Drug Channels

SEPTEMBER 28, 2021

Curl up with your favorite pumpkin-spiced blog and savor these stories harvested from the Drug Channels patch: Fresh insights about hospitals’ specialty drug profits SSR Update: Drug prices keep dropping My $0.02 P.S. Please join the more than 12,500 consumers of my daily commentary and links to neat stuff at @DrugChannels on Twitter.

Hospitals 81

Hospitals Biosimilars Pharmacy Drugs 81

On Medicine

FEBRUARY 8, 2024

Why is the CHARMER trial important? In previous research by members of the CHARMER team, older people and their carers told us that they would like their medicines reviewed by doctors during their hospital stay. The CHARMER trial aims to i ncorporate proactive deprescribing as a routine aspect of care in Older People’s Medicine wards.

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Hospitals Trials Doctors Clinical Research 109

Conversations in Drug Development Trends

MARCH 1, 2024

These designs facilitate streamlined trial logistics and centralized governance and create higher-quality data. Master protocols allow a trial to perform multiple tests on diverse patient populations or diseases under a unified design. But how do they work, and when are they appropriate? What Are Master Protocols?

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Trials Disease Drug Development Clinical Trials 78

PPD

MAY 18, 2023

Yet, four out of five care partners of people with neurodegenerative disorders have never been informed of clinical trial opportunities , according to a survey of more than 250 caregivers conducted by PPD, the clinical research business of Thermo Fisher Scientific. There’s little time to lose.

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Clinical Trials Trials Clinical Research Doctors 86

Broad Institute

OCTOBER 23, 2023

This result was striking and it inspired us to build a resource to understand the drivers of this risk,” said Amit Khera, co-principal investigator of OurHealth, a cardiologist at Brigham and Women’s Hospital, and vice president of genomic medicine at Verve Therapeutics.

Disease 145

Disease Research Hospitals DNA 145

On Medicine

MAY 17, 2023

Yet, what about those who took part in the trial? In recent years there has been an increasing call to let trial participants know the results of trials in which they have taken part. Back in 1995 only one person in every 27 was on a trial in cancer. The post Clinical Trials Day 2023: what about the trial participant?

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Clinical Trials Trials Research Hospitals 52

FDA Law Blog: Drug Discovery

SEPTEMBER 28, 2023

Hear about the new requirements under FDORA related to increasing diversity in clinical trials, strategies for increasing the participation of subjects from historically underrepresented groups, and how these new requirements and approaches should be considered in clinical trial and other related agreements.

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Clinical Trials Trials Hospitals Drugs 52

Conversations in Drug Development Trends

OCTOBER 14, 2024

With the support of global networks like ours at Worldwide Clinical Trials (Worldwide), autoimmune and bone health research is accelerating, providing new solutions to patients around the world. One of the biggest hurdles in developing new therapies is recruiting diverse patients for clinical trials.

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Research Clinical Trials Therapies Immune Response 52

Conversations in Drug Development Trends

MARCH 20, 2024

One way to ensure customized disease management is to utilize pharmacogenomics (PGx) in your clinical trial. As the study of how an individual’s genes affect their response to drugs, pharmacogenomics is a critical factor in developing effective and safe drugs and dosages in clinical trials.

Clinical Trials 52

Clinical Trials Trials Treatment Compliance 52

Broad Institute

NOVEMBER 25, 2024

As a proof of concept, a drug designed to target a newly discovered biological node is showing efficacy in treating rare genetic diseases in the kidney, the eye, and the brain and is now making its way to clinical trials in collaboration with a pharmaceutical partner. You can learn more about how clinical trials work here.

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Clinical Trials Disease Trials Therapies 52

PPD

OCTOBER 17, 2024

There has also been an increase in government and regulatory support for CGT trials, in conjunction with an increase in investments for these products to get to market. Site selection presents barriers and opportunities As cell therapies expand in Asia-Pacific, areas with large hospitals are often the main hubs for innovation.

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Therapies Clinical Trials Clinical Research Trials 97

SCIENMAG: Medicine & Health

DECEMBER 11, 2023

Gladwin, MD, announced today that the school will receive a $29 million research award over four years from the National Institutes of Health to lead a multicenter trial that aims to improve health outcomes in people who inject opioid drugs and are hospitalized with infectious […]

Hospitals 88

Hospitals Drugs Trials Research 88

Broad Institute

AUGUST 19, 2024

Jude Children’s Research Hospital have discovered that oleic acid, one of the most abundant fatty acids in the body, restores a healthy balance of vaginal microbes in a laboratory model of BV. At the Ragon Institute, Kwon’s lab is working to move this research toward a human clinical trial. “We Paper cited Zhu M et al.

