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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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.

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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 110

Pharmaceutical Technology

DECEMBER 1, 2022

Rebyota’s safety and efficacy were analysed in the largest trial programme in the microbiome-based therapeutics field, including five trials enrolling over 1,000 subjects. The latest development is based on the findings from the clinical programme including the double-blind, randomised, placebo-controlled Phase III PUNCH CD3 trial.

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Worldwide Clinical Trials

JUNE 13, 2024

In the last few decades, oncology research has witnessed countless innovations and breakthroughs, significantly extending the lives of those affected by cancer and improving their quality of life. However, Project Optimus emphasizes the importance of dose-finding studies in early clinical development.

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Trials Clinical Trials Clinical Trials Clinical Development 130

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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Pharma Mirror

JUNE 8, 2022

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

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Clinical Trials Clinical Trials Trials Clinical Development 130

Pharmaceutical Technology

OCTOBER 14, 2022

It is currently being assessed in combination with Merck’s anti-PD-1 therapy, Keytruda, as an adjuvant treatment for high-risk melanoma patients in a Phase II clinical trial being conducted by Moderna. The company said that the data from the ongoing Phase II trial will be reported in the fourth quarter of this year.

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Pharmaceutical Technology

MAY 22, 2023

SinoMab BioScience intends to commence a Phase I clinical trial in China to evaluate SM17’s safety profile. The company dosed the first healthy participant in a Phase I clinical first-in-human (FIH) clinical trial in June 2022.

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Immune Response Clinical Trials Clinical Trials Antibody 273

Worldwide Clinical Trials

JULY 29, 2024

Clinical development programs must acknowledge the complexity and variability of obesity as a condition. Partnering with a CRO that emphasizes the complexity of the patient’s voice and harnesses the nuances of clinical trial design is crucial for executing successful clinical research.

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Clinical Research Research Clinical Trials Clinical Trials 130

Pharmaceutical Technology

APRIL 3, 2023

The agreement allows Ablaze to clinically develop and commercialise the drug in Greater China. It is based on RayzeBio’s specialisation in targeted radiotherapy (TRT) discovery and Ablaze’s know-how in therapeutic product clinical development, as well as on the radiopharmaceutical infrastructure in China.

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XTalks

DECEMBER 10, 2024

In the trial, platelet response, defined as achieving at least 50,000 platelets per microliter or doubling baseline counts, was seen in 65 percent of patients on rilzabrutinib, compared to 33 percent on placebo. Participants received either rilzabrutinib or placebo for 24 weeks, followed by an open-label extension.

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Worldwide Clinical Trials

MAY 14, 2024

By: Amy Raymond, Derek Ansel, Nathan Chadwick, & Juliane Mills When choosing a CRO for a rare disease study, what truly sets them apart is their methodology: the CRO’s mindset, their approach to each unique study, and their agility in navigating the inherent complexities of rare disease research. Engage stakeholders EARLY.

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Trials Clinical Trials Clinical Trials Research 204

Camargo

JULY 30, 2021

Barry Mangum talks the importance of pediatric research, its evolution over the years, and the obstacles and opportunities that the industry faces as it moves forward. How long have you been in pediatric clinical research, and how did you enter the field? So I’ve been working in that space about 43 years.

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Clinical Research Research Gene Therapy Drugs 226

pharmaphorum

MARCH 12, 2021

COVID-19 has transformed the way we think about patient participation in trial design – but there are still many barriers to overcome in improving engagement. Speakers at the NIHR’s recent virtual event for the pharma industry discussed best practices for bringing patient insights into research.

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Pharmaceutical Technology

OCTOBER 21, 2022

Hookipa Pharma and Roche have signed a strategic partnership and licence agreement for developing HB-700 and another undisclosed arenaviral immunotherapy. Under the deal, Hookipa will carry out research and initial clinical development through Phase Ib for HB-700 to treat KRAS-mutated cancers.

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XTalks

DECEMBER 10, 2024

The surge in MASH cases stresses the need for early diagnosis, timely intervention and precise, reliable methodologies in clinical trials to evaluate new therapies effectively. Read on to gain insights from Medpace experts about advancements in imaging, histology and innovative techniques for MASH clinical trials.

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Clinical Trials Clinical Trials Trials Clinical Research 105

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 124

Pharmaceutical Technology

NOVEMBER 30, 2022

The latest development is based on data obtained from an open-label clinical trial of Biktarvy. According to the trial findings, the treatment was demonstrated to be effective and well-tolerated through 24 weeks in adolescents who are virologically suppressed and children with HIV infection.

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Marketing FDA Approval Clinical Trials Clinical Trials 246

pharmaphorum

NOVEMBER 17, 2020

Pharmaceutical companies often struggle to actively involve patients in the design phase of clinical trials but doing so can have huge benefits for the sustainability and success of research. Improving the design of commercial research by listening to the patient voice.

