeline of immunotherapies as its top-seller Keytruda nears the end of U.S. market exclusivity.

Marketing 268
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FDA allows Florida to import medicines from Canada

Pharmaceutical Technology

The US FDA has granted authorisation for Florida's drug importation programme under section 804 of the FD&C Act.

Medicine 246
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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.