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Hospitals Treatment Medical Schools Science 121

Drug Target Review

DECEMBER 16, 2024

This field allowed me the privilege of tending to children in the hospital and building long-term relationships with them and their families. In addition to this, I also chaired national trials evaluating an anti-GD2 antibody in pediatric osteosarcoma.

Medical Schools 52

Medical Schools Clinical Research Drug Development Trials 52

Olympian Clinical Research

OCTOBER 14, 2021

If you’re thinking about joining a clinical trial, there are many benefits you could look forward to. But how can you tell if clinical trials are right for you? We’ve outlined five reasons why joining a clinical trial might be in your best interest. You’re Helping to Advance Medical Knowledge.

Clinical Trials 52

Clinical Trials Trials Doctors Therapies 52

Advarra

OCTOBER 1, 2024

Managing clinical trial budgets efficiently is necessary for the success and sustainability of clinical research sites. Effective budget management not only ensures trials are financially viable but also maximizes return on investment (ROI). the impact and value of the data produced).

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Clinical Trials Trials Compliance Laboratories 52

Advarra

MARCH 6, 2025

For more than 35 years, Advarra has been committed to protecting the rights and welfare of clinical trial participants while helping to improve healthcare outcomes, advancing medical knowledge, and bringing innovative, life-extending treatments to market that benefit millions of patients worldwide.

Clinical Research 52

Clinical Research Research Clinical Trials Bioethics 52

Advarra

JUNE 9, 2022

Optimizing clinical trial access for potential patients is a critical goal for researchers and sponsors. Decentralized clinical trials (DCTs) can meet that need, but they come with some challenges. Designing a DCT comes with certain challenges of course, particularly when proposing to utilize outside groups or locations for the trial.

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Clinical Trials Trials FDA Pharmaceutical Companies 52

Drug Target Review

NOVEMBER 17, 2023

Up until 2023 around 600 NK cell clinical trials have been reported and some 200 are clinically active and still recruiting patients. The vast majority (65/74; 88%) of those trials involved NK cells without CARs; while only 12 percent were CAR-NK studies. CAR-NK cell trials only commenced in 2017 and most are still recruiting patients.

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Therapies Clinical Trials Cell Biology Trials 118

The Pharma Data

MARCH 8, 2021

Phase 2a study enrolled 202 non-hospitalized adults who had signs or symptoms of COVID-19 within 7 days and confirmed active SARS-CoV-2 infection. Findings from the primary efficacy and safety endpoints and additional secondary objectives will be presented at an upcoming medical meeting. This press release features multimedia.

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Trials Virus RNA Research Laboratories 69

Advarra

FEBRUARY 4, 2025

At a busy research site, a clinical trial is ready to launch but its stuck in limbo over a single paragraph in the informed consent form (ICF). While the trial waits for approval, patients who are eager for a new treatment face delay. Language relating to the potential cost of participation. Age isnt the only factor to consider.

Clinical Trials 52

Clinical Trials Trials Compliance Therapies 52

The Pharma Data

JUNE 26, 2021

Sanofi and Translate Bio initiate Phase 1 clinical trial of mRNA influenza vaccine. The trial will evaluate the safety and immunogenicity of a monovalent flu vaccine candidate coding for the hemagglutinin protein of the A/H3N2 strain of the influenza virus. JUNE 22 , 2021. We look forward to sharing initial results by year-end. ”. “

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Clinical Trials Vaccine Trials Immune Response 52

Drug Target Review

NOVEMBER 1, 2023

The mission of the CCDD is to discover novel small-molecule therapeutics for the treatment of cancer and progress them to hypothesis testing phase 1 clinical trials. Both of the ICR’s research laboratory sites in Sutton and in Chelsea are in close proximity to the Royal Marsden Hospital sites.

Fragment Screening 96

Fragment Screening Biochemical Assays Small Molecule Biophysical Assays 96

The Pharma Data

APRIL 27, 2023

The trial met its primary endpoint and demonstrated clinically meaningful benefits across secondary endpoints 1. The APPOINT-PNH trial also showed clinically meaningful benefits for secondary endpoints 1. These data were presented at the 49th Annual Meeting of the European Society for Blood and Marrow Transplantation (EBMT).

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Trials Treatment Hospitals Therapies 40

On Medicine

SEPTEMBER 27, 2023

A new nursing assessment instrument The VALENF Instrument comprises only seven items for the assessment of nursing care upon the admission of a patient to the hospital. Thus, it reduces the bureaucratic time of nurses in adult hospitalization units and allows more time for the direct care of patients.

