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. One diagnostic example that I discussed in my presentation is autism.

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XTalks

SEPTEMBER 25, 2024

Patient-centricity isn’t a catchphrase in clinical trials—it’s a guiding principle for improving patient experiences. One of the most critical aspects of this is how patients are compensated for their participation in trials. Meghan Harrington VP, Clinical Trial Financial Management Medidata Alicia C.

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Clinical Trials Clinical Trials Trials Clinical Research 75

Pharma Mirror

JUNE 8, 2022

The post Novotech Sponsors Endpoints ASCO 2022 Expert Panel on Accelerating Oncology Clinical Trials in China appeared first on Pharma Mirror Magazine. According to the Endpoints ASCO session: “China and the US are the world’s largest oncology research destinations, and the.

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ACRP blog

OCTOBER 10, 2024

It’s even being used to review investigator invoices and automate financial reconciliations—a monthly headache every contract research organization, sponsor, and clinical trials operator will be more than happy to resign to machines. MGI puts the value of this contribution to clinical development at $15 billion to $25 b illion.

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Clinical Trials Clinical Trials Trials Life Science 69

XTalks

JANUARY 17, 2024

Estimates based on publicly available information suggest more than 40 percent of all new therapies in development are cancer treatments. Given this hotbed of activity, innovation in the space to drive faster decisions and more efficient trials is intense.

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Clinical Trials Clinical Trials Trials Gene Therapy 122

Outsourcing Pharma

JULY 2, 2024

Christine Guo, chief scientific officer at ActiGraph, discusses the pivotal role of wearable health technologies in revolutionizing sleep health measurement within clinical trials.

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Clinical Trials Clinical Trials Trials Clinical Development 93

XTalks

SEPTEMBER 12, 2024

Ryan Brown Regional Vice President Sales-Trial Landscape H1 Diversity in clinical trials is not just a regulatory box to check — it’s an ethical imperative and a scientific necessity. Incorporating SDOH data into trial planning ensures that studies are more inclusive and accessible to diverse populations.

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Clinical Trials Clinical Trials Trials Clinical Research 52

XTalks

AUGUST 22, 2023

Recruiting participants is perhaps the most challenging aspect of any clinical trial, regardless of the therapeutic area. Yet this one piece is also the most vital, with a trial’s ability to enroll and retain participants being a key predictor of a study’s future success. What is Clinical Trials For All?

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Clinical Trials Clinical Trials Trials Clinical Research 90

XTalks

MAY 28, 2024

The traditional clinical trials model is facing scrutiny. VivoSense , a pioneering company in the field of digital health technologies (DHTs) and digital endpoints for clinical trials, is aiming to enhance the efficiency and efficacy of clinical research. Integrating DHTs Across Drug Development Phases Dr.

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Pharmaceutical Technology

SEPTEMBER 23, 2022

In the trial, HU6 treatment also led to a substantial decline in liver, visceral and total body fat while preserving skeletal muscle mass. A Phase IIa trial was recently launched that enrolled obese subjects with HFpEF while a Phase IIb trial in obesity, including a subset of obese subjects with type 2 diabetes, is planned to begin next year.

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Clinical Development Development Life Science Trials 242

Outsourcing Pharma

MARCH 13, 2024

In the fast-evolving landscape of clinical trials, technological advancements play a vital role in streamlining processes, enhancing efficiency, and ultimately improving patient outcomes.

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Clinical Trials Clinical Trials Trials Clinical Development 96

Outsourcing Pharma

JANUARY 9, 2024

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. Medable Inc.

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Clinical Trials Clinical Trials Trials Clinical Development 105

Outsourcing Pharma

APRIL 29, 2024

OSP spoke to Berkeley Research Group healthcare managing director, Wendy Cheng for a discussion around developments in AI regulation for pharmaceuticals, clinical trials, and drug development at a global scale.

