March, 2024

article thumbnail

Maximizing Patient Recruitment: Introducing Marketing Packages for Every Budget

My Local Study

In the ever-evolving landscape of clinical research, one of the most significant challenges research sites face is patient recruitment. Without an adequate pool of participants, even the most groundbreaking studies can falter. Recognizing this critical need, MyLocalStudy is proud to introduce our new recruitment packages designed to streamline and optimize patient recruitment efforts for clinical.

article thumbnail

March 7, 2024: New Report Sets Out Posttrial Responsibilities in Pragmatic Clinical Trials

Rethinking Clinical Trials

Dr. Stephanie Morain In a new report from the NIH Pragmatic Trials Collaboratory, a team of bioethicists and implementation scientists argue for a “presumptive default” that the results of pragmatic clinical trials should be incorporated into healthcare delivery processes. This responsibility arises from a key rationale for conducting pragmatic trials: that they can facilitate uptake of their results by relevant decision-makers.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

The unique clinical trial challenges faced by digital therapeutics

pharmaphorum

On today’s podcast, host Jonah Comstock is joined by Meri Beckwith, co-founder of Lindus Health, a next-gen CRO that includes digital therapeutics among its specialties. They talk a little bit about the often unseen difficulties of validating a digital therapeutic through a clinical trial.

article thumbnail

What’s next for AAV gene therapies in 2024?

Pharmaceutical Technology

Upcoming regulatory events for pipeline AAV gene therapies, with a focus on neuromuscular and blood disorders, are setting high expectations for the space in 2024.

article thumbnail

From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.

The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven

article thumbnail

Epigenetic Editing Explodes on the Heels of Gene Editing Success

BioSpace

Ubiquitous potential, possible safety advantages and the recent growth of cell and gene therapy are driving investment in a different type of genetic editing.

article thumbnail

Prioritizing women, promoting diversity and a patient-first approach - how does CTM do it?

Outsourcing Pharma

OSP senior editor, Liza Laws, took some time at SCOPE 2024 in Orlando earlier in the year to speak with two female-focused members of the Clinical Trials Media (CTM) team, Katherine Seay and Veronica Berk to find out how.

More Trending

article thumbnail

The digital divide: Balancing automation and human interaction regardless of the patient support program model

Bio Pharma Dive

Balancing automated patient support with human touch is key in healthcare. Hybrid models offer a pragmatic path forward, prioritizing patient-centricity.

264
264
article thumbnail

Building the patient experience into observational studies produces stronger real-world evidence

pharmaphorum

Incorporating the patient experience into observational studies can enhance the quality of real-world evidence gathered. Learn how patient-centred approaches can lead to stronger research outcomes.

Research 119
article thumbnail

Oncology emerges as dominant therapy area for CRISPR technology

Pharmaceutical Technology

In late 2023, the Medicines and Healthcare products Regulatory Agency approved Vertex’s Casgevy, which became the inaugural clustered regularly interspaced short palindromic repeats (CRISPR)-based drug for the haematological indications beta thalassemia and sickle cell disease (SCD).

Medicine 278
article thumbnail

There’s a Surprisingly Simple Way to Remove Microplastics From Your Drinking Water

AuroBlog - Aurous Healthcare Clinical Trials blog

Tiny fragments of microplastics are making their way deep inside our bodies in concerning quantities, significantly through our food and drink. Scientists have now found a simple and effective means of removing them from water.

Scientist 246
article thumbnail

Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

article thumbnail

March 28, 2024: Health Equity Core Provides Reference for Equitable Language in Pragmatic Trials

Rethinking Clinical Trials

Dr. Rosa Gonzalez-Guarda The NIH Pragmatic Trials Collaboratory’s Health Equity Core developed a written aid to offer guidance on inclusive language and terms to use when referring to specific people, groups, and communities. The Equitable Language Cheat Sheet is available on the Health Equity Core webpage and will be updated as terminology and guidance evolves.

Trials 219
article thumbnail

Considering Master Protocol Use in Your Trial: Evaluating Basket and Umbrella Trial Designs

Worldwide Clinical Trials

With cost and timelines being two of the most significant factors influencing a study’s progression aside from efficacy and safety, master protocols offer an attractive option for study design. These designs facilitate streamlined trial logistics and centralized governance and create higher-quality data. But how do they work, and when are they appropriate?

Trials 195
article thumbnail

Amylyx ALS drug fails crucial study, putting company’s future in doubt

Bio Pharma Dive

The results have led Amylyx to pause promotion of Relyvrio and potentially pull it from the market in the coming weeks, a major blow to the company and ALS patients.

Drugs 344
article thumbnail

Swedish researchers develop new AI computer model to detect lymphatic cancer

Pharma Times

In the study, the Lymphoma Artificial Reader System accurately detected 90% of lymphatic cancers

article thumbnail

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

article thumbnail

The growing uses of medicinal cannabis

Pharmaceutical Technology

Demand for medicinal cannabis is increasing globally to treat a range of illnesses and conditions.

Medicine 340
article thumbnail

Extreme Case of Man Who Had 217 COVID Vaccines Surprises Scientists

AuroBlog - Aurous Healthcare Clinical Trials blog

Two hundred and seventeen. That’s how many vaccines a man in Germany claims to have received for COVID-19 in just 29 months – and his body isn’t reacting the way some scientists thought it would.