Nurses 101

Nurses Hospitals Clinical Trials Research 101

Drug Target Review

NOVEMBER 17, 2023

Up until 2023 around 600 NK cell clinical trials have been reported and some 200 are clinically active and still recruiting patients. The vast majority (65/74; 88%) of those trials involved NK cells without CARs; while only 12 percent were CAR-NK studies. CAR-NK cell trials only commenced in 2017 and most are still recruiting patients.

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Therapies Clinical Trials Immune Response Trials 103

Drug Target Review

JANUARY 12, 2024

RWD includes things that are captured in routine care, including diagnosis, the pills prescribed, and the length of hospital stay. Much of the time that is not the same as what is measured in a clinical trial for an outcome. Surrogate endpoints can mimic endpoints used in clinical trials.

Doctors 111

Doctors Clinical Trials Treatment Therapies 111

The Pharma Data

OCTOBER 25, 2021

First immunotherapy combination to demonstrate superior clinical outcomes over standard of care in a global, randomised trial in this setting. TOPAZ-1 is the first Phase III trial to show that adding an immunotherapy to standard chemotherapy delivers a meaningful overall survival benefit for cases in this setting.

Trials 52

Trials Treatment Hospitals International 52

Broad Institute

NOVEMBER 7, 2023

To more precisely define cellular drivers of RA, an international research consortium co-led by researchers from the Broad Institute of MIT and Harvard and Brigham and Women’s Hospital analyzed tissues from RA donors at the single-cell level, integrating multiple forms of analysis to stratify RA by six subtypes of inflammation.

Treatment 96

Treatment RNA Hospitals Disease 96

The Pharma Data

AUGUST 16, 2021

Novartis today announced positive results from two Phase III clinical trials assessing Beovu ® (brolucizumab) 6 mg versus aflibercept 2 mg in patients with diabetic macular edema (DME). Both trials demonstrated an overall well-tolerated safety profile. for Beovu vs. 1.7% for Beovu vs. 1.7%

Trials 52

Trials Clinical Trials Treatment Disease 52

The Pharma Data

JULY 8, 2021

The update includes an addition to the Indications and Usage section of the label (Section 1) to emphasize the disease stages studied in the clinical trials, as seen below ( italics to note updated language). Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trial(s).

Clinical Trials 52

Clinical Trials FDA Approval Trials FDA 52

Cytel

FEBRUARY 20, 2024

Negative binomial probability distribution can be used to model the number of times a particular outcome occurs during a clinical trial. Here, I explain this statistical methodology and its application in adaptive group sequential clinical trial designs.

Clinical Trials 59

Clinical Trials Hospitals Trials Therapies 59

SCIENMAG: Medicine & Health

JUNE 14, 2023

Three young patients with relapsed T-cell leukaemia have now been treated with base-edited T-cells, as part of a ‘bench-to-bedside’ collaboration between UCL and Great Ormond Street Hospital for Children (GOSH).

Therapies 58

Therapies Clinical Trials Hospitals Trials 58

Alta Sciences

JUNE 27, 2023

Cancer Treatments, Clinical Trials, and the Motivation to Innovate nbartlett Tue, 06/27/2023 - 20:58 Getting to the Heart of Science with Michelle Newby At the heart of science are stories—stories of courage, challenges, successes, lessons, and people. A: I went with the clinical trial. A: I wouldn’t be here without clinical trials.

Clinical Trials 40

Clinical Trials Treatment Trials Science 40

Broad Institute

OCTOBER 4, 2023

A new small-molecule drug candidate being tested in an early-stage clinical trial aims to improve patient responses to immunotherapy. AbbVie and Calico are currently testing the molecule and another related molecule , also developed by AbbVie and Calico, in phase 1 clinical trials. We were really impressed by that.”

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Small Molecule Clinical Trials Trials Engineering 128

Agency IQ

APRIL 12, 2024

Landscape analysis: A look at the regulation of decentralized trials and what’s coming soon In the past few years, regulators and researchers have shown increased interest in leveraging decentralized trial methods – especially following the pandemic.

Regulations 40

Regulations Trials Clinical Trials Science 40

Drug Target Review

MAY 18, 2023

Tedesco Distinguished Chair of Paediatric Haematology and Oncology, are collaborating as co-principal investigators on a new clinical trial, which has been awarded a $2.3 The trial represents an early-stage effort to determine the viability of this approach. million grant from the National Heart, Lung and Blood Institute.

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