pharmaphorum
JANUARY 4, 2024
Amplifying the patient voice is essential for the success of clinical trials. Learn why it is crucial for patient engagement, recruitment, and overall trial success, and how it can address challenges such as transportation and financial barriers.
ACRP blog
JANUARY 3, 2024
Historically, patient recruitment and retention have been pressing issues within the clinical trial space. Eighty-five percent of trials fail to recruit enough patients, while 80% are delayed due to other factors like participant dropouts. These high rates are influenced by financial, emotional, and logistical barriers to participation, such as geographic location and travel-related costs, which prevent patients from enrolling in trials and accessing life-changing medicine.
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Bio Pharma Dive
JANUARY 2, 2024
A non-addictive pain pill faces its definitive test, while study results in ALS, a rare heart disease and lung cancer could have far-reaching implications.
Antidote
JANUARY 5, 2024
Though clinical trial patient recruitment is an integral part of the medical research process, it is often one of the most difficult aspects of conducting a study. There are various reasons for this challenge, and among them is the widespread existence of misconceptions about participating in research that many patients may see as a barrier to entry.
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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
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.
Antidote
JANUARY 29, 2024
For individuals living with a condition like melanoma, volunteering to participate in a clinical trial can be a rewarding experience. Not only will patients be able to gain access to potential new treatments, but they will also be directly contributing to research that can save lives — something that Jamie Troil Goldfarb has experienced firsthand. Jamie received a diagnosis of stage IV melanoma in 2011, only 11 weeks after giving birth to her child.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
JANUARY 3, 2024
A new report from Novotech delves into the multifaceted landscape of HIV, focusing on its impact, treatment, and global initiatives.
Bio Pharma Dive
JANUARY 30, 2024
Since a landmark paper in 2022, drugmakers have begun nearly a dozen trials of cell therapies for lupus, with more set to start. Here’s why their efforts are worth watching.
Fierce Pharma
JANUARY 19, 2024
A jury has found a former Pfizer statistician guilty of insider trading after a two-week trial in federal court in the Southern District of New York. | A federal jury has found a former Pfizer statistician guilty of insider trading after a two-week trial in Manhattan. The jury convicted Amit Dagar, 44, of Hillsborough, N.J., of using advance information on successful trial results for Pfizer’s COVID-19 treatment Paxlovid to make more than $270,000 in stock trades.
Rethinking Clinical Trials
JANUARY 3, 2024
In this Friday's PCT Grand Rounds, Rui Wang of Harvard Medical School will offer the final session in our special series, Advances in the Design and Analysis of Pragmatic Clinical Trials, with "Methods for Handling Missing Data in Cluster Randomized Trials." The session will be held on Friday, January 5, at 1:00 pm eastern. Wang is an associate professor of population medicine and the director of the Division of Biostatistics in the Department of Population Medicine at Harvard Medical School and
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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
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.
Drug Discovery World
JANUARY 19, 2024
The DDW Winter issue asks whether AI can deliver better immunotherapies for cancer and includes expert predictions on what to expect from the sector in 2024, alongside a supplement looking at SLAS2024 and an exclusive guide exploring therapeutic antibodies. DDW Winter 2023/2024 The post DDW Winter 2023/2024 appeared first on Drug Discovery World (DDW).
Pharmaceutical Technology
JANUARY 29, 2024
At the JP Morgan Healthcare conference, Merck (MSD) indicated its eagerness to continue to establish its place in the immunological space.
Bio Pharma Dive
JANUARY 4, 2024
Moonwalk Biosciences, the latest biotech cofounded by the gene editing scientist, joins other startups aiming to alter gene expression without changing DNA.
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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.
Fierce Pharma
JANUARY 2, 2024
On the heels of a major Paxlovid inventory write-off in the United States, many more doses of Pfizer's COVID-fighting antiviral are going to waste overseas. | At the end of November, more than 1.5 million courses of Pfizer’s Paxlovid had expired unused in European countries, analysts at Airfinity said in a new report. The total tally of expired doses in Europe is expected to hit 3.1 million by the end of next month, representing a value of $2.2 billion.
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.
pharmaphorum
JANUARY 9, 2024
Discover how the UK Biobank is leveraging technology and the power of genomics in data-driven disease research. Join the digital revolution in understanding and combating diseases using cutting-edge techniques and large-scale genomic data analysis.
