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.

Clinical Research 226

Clinical Research Research Gene Therapy Drugs 226

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.

Clinical Research 130

Clinical Research Research Clinical Trials Clinical Trials 130

Worldwide Clinical Trials

AUGUST 23, 2023

Patients are the backbone of clinical trials, playing an essential role in the drug development process. This engagement is often less understood and is underutilized by sponsors, meaning a significant element of the trial and drug experience is missed during sponsor engagement with the FDA.

Trials 242

Trials Clinical Trials Clinical Trials Development 242

XTalks

NOVEMBER 19, 2024

In clinical research, diversity is more than a prerequisite for a successful drug — it’s a critical component that enhances the validity and applicability of clinical trial outcomes. Diversity Action Plans have now moved from being a “nice-to-have” to a “must-have” in clinical trial designs.

Clinical Trials 64

Clinical Trials Clinical Trials Trials Production 64

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.

Trials 189

Trials Clinical Trials Clinical Trials Clinical Development 189

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.

Clinical Development 116

Clinical Development Development Clinical Trials Clinical Trials 116

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.

Clinical Trials 69

Clinical Trials Clinical Trials Trials Life Science 69

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.

Clinical Research 111

Clinical Research Research Clinical Trials Clinical Trials 111

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.”

Clinical Development 110

Clinical Development Development Clinical Trials Clinical Trials 110

XTalks

DECEMBER 12, 2024

In clinical research, this includes designing trials that elevate the patient voice, reduce barriers to participation, and represent the diverse populations who will ultimately use these medical products. Access to information: Limited resources and educational materials hinder informed decision-making about trial participation.

Clinical Trials 59

Clinical Trials Clinical Trials Clinical Research Trials 59

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.

Immune Response 273

Immune Response Clinical Trials Clinical Trials Antibody 273

Outsourcing Pharma

DECEMBER 8, 2020

An expert from the clinical research technology specialist discusses how trial teams can use real-world evidence to improve study inclusivity.

Trials 119

Trials Clinical Research Research Clinical Development 119

Worldwide Clinical Trials

JUNE 13, 2024

The FDA Oncology Center of Excellence (OCE) is committed to further enhancing oncology research and as a result, has recently implemented several projects aimed to revolutionize oncology clinical trials. However, Project Optimus emphasizes the importance of dose-finding studies in early clinical development.

Trials 130

Trials Clinical Trials Clinical Trials Clinical Development 130

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.

Clinical Research 105

Clinical Research Research Trials Clinical Development 105

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.

Clinical Trials 116

Clinical Trials Clinical Trials Trials Life Science 116

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.

Clinical Trials 98

Clinical Trials Clinical Trials Trials Clinical Research 98

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.

Trials 111

Trials Clinical Trials Clinical Trials Clinical Research 111

Outsourcing Pharma

NOVEMBER 1, 2021

The cloud software firmâs Digital Clinical Trials Survey Report reveals that the industry is adapting to challenges caused by COVID-19 and other factors.

Clinical Research 102

Clinical Research Clinical Trials Clinical Trials Research 102

Outsourcing Pharma

FEBRUARY 15, 2022

An expert from the institutional review board services company advises what trends to look for in the clinical trial industry over the course of coming months.

Clinical Research 104

Clinical Research Clinical Trials Clinical Trials Research 104

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.

Trials 132

Trials Research Pharma Companies Clinical Trials 132

pharmaphorum

JANUARY 19, 2021

A survey by rare disease patient network Raremark found that 86% of the community members asked were interested in taking part in clinical trials. CEO Jeremy Edwards looks at how decentralised trial models can solve some of the challenges for clinical trial recruitment in rare disease.

Trials 133

Trials Research Clinical Trials Clinical Trials 133

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. The post Reimagining CRO Partnerships: The Emerging Preference for Midsize Organizations appeared first on Worldwide Clinical Trials.

Clinical Trials 130

Clinical Trials Clinical Trials Clinical Development Clinical Research 130

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.

