ACRP blog

JANUARY 10, 2024

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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Clinical Trials Clinical Trials Trials Clinical Research 64

XTalks

JANUARY 8, 2024

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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Clinical Trials Clinical Trials Trials Gene Therapy 105

Outsourcing Pharma

JANUARY 10, 2024

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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Clinical Trials Clinical Trials Clinical Research Trials 104

Outsourcing Pharma

JANUARY 9, 2024

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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Clinical Trials Clinical Trials Trials Clinical Development 111

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Clinical Supply

Rethinking Clinical Trials

JANUARY 8, 2024

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.

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Trials Clinical Trials Clinical Trials Research 286

CTTI (Clinical Trials Transformation Initiative)

JANUARY 9, 2024

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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Clinical Trials Clinical Trials Trials Regulation 124

Imperical Blog

JANUARY 9, 2024

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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Clinical Trials Clinical Trials Trials Clinical Research 59

Rethinking Clinical Trials

JANUARY 11, 2024

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.

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Trials Clinical Trials Clinical Trials Nurses 141

Bio Pharma Dive

JANUARY 12, 2024

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

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Scientist Drugs Research 315

Pharmaceutical Technology

JANUARY 8, 2024

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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Production Marketing Drugs 263

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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

Clinical Trials

AuroBlog - Aurous Healthcare Clinical Trials blog

JANUARY 9, 2024

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.

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Research Clinical Trials Clinical Trials Clinical Research 219

Rethinking Clinical Trials

JANUARY 9, 2024

          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

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Trials Clinical Trials Clinical Trials Research 275

Bio Pharma Dive

JANUARY 9, 2024

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

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Pharmaceutical Technology

JANUARY 10, 2024

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

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Gene Editing Gene 244

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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.

Clinical Trials

AuroBlog - Aurous Healthcare Clinical Trials blog

JANUARY 8, 2024

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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Clinical Trials Clinical Trials Clinical Research Trials 198

Rethinking Clinical Trials

JANUARY 10, 2024

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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Clinical Trials Clinical Trials Clinical Research Medicine 183

Bio Pharma Dive

JANUARY 8, 2024

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.

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Sales 305

Pharmaceutical Technology

JANUARY 7, 2024

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

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Drugs 246

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.

Clinical Research

AuroBlog - Aurous Healthcare Clinical Trials blog

JANUARY 7, 2024

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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Regulation Clinical Trials Clinical Trials Clinical Research 188

Rethinking Clinical Trials

JANUARY 9, 2024

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

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Trials Clinical Trials Clinical Trials 141

Bio Pharma Dive

JANUARY 10, 2024

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.

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Drugs 288

Pharmaceutical Technology

JANUARY 8, 2024

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

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Vaccination Vaccine Trials 246

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Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud

Clinical Research

AuroBlog - Aurous Healthcare Clinical Trials blog

JANUARY 11, 2024

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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Bacterium Bacteria Drugs Research 178

Pharma Mirror

JANUARY 11, 2024

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

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Drugs 130

Bio Pharma Dive

JANUARY 8, 2024

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

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Drugs 270

Pharmaceutical Technology

JANUARY 8, 2024

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

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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.

Clinical Trials

AuroBlog - Aurous Healthcare Clinical Trials blog

JANUARY 10, 2024

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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Clinical Trials Clinical Trials Clinical Research Trials 197

pharmaphorum

JANUARY 8, 2024

Dr Peter Marks, director of the FDA Center for Biologics Evaluation and Research told a packed house in San Francisco for JPM that FDA wants to support gene therapies in 2024.

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Gene Therapy Gene Research 131

Bio Pharma Dive

JANUARY 8, 2024

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

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Marketing 264

Pharmaceutical Technology

JANUARY 8, 2024

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

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Medicine Drugs 246

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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.

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