Sat.Feb 17, 2024 - Fri.Feb 23, 2024

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5 factors that drive up clinical trial recruitment costs

Antidote

While effectively recruiting patients is a necessary part of every study, it can also incur significant costs. Patient recruitment is one of the largest budget categories in a clinical trial , but often, this is due to ineffective outreach methods and expensive screen failures that contribute to excessive spending.

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Clinical research is about trial and error

pharmaphorum

Clinical research involves trial and error as part of the drug development process. Learn more about how to optimise drug trials and the important role of participants in clinical research.

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Improving Black Participation in Clinical Trials: Bridging the Gap

XTalks

Black participation in clinical trials, and the underrepresentation of minority groups in general in trials, remains low. This lack of diversity can lead to skewed results that may not accurately reflect the efficacy of medical interventions across all populations. It is therefore important to work towards increasing Black participation in clinical trials, which begins with understanding the barriers to participation and taking steps to address them.

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Opening Eyes and Doors to New Career and Learning Opportunities in Clinical Research

ACRP blog

When the ACRP Certified Professional (ACRP-CP®) certification launched in 2017, it made available to the clinical research field a rigorously developed and validated test leading to a credential highlighting the skills of professionals whose job roles do not easily stay within the boundaries of traditional clinical research coordinators (CRCs), clinical research associates (CRAs), or principal investigators.

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Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

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

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Why Proactive AME Studies are Critical to Accelerating Your Approval Journey

Worldwide Clinical Trials

During clinical development, new chemical entities (NCEs) require an absorption, metabolism, and excretion (AME) study. Also known as a human radiolabeled mass balanced study, the AME study aims to determine the overall metabolism and excretion pathways of the NCE, as well as to identify and quantify circulating metabolites relative to parent or total drug-related exposure.

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February 22, 2024: Updated Template Provides Guidance for Reporting of Pragmatic Trial Results

Rethinking Clinical Trials

An updated template from the NIH Pragmatic Trials Collaboratory provides guidance for the transparent reporting of the primary results of pragmatic clinical trials. The template includes elements from the Consolidated Standards of Reporting Trials (CONSORT) and its extensions. It also addresses secondary use of electronic health record data, involvement of research partners and healthcare systems in the conduct of pragmatic trials, and special ethical and regulatory considerations.

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Researcher’s Perspectives: How a personal connection created a career in clinical trials

Antidote

Behind every new treatment is the incredible team of doctors, researchers, patients, and clinical trial specialists who worked on the research that made it possible. Because every therapy must be rigorously tested through clinical trials before it can be approved, the process from creation to entering the market can be an arduous one — but it’s one that makes medical breakthroughs possible.

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IISc and BFI team up to maximise translational research projects

AuroBlog - Aurous Healthcare Clinical Trials blog

The Indian Institute of Science (IISc) and Blockchain For Impact (BFI) have teamed up to maximise translational research projects where the latter aims to allocate US$1 million. The collaboration, under the BFI-Biome Virtual Network Programme, will see BFI to support various research projects at the IISc.

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February 21, 2024: In This Week’s PCT Grand Rounds, Virtual Monitoring in Decentralized Clinical Trials

Rethinking Clinical Trials

In this Friday’s PCT Grand Rounds, Adrian Hernandez and Christopher Lindsell of Duke University will present “Virtual Vigilance: Monitoring of Decentralized Clinical Trials.” The Grand Rounds session will be held on Friday, February 23, 2024, at 1:00 pm eastern. Hernandez is the executive director of the Duke Clinical Research Institute (DCRI) and professor of medicine and vice dean in the Duke University School of Medicine.

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NEJM paper fills in details on ‘remarkable’ CAR-T result in autoimmune disease

Bio Pharma Dive

The full results spotlight cell therapy’s potential to treat lupus and other inflammatory conditions, but also the problems drug developers must solve first.

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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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Telehealth abortion is an “effective, safe” tool for equitable healthcare – US study

Pharmaceutical Technology

US patients are travelling to avoid abortion bans, but a new study has found telehealth prescriptions to be safe and effective.

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Long COVID Seems to Be a Brain Injury, Scientists Discover

AuroBlog - Aurous Healthcare Clinical Trials blog

Some form of brain injury could be behind the symptoms reported by those with long COVID, according to a new study, and adapting tests and treatments to match could aid progress in tackling the condition.

Scientist 201
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The opportunities and challenges facing rare disease therapies developers

pharmaphorum

Explore the opportunities and challenges facing rare disease therapies developers, including the impact of Rare Disease Day, FDA regulations, and cutting-edge technologies like CRISPR gene therapy.

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Iovance, with approval of ‘TIL’ cell therapy, readies for complex launch

Bio Pharma Dive

The biotech set a price of roughly $515,000 per patient for its therapy Amtagvi, the first to be approved based on a decades-old technique of using tumor-infiltrating lymphocytes.