Scientist 246
article thumbnail

March 13, 2024: In This Friday’s PCT Grand Rounds, a Pragmatic Trial of Antibiotic Choice on Renal Outcomes

Rethinking Clinical Trials

Dr. Edward Qian In this Friday's PCT Grand Rounds, Edward Qian of Vanderbilt University will present "The Effect of Antibiotic Choice on Renal Outcomes: The ACORN Trial." The Grand Rounds session will be held on Friday, March 15, 2024, at 1:00 pm eastern. The ACORN trial compared the effects of cefepime vs piperacillin-tazobactam on the incidence of acute kidney injury among acutely ill adults.

Trials 189
article thumbnail

Making Informed Decisions in Your Oncology Study: Understanding Biomarkers

Worldwide Clinical Trials

Every step in a successful oncology study requires critical and carefully thought-out decisions. Biomarkers provide a rapid way to inform many clinical oncology study development decisions, including study endpoints. What are they, how do they work, and how can they benefit your oncology study? What Are Biomarkers, and How Are They Used in Oncology?

article thumbnail

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.

article thumbnail

Madrigal wins FDA approval of first drug for MASH

Bio Pharma Dive

Rezdiffra’s clearance is a turning point in the fight against the liver disease. But its sales potential is unclear, and competition could emerge from popular weight loss drugs.

article thumbnail

Parkinson’s UK grants funding of up to nearly £450,000 to four new research projects

Pharma Times

The globally fast-growing progressive neurological condition affects around 153,000 people in the UK

Research 145
article thumbnail

Eli Lilly-backed Zephyr AI secures $111m for precision medicine tech

Pharmaceutical Technology

The funds will be used to expand Zephyr AI's headcount and enhance datasets.

Medicine 312
article thumbnail

Many Dementia Cases Could Actually Be a Hidden Form of Liver Disease

AuroBlog - Aurous Healthcare Clinical Trials blog

A recent study of US veterans found that 10% of those diagnosed with dementia actually had a liver condition called hepatic encephalopathy (HE) – a treatable condition. The liver can be damaged by several things, including alcohol, fatty deposits and hepatitis viruses.

article thumbnail

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.

article thumbnail

March 27, 2024: A Cluster Randomized Trial to Improve Kidney Transplant Access, in This Week’s PCT Grand Rounds

Rethinking Clinical Trials

Drs. Amit Garg and Stephanie Dixon In this Friday’s PCT Grand Rounds, Amit Garg and Stephanie Dixon of Western University’s Schulich School of Medicine and Dentistry will present “Effect of a Multicomponent Intervention to Improve Patient Access to Kidney Transplant and Living Kidney Donation: A Pragmatic, Cluster-Randomized Trial.” The Grand Rounds session will be held on Friday, March 27, 2024, at 1:00 pm eastern.

Trials 173
article thumbnail

BioNTech Hit with NIH Notice of Default over COVID-19 Vaccine Royalties

BioSpace

The National Institutes of Health claims BioNTech is in default regarding alleged royalty payments the agency contends it is owed in connection with the company’s COVID-19 vaccine Comirnaty.

article thumbnail

Biotech stock fundings headed for best quarter in 3 years, Jefferies says

Bio Pharma Dive

Publicly traded companies raised nearly $10 billion in follow-on stock offerings in January and February, a financing surge that’s driving a “sector recovery,” the investment bank said.

328
328
article thumbnail

With Pfizer struggling in 2023, CEO Bourla hit with 35% pay cut to $21.6M

Fierce Pharma

Pfizer knew 2023 was going to be a challenging year of transition. But even the drugmaker was surprised by the plummeting demand for its COVID-19 products, missing badly on its 2023 guidance. | After a difficult year for Pfizer, in which its share price fell by 44%, CEO Albert Bourla’s compensation fell by 35% from $33 million in 2022 to $21.6 million in 2023.

article thumbnail

2022 Research: The Rapid Rise of Ocean Freight Visibility

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.

article thumbnail

Akums introduces Hydroxyurea oral suspension for sickle cell disease

Pharmaceutical Technology

Akums Drugs and Pharmaceuticals has introduced Hydroxyurea oral suspension, a room temperature-stable drug for treating sickle cell disease.

Drugs 306
article thumbnail

NABL Kolkata spearheads cutting-edge awareness programme on calibration of medical devices

AuroBlog - Aurous Healthcare Clinical Trials blog

In order to set in pioneering progress in Eastern India’s laboratory standards, the National Accreditation Board for Testing and Calibration Laboratories (NABL) Kolkata office has orchestrated a ground-breaking virtual awareness program, revolutionizing perspectives on calibration within the Eastern India region’s laboratories.

article thumbnail

March 21, 2024: NINR Announces Funding Opportunity to Improve Health and Advance Equity in Rural Populations

Rethinking Clinical Trials

The National Institute of Nursing Research (NINR) published a funding opportunity for research to improve health outcomes and advance health equity in rural populations. Rural populations experience high rates of many causes of morbidity and disability, and high and increasing rates of premature death. Meaningful and sustained improvements in the health of rural populations require effective solutions to address the underlying causes.

Nurses 173
article thumbnail

Cannabinoids show promise in acute migraine clinical trial

pharmaphorum

Inhaled cannabinoids have been shown to perform better than placebo in providing pain relief for people suffering from acute migraine in a clinical trial

article thumbnail

An Innovative & Creative Problem Solver Approach to Selling in the Medical Device Space

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