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Clinical Trials Clinical Trials Regulation Trials 93

XTalks

SEPTEMBER 16, 2024

Lung-MAP is a pioneering clinical trial designed to simultaneously test multiple treatments for non-small cell lung cancer (NSCLC) under a single, comprehensive “umbrella” protocol. Could you give us an overview of the Lung-MAP trial and its significance in the treatment of NSCLC?

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Clinical Trials Clinical Trials Trials Clinical Research 52

XTalks

JULY 29, 2024

Participant recruitment is challenging, especially in those indications in which there are competing clinical trials necessitating a comprehensive understanding of the disease research ‘landscape’ and targeted outreach and stakeholder collaboration.

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Clinical Trials Clinical Trials Trials Research 103

Outsourcing Pharma

JULY 2, 2024

Christine Guo, chief scientific officer at ActiGraph, discusses the pivotal role of wearable health technologies in revolutionizing sleep health measurement within clinical trials.

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Clinical Trials Clinical Trials Trials Clinical Development 78

Worldwide Clinical Trials

OCTOBER 31, 2023

Last year, we witnessed a significant milestone in oncology clinical development, with almost 50% of all development programs focused on oncology assets. To encourage further expansion and innovation in cancer studies, it’s critical to consider what contributes to success in an oncology trial.

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Trials Clinical Trials Clinical Trials Clinical Development 189

XTalks

AUGUST 19, 2024

The synergy between clinical trial quality and operations teams is vital for delivering value to sponsors. Clinical trial sponsors often face the challenge of managing complex projects with multiple stakeholders, each with their own priorities and workflows.

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Clinical Trials Clinical Trials Trials Life Science 64

Pharmaceutical Technology

APRIL 26, 2023

Biotechnology company Adcentrx Therapeutics has raised $38m in Series A+ financing to advance its pipeline of new antibody-drug conjugate (ADC) therapeutics into clinical development. ADRX-070 is the company’s lead candidate and is anticipated to enter a first-in-human Phase I clinical trial in the second half of 2023.

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Clinical Development Development Clinical Trials Clinical Trials 147

XTalks

AUGUST 16, 2024

The effectiveness of clinical trials often depends on the quality and depth of the data utilized. This rich data resource has significant potential to innovate clinical trials, providing real-world, timely insights that can enhance success and streamline trial processes.

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Clinical Trials Clinical Trials Trials Clinical Research 59

Outsourcing Pharma

OCTOBER 10, 2024

The FDA decision will enable Antag Therapeutics to initiate the clinical development of its lead candidate drug, a first-in-class treatment for obesity.

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Clinical Trials Clinical Trials Clinical Development Drugs 87

pharmaphorum

AUGUST 24, 2022

Diversity in clinical trials is a “scientific imperative”, but how can industry bridge the gap between “why” and “how”? Removing barriers to clinical trial participation for underserved groups is an essential part of addressing health inequalities. Clinical trial participation, she went on, was vital.

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Clinical Trials Clinical Trials Trials Development 109

XTalks

JUNE 4, 2024

In the ever-evolving landscape of pharmaceutical development, the complexity of early phase clinical trials is increasing. This surge in complexity is driven by escalating drug development costs, heightened competition and advanced scientific innovations. This is the storm that we find ourselves in the midst of.”

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Clinical Development Development Clinical Trials Clinical Trials 105

FDA Law Blog

NOVEMBER 10, 2024

Food and Drug Administration (FDA) plays a pivotal role in fostering the development of treatments for rare diseases through its Orphan Products Grants Program. Each year, FDA selects a limited number of clinical trials to fund to help sponsors pursue development of medical products for rare diseases and advance their field.

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Production Clinical Development Development Regulation 67

Worldwide Clinical Trials

DECEMBER 7, 2023

Amidst a shifting clinical landscape characterized by increasingly complex trial designs and growing patient subpopulations, many contract research organizations (CROs) have adopted a “one-stop-shop” strategic approach. Moreover, these delays impact getting potentially lifesaving therapies to patients in need.

