Bio Pharma Dive

MAY 19, 2023

The biotech, best known for its vaccine research, said its clinical trial is the first to report results of a messenger RNA therapeutic designed for intracellular protein replacement.

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Worldwide Clinical Trials

MARCH 20, 2024

In the increasingly advancing world of medicine, personalized care is a key factor that can progress your drug development efforts. One way to ensure customized disease management is to utilize pharmacogenomics (PGx) in your clinical trial. Reduces Trial Failures Oftentimes, clinical trials may fail due to a lack of efficacy.

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Rethinking Clinical Trials

FEBRUARY 19, 2024

In this Friday’s PCT Grand Rounds, Adrian Hernandez and Christopher Lindsell of Duke University will present “Virtual Vigilance: Monitoring of Decentralized Clinical Trials.” He also serves as co-principal investigator of the NIH Pragmatic Trials Collaboratory Coordinating Center. Join the online meeting.

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Rethinking Clinical Trials

JANUARY 22, 2024

What happens to a pragmatic trial intervention after the study ends? The article was published online ahead of print this month in the Journal of General Internal Medicine. The case studies in the article are from the ABATE Infection, LIRE, PPACT, PROVEN, STOP-CRC, and TSOS trials. Learn more about the NIH Collaboratory Trials.

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Rethinking Clinical Trials

JUNE 29, 2023

Joshua Denny as he discusses improving health through the All of Us research program. The post Podcast June 12, 2023: All of Us Research Program: Improving Health Through Diverse Technology, Huge Cohorts, and Precision Medicine (Joshua Denny, MD, MS) appeared first on Rethinking Clinical Trials. Read the transcript.

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Rethinking Clinical Trials

MARCH 6, 2024

Schell Professor of Management and Applied Economics MIT Sloan School of Management Slides Keywords Food-as-Medicine, Randomized Clinical Trial, Diabetes Key Points Diabetes is common and costly. Food-as-Medicine observational studies have had a large correlation with improved health. 9% of the U.S.

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Worldwide Clinical Trials

FEBRUARY 28, 2023

Rob found out that in 1980, a researcher in Birmingham, England first synthesized a very niche cancer drug in a small lab. Over the next few decades, that drug made its way through clinical trials, securing approval in 2007—just 36 months before Rob was diagnosed in 2010. But what was truly remarkable? But what was truly remarkable?

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Rethinking Clinical Trials

OCTOBER 22, 2023

What Are Pragmatic Clinical Trials? Description In this video, Dr. Lesley Curtis describes pragmatic clinical trials. Speaker Lesley Curtis, PhD Professor of Population Health Sciences and Medicine, Duke University Duke Clinical Research Institute Collaboratory Steering Committee Chair Related Why Should I Do A Pragmatic Trial?

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Drug Discovery World

JUNE 29, 2023

Cancer Research UK has joined the PRIME-ROSE project, a Europe-wide effort to boost patient access to precision cancer medicine (PCM). The DETERMINE trial The DETERMINE trial is a PCM platform trial open to adult, young adult and paediatric patients with any rare cancer type.

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Pharmaceutical Technology

FEBRUARY 27, 2023

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the refusal of the marketing authorisation for Me rck and Ridgeback Biotherapeutics’ Lagevrio (molnupiravir).

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Pharmaceutical Technology

JUNE 20, 2023

The Department of Health Abu Dhabi (DoH) has signed a memorandum of understanding with integrated healthcare company M42 and AbbVie Biopharmaceuticals to advance personalised medicine and genomics in the city. M42 was created through the combination of Mubadala Health and G42 Healthcare.

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Rethinking Clinical Trials

MAY 3, 2023

Joshua Denny, All of Us Research Program (Photo: Vanderbilt University Medical Center) In this Friday’s PCT Grand Rounds, Joshua Denny of the All of Us Research Program at NIH, will present “ All of Us Research Program: Improving Health Through Diverse Technology, Huge Cohorts, and Precision Medicine.”