Clinical Trials 98

Clinical Trials Clinical Trials Trials Clinical Research 98

pharmaphorum

DECEMBER 16, 2020

AbbVie is to begin clinical development of an antibody designed to neutralise the SARS-CoV-2 coronavirus after licensing the therapy in from Harbour BioMed and Utrecht University. AbbVie has begun a phase 1 clinical trial of the antibody, with clinical development beginning in the US and expanding into Europe.

Antibody 98

Antibody Trials Licensing Licensing 98

AuroBlog - Aurous Healthcare Clinical Trials blog

AUGUST 3, 2023

Researchers at the Indian Institute of Science (IISc) have found that picolinic acid, a natural compound produced by mammalian cells, can block several disease-causing viruses such as SARS-CoV-2 and influenza A viruses. The Institute is now looking for partners in pharma companies to pursue further clinical development of the findings.

Pharma Companies 189

Pharma Companies Research Clinical Development Development 189

Outsourcing Pharma

JANUARY 25, 2022

Am expert from the CRO discusses unique challenges associated with running clinical trials that stretch across national boarders and how to conquer them.

Clinical Research 97

Clinical Research Clinical Trials Clinical Trials Research 97

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. With a fresh take on a data-driven trial strategy, sponsors can create a new path for trials that also accounts for potential risks.

Trials 98

Trials Clinical Trials Clinical Trials Clinical Research 98

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. AI models can be used to monitor trial processes and automate tasks associated with data collection, review and analysis. Next generation of decentralised trials.

Clinical Trials 119

Clinical Trials Clinical Trials Trials Life Science 119

Outsourcing Pharma

DECEMBER 2, 2021

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

Clinical Research 64

Clinical Research Trials Research Clinical Development 64

Outsourcing Pharma

JULY 12, 2023

Ora, a clinical research organization (CRO) for ophthalmology pharmaceutical and device development, has partnered the North West London Clinical Trials Alliance, to improve the quality and access to clinical research in the region.

Clinical Trials 91

Clinical Trials Clinical Trials Trials Clinical Research 91

BioPharma Reporter

JANUARY 18, 2022

Regulatory bodies in the European Union have launched an initiative to develop the region as a focal point for clinical research and to better integrate clinical research in the European health system.

Clinical Trials 105

Clinical Trials Clinical Trials Clinical Research Trials 105

XTalks

MAY 20, 2021

Today is Clinical Trials Day 2021 — a day for recognizing the importance of clinical research in protecting and improving global health. Amid the alarmist headlines posted by other media outlets, Xtalks has remained balanced in its reporting of COVID-19 clinical trial results and safety data.

Clinical Trials 105

Clinical Trials Clinical Trials Trials Vaccine 105

pharmaphorum

FEBRUARY 11, 2021

Pharma companies face many challenges when involving patients in the design of clinical trials – but doing so can have huge benefits further down the line, improving the sustainability and quality of research.

Clinical Trials 101

Clinical Trials Clinical Trials Trials Clinical Research 101

XTalks

OCTOBER 29, 2024

Protocols drive every clinical study, guiding research teams from early inception through planning and into the trial’s execution. Clinical trial protocols are also very complex, with detailed schedules of assessments, inclusion/exclusion criteria and scientific reasoning all captured into a single written document.

Clinical Research 59

Clinical Research Research Clinical Trials Clinical Trials 59

XTalks

OCTOBER 23, 2024

Otsuka Pharmaceutical has announced positive interim results from its Phase III clinical trial for sibeprenlimab. The Phase III VISIONARY trial enrolled 530 adults aged 18 to 65, with varying degrees of kidney function, and most were at risk of progressing to end-stage kidney disease.

Trials 101

Trials Clinical Trials Clinical Trials Antibody 101

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.

Clinical Trials 105

Clinical Trials Clinical Trials Trials Research 105

ACRP blog

JUNE 13, 2024

Just in time to help recognize Pride Month , ACRP’s Clinical Researcher journal is pleased to share the first details from the lead peer-reviewed article on “Improving Cardiovascular Research for Transgender and Gender Diverse Populations” from a trio of WCG IRB expert contributors to the new issue going online today (June 13).

Clinical Research 59

Clinical Research Research Clinical Trials Clinical Trials 59