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Clinical Development Clinical Trials Clinical Trials Trials 341

STAT News

OCTOBER 13, 2022

Relmada Therapeutics said Thursday that its experimental treatment for depression failed to achieve the primary goals of a large clinical trial, a significant setback for the company’s only medicine in clinical development.

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Clinical Trials Clinical Trials Trials Drugs 105

Clinical Trial Podcast

SEPTEMBER 26, 2022

To answer these two questions, regulatory authorities around the world require medical product manufacturers to conduct Phase I, also known as early phase clinical trials. Dr. Cohen has more than 30 years of healthcare experience which includes his work on clinical development. Cohen to the Clinical Trial Podcast.

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Clinical Trials Clinical Trials Trials Clinical Research 98

Outsourcing Pharma

MAY 22, 2024

With Clinical Trials Day earlier in the week (May 20) OSP spoke to patient-focused companies to see what was happening in the clinical trials arena.

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Clinical Trials Clinical Trials Trials Clinical Development 52

Outsourcing Pharma

JULY 27, 2023

The EMA organized a task force made up of various stakeholders to gather insights on potential EU-level actions to improve the set up of clinical trials during public health emergencies.

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Clinical Trials Clinical Trials Trials Clinical Development 89

XTalks

JULY 9, 2024

In the dynamic landscape of clinical trials, ensuring compliance and maintaining high-quality standards are paramount. The field of quality and compliance in clinical trials is undergoing significant transformations driven by technological advancements, regulatory changes and evolving industry practices.

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Compliance Clinical Trials Clinical Trials Trials 59

pharmaphorum

NOVEMBER 11, 2022

The lack of diversity in clinical trials has been a topic of debate for decades, but was thrust into the spotlight as the impact of the pandemic on poorer, less educated and ethnically diverse populations became even more apparent. Both groups were poorly represented however in oncology trials. for Hispanics.

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Clinical Trials Clinical Trials Trials Pharma Companies 92

Outsourcing Pharma

MARCH 1, 2024

In the dynamic realm of clinical trials, where innovation and patient care intersect, Advarra believes it stands as a beacon of progress, continually revolutionizing how medical research is conducted.

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Clinical Trials Clinical Trials Trials Research 74

VirTrial

JUNE 17, 2024

Over the past decades, Myasthenia Gravis (MG) clinical trials have made remarkable progress in shining a light on this debilitating disease. Clinical trials in MG – What does history tell us? With a better understanding of the disease mechanisms, new target treatment options emerged in the 20th century.

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Clinical Trials Clinical Trials Trials Antibody 52

VirTrial

JUNE 17, 2024

Over the past decades, Myasthenia Gravis (MG) clinical trials have made remarkable progress in shining a light on this debilitating disease. Clinical trials in MG – What does history tell us? With a better understanding of the disease mechanisms, new target treatment options emerged in the 20th century.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Antibody 52

VirTrial

JUNE 17, 2024

Over the past decades, Myasthenia Gravis (MG) clinical trials have made remarkable progress in shining a light on this debilitating disease. Clinical trials in MG – What does history tell us? With a better understanding of the disease mechanisms, new target treatment options emerged in the 20th century.

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Clinical Trials Clinical Trials Trials Antibody 52

Outsourcing Pharma

OCTOBER 20, 2023

Feedback has been submitted to the US Food and Drug Administration (FDA) with guidelines intended for sponsors of clinical trials related to psychedelic compounds.

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Clinical Trials Clinical Trials Trials Drugs 100

pharmaphorum

JANUARY 14, 2022

In the latest episode of the pharmaphorum podcast, Dr Paul Tunnah speaks to head of Patient Engagement at Syneos Health, Marie Emms, and Elligo executive vice president and general manager of Worldwide Clinical Trials Early Phase Services, Keith Fern. Keith Fern joins Elligo with a decade of proven leadership in the CRO industry.

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Clinical Trials Clinical Trials Trials Compliance 97