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Rethinking Clinical Trials

APRIL 24, 2024

Matthew Semler In this Friday's PCT Grand Rounds, Lauren Milner of the US Food and Drug Administration (FDA) and Jonathan Casey and Matthew Semler of Vanderbilt University will present "Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations – FDA Regulation Development and Research Landscape."

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Rethinking Clinical Trials

OCTOBER 22, 2023

Why Should I Do A Pragmatic Trial? Description Dr. Lesley Curtis discusses reasons to conduct pragmatic clinical trials. Speaker Lesley Curtis, PhD Professor of Population Health Sciences and Medicine, Duke University Duke Clinical Research Institute Collaboratory Steering Committee Chair Related What Are Pragmatic Clinical Trials?

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Rethinking Clinical Trials

JULY 6, 2023

Michele Balas and Dr. Eduard Vasilevskis The NIH Pragmatic Trials Collaboratory is excited to add 2 new Demonstration Projects to its portfolio of innovative pragmatic clinical trials embedded in healthcare systems.

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Rethinking Clinical Trials

AUGUST 3, 2023

Bergstrom, PhD Professor, Department of Biology University of Washington Slides Keywords Research, Misinformation, Media, Social Media Key Points Misinformation abounds in medicine and about medicine. As researchers, we are producers and consumers of the medical literature. It is important to avoid hype.

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Rethinking Clinical Trials

APRIL 19, 2023

In this Friday’s PCT Grand Rounds, Amit Garg of Western University’s Schulich School of Medicine & Dentistry will present “Personalised Cooler Dialysate for Patients Receiving Maintenance Haemodialysis (MyTEMP): A Pragmatic, Cluster-Randomised Trial.” Join the online meeting.

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Rethinking Clinical Trials

JUNE 28, 2023

In this Friday’s PCT Grand Rounds, Adrian Hernandez, Pamela Tenaerts, and Craig Lipset will present “Decentralized Trials – From Guidance to Reality & What’s Left.” Tenaerts is the chief scientific officer of Medable, a cloud computing platform for decentralized clinical trials. Join the online meeting.

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Rethinking Clinical Trials

MAY 31, 2023

John Alexander In this Friday’s PCT Grand Rounds, John Alexander of Duke University will present “PROACT Xa and the Wizard of Oz: Behind the Curtain of a Pragmatic Decentralized Clinical Trial.” ” The Grand Rounds session will be held on Friday, June 2, 2023, at 1:00 pm eastern. Join the online meeting.

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Pharmaceutical Technology

AUGUST 11, 2022

Gemini Therapeutics has signed a definitive agreement to merge with Disc Medicine in an all-stock deal to create a clinical-stage biopharmaceutical company. The merged company is expected to be named Disc Medicine, which will have corporate headquarters in Watertown, Massachusetts, US. To back the merger, Disc raised funds worth $53.5m

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Drug Discovery World

MAY 17, 2023

Leveraging historical trial databases has become commonplace in assessing the feasibility of trials in therapeutic areas with a large breadth of clinical development history. EHR data also has a key role to play in designing future clinical trials.

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Rethinking Clinical Trials

MAY 15, 2024

Mahaffey is the associate dean for clinical research in the Stanford University School of Medicine and the director of the Stanford Center for Clinical Research. The post May 15, 2024: This Week’s PCT Grand Rounds to Feature the CardioHealth Alliance appeared first on Rethinking Clinical Trials.

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Rethinking Clinical Trials

JANUARY 25, 2023

Matthew Semler of Vanderbilt University will present “The PREPARE II Trial: Embedding a Pragmatic Trial Into Clinical Care During an Emergency Procedure.” Russell is an assistant professor of medicine and co-director of the Program in Medical ICU Research at the University of Alabama at Birmingham.

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Rethinking Clinical Trials

OCTOBER 20, 2023

How Do You Design Trials That Are Fit for Purpose? Description Dr. Lesley Curtis discusses how to design trials that are fit for purpose. appeared first on Rethinking Clinical Trials.

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Rethinking Clinical Trials

MARCH 22, 2023

In this Friday’s PCT Grand Rounds, Erin Holve, Russell Rothman, Schuyler Jones, and Neha Pagidipati will present “From Observational Studies to Pragmatic Clinical Trials: (Almost) A Decade of Research in PCORnet®.” Holve is the chief research infrastructure officer for PCORI. Join the online meeting.