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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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Immunocore and BMS partner to investigate first-line treatment for melanoma

Pharmaceutical Technology

The company will evaluate an IMC-F106C/Opdivo combination treatment in a Phase III registrational study called PRISM-MEL-301.

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CDSCO releases regulatory guidelines for sampling of drugs, cosmetics and medical devices

AuroBlog - Aurous Healthcare Clinical Trials blog

In its efforts to streamline and rationalise the sampling procedure and maintain a centralised monthly database the Central Drugs Standard Control Organisation (CDSCO) has released the final version of the regulatory guidelines for sampling of drugs, cosmetics and medical devices by drugs inspectors of the Central and State drug authorities.

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Travere's Filspari, J&J's Carvykti win support from CHMP in blitz of positive recommendations

Fierce Pharma

A narrow miss in a confirmatory trial has | Along with host of other positive recommendations, European drug regulators rendered a positive opinion on Travere's Filspari for full approval in Berger’s disease.

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Frontier gets $80M, Galapagos’ backing to make a better KRAS drug

Bio Pharma Dive

The startup’s Series C round will support a clinical-stage drug the company thinks could address some of the weaknesses of other KRAS-targeting medicines.

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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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FDA generic drug approvals rose in 2023 in bid for improved access

Pharmaceutical Technology

The FDA Office of Generic Drugs reported a rise in generic drug approvals, as several first-time generics entered the market.

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Scientists Reveal How Long a Cannabis High Actually Lasts

AuroBlog - Aurous Healthcare Clinical Trials blog

If you ask 50 different people how long the effects of cannabis last, you’re likely to get 50 different answers. This can be a problem for figuring out how long a patient using the drug for medical purposes is going to remain impaired. A meta-analysis of 80 papers published in 2021 narrowed down this timeframe.

Scientist 200
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To BioMarin CEO Alexander Hardy, hemophilia A gene therapy Roctavian needs 3 stars to align

Fierce Pharma

Even Alexander Hardy, the former Genentech leader who managed the blockbuster hemophilia drug Hemlibra, can’t immediately bend the laggard launch trajectory of BioMarin’s gene therapy Roctavian.

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BioMarin preaches patience amid slow sales for hemophilia gene therapy

Bio Pharma Dive

The company earned only $3.5 million last year from its Roctavian treatment, far below the $50 million to $150 million range it had forecast eight months ago.

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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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FDA accepts Regeneron’s BLA for linvoseltamab for review

Pharmaceutical Technology

The FDA has accepted Regeneron’s biologics licence application (BLA) for linvoseltamab to treat multiple myeloma for priority review.

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Would You Recognize a Seizure? Here’s How to Help as a Bystander.

AuroBlog - Aurous Healthcare Clinical Trials blog

Approximately 1 in 26 people develop epilepsy, a condition in which someone experiences recurring and unprovoked seizures. But experiencing a seizure does not always mean a person has epilepsy. Seizures can be provoked by acute head injuries, alcohol withdrawal and high blood sugar, among other things.

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Daiichi Sankyo plots €1B expansion to beef up antibody-drug conjugate production in Germany

Fierce Pharma

After laying out plans to absorb a pair of production subsidiaries in October, Japan’s Daiichi Sankyo is doubling down on its quest to dominate the red-hot antibody-drug conjugate (ADC) field. | Aiming to beef up development and manufacturing of antibody-drug conjugates, Daiichi Sankyo is plugging roughly €1 billion ($1.08 billion) into an expansion of its production facility in Pfaffenhofen an der Ilm, Germany.

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Behind the new kind of cell therapy that just won FDA approval

Bio Pharma Dive

One expert views Amtagvi’s approval as a catalyst for further investment in TIL therapies, akin to how Kymriah’s 2017 clearance buoyed CAR-T treatment.

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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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Xolair amplifies reach after FDA approval for treating food allergies 

Pharmaceutical Technology

Xolair is the first FDA-approved drug to reduce allergic reactions in people with one or more food allergies, as per Roche’s announcement.

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A Simple Blood Test Could Soon Predict Your Risk of Dementia

AuroBlog - Aurous Healthcare Clinical Trials blog

A detailed look at minute differences in the levels of specific proteins in blood has allowed researchers to identify potential early warning signs of dementia.

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Roche’s Xolair is first medicine for food allergy in US

pharmaphorum

Fast approaching the end of its patent life, Roche and Novartis’ Xolair is going out with a bang, picking up a new approval as the first and only drug therapy for people with food allergies in the US.

Allergies 126
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J&J secures EMA backing for earlier CAR-T use in multiple myeloma

Bio Pharma Dive

European drug regulators recommended clearing J&J and Legend Biotech's Carvykti for use as early as after first relapse, potentially giving the therapy an advantage over Bristol Myers’ Abecma.

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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.