Rethinking Clinical Trials

DECEMBER 3, 2024

In a new report from the NIH Pragmatic Trials Collaboratory, a team of bioethicists explores the ethical obligation to share aggregate results from pragmatic clinical trials with research participants. The article was published online ahead of print in Clinical Trials.

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Rethinking Clinical Trials

JANUARY 29, 2025

ARBOR-Telehealth, an NIH Collaboratory Trial, is evaluating the use of a telehealth physical therapy strategy for patients who present to primary care clinics with low back pain in rural communities. ” The Grand Rounds session will be held on Friday, January 31, 2025, at 1:00 pm eastern. Join the online meeting.

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Rethinking Clinical Trials

MARCH 4, 2025

Researchers with PRIM-ER, an NIH Collaboratory Trial, published 2 innovative statistical techniques for evaluating intervention effects in stepped-wedge, cluster randomized trials. The article was published online in Statistics in Medicine. The article was published online in Statistics in Medicine.

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Bio Pharma Dive

JANUARY 7, 2025

Denali’s medicine and a similar one from Calico Life Sciences and AbbVie were not much different than a placebo, bringing the tally of failed drugs in the innovative “Healey platform trial” to seven.

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Bio Pharma Dive

JULY 15, 2024

Updated results show the biotech's RAS inhibitor shrank pancreatic tumors in 20% to 25% of study participants, but with high rates of side effects like rash and nausea.

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Bio Pharma Dive

MAY 31, 2023

The biotech, best known for its success developing migraine medicines, will seek approval of a treatment that failed a Phase 3 trial but showed signs of a positive effect.

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Bio Pharma Dive

MARCH 3, 2022

As Aduhelm sputters on the market, Roche aims to prove its experimental medicine can work better. A large, multi-year trial is part of that bet.

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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.

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XTalks

JANUARY 16, 2025

BlueRock Therapeutics, a subsidiary of Bayer AG, is making waves in the treatment of Parkinsons disease by advancing its investigational cell therapy, bemdaneprocel, to a Phase III clinical trial. The clinical advancement follows a thorough review of Phase I trial data under the FDAs Regenerative Medicine Advanced Therapy (RMAT) designation.

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Pharmaceutical Technology

MAY 23, 2023

The US Food and Drug Administration (FDA) has granted approval for Blueprint Medicines’ Ayvakit (avapritinib) as the first and only treatment for indolent systemic mastocytosis (ISM) in adult patients. The regulatory approval was based on the data obtained from the placebo-controlled, double-blind PIONEER trial.

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Rethinking Clinical Trials

OCTOBER 25, 2023

In this Friday’s PCT Grand Rounds, Harlan Krumholz of Yale University will present “Digital, Decentralized and Democratized: Lessons From the Yale PaxLC Trial.” The PaxLC Trial is a decentralized study of Paxlovid in adult participants with long COVID. Join the online meeting.

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Drug Patent Watch

DECEMBER 9, 2024

This intersection is where pharmacognosy meets drug patents, creating a unique landscape that shapes the future of medicine. Let’s embark on a journey to uncover the secrets of nature’s medicine cabinet and the legal frameworks that protect these discoveries.

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Pharmaceutical Technology

NOVEMBER 21, 2023

The new scheme will launch in 2024 and aims to save the National Health Service (NHS) £14bn over five years.

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Bio Pharma Dive

OCTOBER 26, 2022

On the heels of a major approval for Enhertu, the pharma reported positive results for two experimental drugs in settings where rival medicines from Roche and Sanofi recently failed.

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Rethinking Clinical Trials

DECEMBER 11, 2024

Gbenga Ogedegbe In this Friday’s PCT Grand Rounds, Gbenga Ogedegbe of the NYU Grossman School of Medicine will present “Home Blood Pressure Telemonitoring and Nurse Case Management in Black and Hispanic Patients With Stroke: A Randomized Clinical Trial.” Join the online meeting.

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AuroBlog - Aurous Healthcare Clinical Trials blog

SEPTEMBER 30, 2024

Researchers see a greater need for new generation therapeutics to propel precision medicine. The development of innovative therapeutic approaches in healthcare encompass a variety of fields, including gene therapy, personalized medicine, immunotherapy, and advanced biologics.

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Rethinking Clinical Trials

APRIL 15, 2025

TAICHIKNEE is supported within the NIH Pragmatic Trials Collaboratory through a cooperative agreement from the National Center for Complementary and Integrative Medicine. The post April 15, 2024: TAICHIKNEE Randomizes First Cohort in Study to Improve Knee Osteoarthritis Pain appeared first on Rethinking Clinical Trials.

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Pharmaceutical Technology

OCTOBER 3, 2024

Eli Lilly has announced a $4.5bn investment to establish the Lilly Medicine Foundry for drug production and manufacturing medicines for clinical trials.