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Clinical Trials Clinical Trials Trials Life Science 116

pharmaphorum

FEBRUARY 21, 2022

The clinical research industry has long struggled with participant diversity. One study found that only 5% of Black or Asian United Kingdom residents had ever participated in a clinical trial. A study of FDA-approved vaccine trials from 2011-2020 showed that 78% of participants were white, even though only 60% of the U.S.

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Clinical Research Research Clinical Trials Clinical Trials 111

Pharmaceutical Technology

JUNE 12, 2023

Six cannabinoids have recently completed or are undergoing Phase II trials. In 2022, Pfizer acquired the drug, with the promise of accelerating clinical development via new, differentiated, and best-in-class approaches, enhancing optimism for further drug development.

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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 97

pharmaphorum

MAY 27, 2021

Sheila Rocchio highlights four key areas life sciences must improve on as an industry to drive real change in how clinical trials are conducted. With the availability of all this rich data from specialty devices and labs, researchers can gain a variety of insights. Next generation of decentralised trials.

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Clinical Trials Clinical Trials Trials Life Science 119

Worldwide Clinical Trials

APRIL 15, 2024

As the clinical research landscape continually evolves, the choice of a Contract Research Organization (CRO) partner can significantly impact the success of drug development programs.

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Clinical Trials Clinical Trials Clinical Development Clinical Research 130

XTalks

DECEMBER 19, 2024

Despite advancements in neuroscience and psychiatry, clinical trials for mental health conditions such as major depressive disorder (MDD), schizophrenia, bipolar disorder and generalized anxiety disorder face unique challenges. One of the main challenges lies in defining and selecting appropriate trial populations.

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Clinical Trials Clinical Trials Trials Research 52

pharmaphorum

JUNE 27, 2022

Almost half (48%) of cancer clinical trials in the US have no Hispanic or Latin American subjects, and 42% have no black patients, according to a diversity analysis focusing on thousands of studies conducted in the past 15 years. Figure 1: Ethnic composition of cancer clinical trial cohorts in the USA.

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Trials Clinical Trials Clinical Trials Clinical Research 111

Pharmaceutical Technology

AUGUST 18, 2022

The latest approval is based on findings from the Phase III clinical trials, HGB-207 (Northstar-2) and HGB-212 (Northstar-3), and the long-term follow-up LTF-303 study. The open-label, single-arm, 24-month Phase III trials enrolled 41 subjects of the age four to 34 years with non-?0/?0 0 genotypes.

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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

ACRP blog

JULY 26, 2022

“Everything we do in clinical trials is based on statistical principles, and you have to be comfortable with” them to flourish as a clinical trial professional, says Joy Frestedt, PhD, RAC, FRAPS, CPI, FACRP, president and CEO of Frestedt Incorporated and Alimentix, the Minnesota Diet Research Center.

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Trials Clinical Trials Clinical Trials Clinical Development 105

Fierce Pharma

SEPTEMBER 12, 2024

But how do we bridge clinical development with real-world care? How do we ensure trial endpoints are synchronized with real-world measures, payer requirements, and clinical society guidelines?

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Worldwide Clinical Trials

NOVEMBER 21, 2023

As a provider of end-to-end clinical development solutions, we plan to leverage our expertise to refine drug-disease matches identified by Every Cure’s use of AI and data analysis. At Worldwide, we deliver full-service clinical development to support drug approval and commercialization.

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Clinical Trials Clinical Trials Clinical Development Drugs 195

pharmaphorum

DECEMBER 2, 2022

Enrolling for clinical trials has become more challenging in recent years, with trial competition, increasingly complex protocols, and precision medicine targeting more niche patient populations. This emphasises sponsors’ need for enrolment predictability. per protocol, respectively. Country expansion to support enrolment.

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Trials Clinical Trials Clinical Trials Clinical Research 98

XTalks

OCTOBER 4, 2024

The push to increase diversity in clinical trials has gained momentum, but true progress requires more than regulatory mandates. In this webinar, industry leaders and patient advocates discussed how authenticity and the patient voice can be leveraged to enhance diversity in clinical trials.

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Clinical Trials Clinical Trials Trials Clinical Research 98

Outsourcing Pharma

DECEMBER 2, 2021

An expert from the ]contract research organization discusses the impact virtual trials have had on the industry, and how that transformation is likely to continue.

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Clinical Research Research Trials Clinical Development 104

Pharmaceutical Technology

OCTOBER 25, 2022

Ast ellas Pharma has announced plans to make a strategic investment to back the development of Taysha Gene Therapies’ adeno-associated virus (AAV) development programmes for Rett syndrome and giant axonal neuropathy (GAN). Astellas will also receive specific rights linked to any possible change of Taysha’s control.

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Gene Therapy Gene Development Genetics 264

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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