Drug Discovery World
JANUARY 5, 2024
Kyverna Therapeutics has revealed plans to progress to Phase II trials of KYV-101 for multiple sclerosis (MS) following a green light from the US Food and Drug Administration (FDA). KYV-101 is an autologous, fully human CD19 chimeric antigen receptor (CAR) T-cell product candidate for use in B cell-driven autoimmune diseases. “This approval is a critically necessary step that paves the way to enrol patients with treatment-refractory progressive MS for whom there are no currently available
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.
Pharmaceutical Technology
JANUARY 29, 2024
The rapid sequencing of the SARS-CoV-2 and the subsequent development of mRNA vaccines led to the authorisation of the first of these vaccines in late 2020.
Bio Pharma Dive
JANUARY 17, 2024
The offering is the fifth outlined by a biotech startup this month, suggesting companies are becoming more willing to gauge investors’ appetite for new stock offerings.
Fierce Pharma
JANUARY 22, 2024
As many have feared, the FDA’s investigation into secondary T-cell cancers following treatment with existing CAR-T therapies is poised to lead to a classwide black box warning. | As many have feared, the FDA's investigation into secondary T-cell malignancies following treatment with existing CAR-T therapies is poised to lead to a classwide black box warning.
Antidote
JANUARY 26, 2024
Colorectal cancer (often shortened simply to colon cancer) is the fourth-most commonly diagnosed cancer in the United States, and it is estimated that around 150,000 Americans are diagnosed each year. While the average age of diagnosis is 66, young adults are getting diagnosed in higher numbers every year, and researchers are still unsure as to why.
Advertiser: FourKites
A research study conducted by The Journal of Commerce and FourKites surveyed hundreds of international shippers, exploring how their usage of global supply chain visibility technology has evolved since the onset of global disruptions caused by COVID-19. For international shippers, ocean freight visibility has evolved from optional to essential and satisfaction with visibility varies greatly depending on how it is obtained and delivered.
pharmaphorum
JANUARY 10, 2024
Novavax is a leading pharmaceutical company dedicated to creating protein-based vaccines for diseases like COVID-19 and malaria. Learn more about their innovative vaccine development process and their commitment to creating a healthier future.
XTalks
JANUARY 16, 2024
To date, the lack of objective longitudinal measures in central nervous system (CNS) clinical studies has resulted in less than 6 percent of drugs in this space making it to market. Many of the validated cognitive assessments today are paper based, introducing the potential for bias and limiting ethnic and geographic diversity in clinical studies. Additionally, blood biomarkers only provide a snapshot in time and do not provide insight into cognitive function.
Pharmaceutical Technology
JANUARY 5, 2024
AbbVie and Umoja Biopharma partnered for the development of in-situ CAR-T cell therapy candidates for oncology targets.
Bio Pharma Dive
JANUARY 29, 2024
The FDA is reviewing the companies’ application for a “tumor agnostic” indication for their drug Enhertu, which would break new ground for antibody-drug conjugates.
Speaker: Steve Goldstein, Sales Leader
Are you currently in sales, or involved in a business that depends on strong sales results? What about the extremely competitive world of medical device sales? What are some of the top challenges your customers face and how do you approach understanding what’s most important to them? Join Steve Goldstein, Sales Success Coach, Motivational Speaker and Medical Device Sales Leader from Gold Selling LLC., to discover critical strategies and approaches you can take to engage your customers, achieve g
Fierce Pharma
JANUARY 22, 2024
Even as Gilead looks to become an oncology powerhouse in the coming years, the company on Monday recorded a major setback for its antibody-drug conjugate (ADC) Trodelvy. | The antibody-drug conjugate did not significantly improve survival outcomes compared with a chemotherapy alone in previously treated patients with metastatic non-small cell lung cancer.
Antidote
JANUARY 25, 2024
Recruiting patients for clinical trials is a common challenge for study sponsors conducting research. For this reason, it is often a wise strategy to work with an agency that specializes in outreach. These agencies excel at helping sponsors achieve their research goals within defined timelines and budgets.
pharmaphorum
JANUARY 31, 2024
In this exclusive interview, Gene Kinney, CEO of Prothena, discusses the latest developments in the field of neurodegenerative diseases such as Alzheimer's and Parkinson's. Gain insights and advancements being made in the treatment of these conditions.
BioPharma Reporter
JANUARY 15, 2024
CellVoyant, an AI-first biotechnology spin-out from the University of Bristol accelerating the development of novel cell therapies, has announced a Â7.6 million seed round.
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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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