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Rethinking Clinical Trials

JULY 26, 2023

Professor Carl Bergstrom In this Friday’s PCT Grand Rounds, Professor Carl Bergstrom of the University of Washington will present “How Can Researchers Fight Misinformation About Medicine?” ” The Grand Rounds session will be held on Friday, July 28, 2023, at 1:00 pm eastern.

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Pharmaceutical Technology

NOVEMBER 21, 2022

RVAC Medicines has signed a master research partnership agreement with the Agency for Science, Technology and Research (A*STAR) for analysing and developing solutions to build messenger ribonucleic acid (mRNA) manufacturing and analytics expertise in Singapore.

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Rethinking Clinical Trials

APRIL 17, 2024

Joseph Ross In this Friday’s PCT Grand Rounds, Joseph Ross of Yale University will present “The Yale Open Data Access (YODA) Project: 10 Years of Clinical Trial Data Sharing.” The YODA Project promotes open science, research transparency, and the sharing of clinical research data to support healthcare research.

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Pharmaceutical Technology

FEBRUARY 6, 2023

Researchers at the Feinstein Institutes for Medical Research have discovered a new protein that can be a potential therapeutic target for lethal sepsis. Led by Feinstein Institutes researcher Haichao Wang, the new study focuses on detecting protein mediators that might contribute to uncontrolled immune responses to lethal infections.

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Rethinking Clinical Trials

JULY 31, 2023

Building a Study Team for a Pragmatic Clinical Trial Description NIH Collaboratory investigator Dr. Lesley Curtis shares tips for building effective study teams for pragmatic clinical trials.

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Antidote

OCTOBER 3, 2023

Clinical trials are an integral part of the medical industry, as they are required for any new treatment to be approved. Every medicine used today, whether prescription or over the counter, is a result of the rigorous research process that is a clinical trial — and for these trials to take place, volunteers are vital.

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Rethinking Clinical Trials

DECEMBER 20, 2023

Yet enrollment of ethnic minorities in NIH clinical trials and for trials studying approved devices and drugs remains low. There are several strategies that will help increase diversity in CVD trials. Increasing diversity in trial leadership is one of the most important strategies to increase diversity among RCT participants.

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Rethinking Clinical Trials

SEPTEMBER 8, 2023

In this Friday’s PCT Grand Rounds, Matthew Prekker of the University of Minnesota and Jonathan Casey of Vanderbilt University will present “The DEVICE Trial: An Embedded, Pragmatic Trial of Emergency Airway Management.” ” The Grand Rounds session will be held on Friday, September 8, 2023, at 1:00 pm eastern.

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Rethinking Clinical Trials

MAY 10, 2023

Denny, MD, MS CEO, All of Us Research Program Slides Keywords Precision Medicine, All of Us Research Program Key Points The mission of the All of Us Research Program is to accelerate health research and medical breakthroughs, enabling individualized prevention, treatment, and care for all of us. .;

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ACRP blog

MAY 6, 2024

Also sharing advice on breaking free of unproductive habits on Saturday was Suzanne Kincaid, CCRA, ACRP-PM, FACRP, Consultant and Owner of Responsibility Research, in her session on “The Intersection of Technology and People: Harnessing Technology to Increase Efficiency and Build Relationships.” On Day Two of ACRP 2024 in Anaheim, Calif.,

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Rethinking Clinical Trials

SEPTEMBER 13, 2023

The DEVICE trial hypothesized that the use of a video laryngoscope will increase the incidence of successful intubation on the first attempt. The trial operated under an IRB waiver of informed consent with a patient information sheet. Learn more Read more in the New England Journal of Medicine. in the direct laryngoscope group.

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Velocity Clinical Research

NOVEMBER 21, 2023

“Without clinical research, there would be little if any development of new medicines,” says Isabelle Schenkenberger, MD. I’m proud and excited to be a part of it.” Dr. Schenkenberger is especially proud of her clinical trial research work in heart health, noting most new drugs never make it to market.

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