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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. Nicola Owen, PhD, MBBS, Medical Directorthey shared insights into the operational and medical strategies that support the design and conduct of MASH clinical trials.

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Bio Pharma Dive

MARCH 23, 2023

The two companies gained billions of dollars in market value after their antibody drug succeeded against a disease that’s been difficult to treat with biologic medicines.

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Pharmaceutical Technology

JULY 7, 2022

But scientists have struggled to find effective treatments for many of these diseases since the dawn of modern medicine. It is certainly a pivotal moment for the cell and gene industry, with the next decade of R&D and clinical trials expected to transform the future of medicine.

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Bio Pharma Dive

MARCH 7, 2024

Early results from a Phase 1 study suggest the drug, amycretin, could be as potent as injectable medicines already sold by Novo and rival Eli Lilly.

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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. percent platelet response in a study published in The New England Journal of Medicine.

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Bio Pharma Dive

SEPTEMBER 12, 2024

Spun out of research at Nationwide Children’s Hospital, Vironexis claims it will be the first company to start a study testing a cancer drug delivered via the adeno-associated viruses commonly used in genetic medicines.

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Worldwide Clinical Trials

JUNE 13, 2024

Pharmacogenomics (PGx), the study of how genes affect a person’s response to drugs, has brought significant changes to the clinical trial industry. This high compliance rate is crucial for the successful implementation of personalized medicine, as it ensures a larger and more diverse patient population can benefit from PGx insights.

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AuroBlog - Aurous Healthcare Clinical Trials blog

SEPTEMBER 17, 2024

Biology is opening up new frontiers in medicine. We are witnessing a revolution in healthcare, driven by advances in genetics, Omics, RNA and CRISPR gene-editing technology, to deliver precision and personalised medicine, said Kiran Mazumdar-Shaw, executive chairperson, Biocon and Biocon Biologics.

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AuroBlog - Aurous Healthcare Clinical Trials blog

JULY 18, 2024

Researchers analyzed the electronic health records of more than 18,000 US patients between May 2022 and September 2023 to compare outcomes among those receiving the two injected medicines, and published the […]

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Rethinking Clinical Trials

DECEMBER 18, 2024

This was a multisite, practice-based, comparative effectiveness randomized clinical trial conducted at six public hospitals and three academic medical centers in New York City. Sustainment can be an Achilles Heel for embedded trials, as programs that have been shown to be successful arent always covered by insurance.

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Rethinking Clinical Trials

OCTOBER 16, 2024

Alexander Fanaroff In this Friday’s PCT Grand Rounds, Alexander Fanaroff of the University of Pennsylvania will present “Rigorous Testing of Behavior Change Interventions: Lessons From the BE ACTIVE Randomized Clinical Trial.” Fanaroff is an assistant professor of medicine at the University of Pennsylvania.

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Bio Pharma Dive

NOVEMBER 29, 2022

At a medical conference, the companies detailed clinical trial results that could help support approval of their drug, lecanemab. However, some doctors aren’t yet convinced the medicine’s risks are worth its potential benefits.

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Rethinking Clinical Trials

AUGUST 29, 2024

A virtual, asynchronous learning program that offers open-access modules to anyone interested in learning about the complex art of pragmatic clinical trial design and implementation is now available. Every week, a new open-access module features essential resources and leading Canadian trialists discussing a key component of clinical trials.

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Bio Pharma Dive

JUNE 17, 2024

Elevate precision medicine: dose optimization and immune monitoring through advanced liquid biopsies.

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Rethinking Clinical Trials

JANUARY 6, 2025

Fritz is the principal investigator of BeatPain Utah , an NIH Collaboratory Trial, and is a distinguished professor of physical therapy and athletic training and the associate dean for research in the University of Utah’s College of Health. Registration is required for participation this live web conference, but there is no cost.

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Rethinking Clinical Trials

DECEMBER 13, 2023

In this Friday's PCT Grand Rounds, Roxana Mehran of the Icahn School of Medicine at Mount Sinai will present "Diversifying Clinical Trials: A Path Forward." Mehran is a professor of medicine and the director of interventional cardiovascular research and clinical trials at the Zena and Michael A. Join the online meeting.

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Bio Pharma Dive

NOVEMBER 14, 2024

The company is paying China-based biotech LaNova Medicines $588 million for the type of dual-pronged antibody drug that recently bested Keytruda in a clinical trial.

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Bio Pharma Dive

DECEMBER 4, 2023

The biotech said Phase 2 study results showed its experimental medicine for age-related macular degeneration was "non-inferior" to Regeneron's Eylea.

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Bio Pharma Dive

APRIL 28, 2022

Called tirzepatide, the drug significantly lowered weight loss in a large study, findings that add to growing evidence that a class of medicines originally meant for diabetes may effectively treat obesity.

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