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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SCIENMAG: Medicine & Health

SEPTEMBER 22, 2023

A clinical trial has launched to test whether early intensive immune modulation for hospitalized COVID-19 patients with relatively mild illness is beneficial.

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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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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.

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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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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.

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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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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.

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The Pharma Data

APRIL 8, 2021

The trial did not meet statistical significance on the primary endpoint, which was defined as a difference in the proportion of participants progressing to the first occurrence of non-invasive ventilation including high flow oxygen or invasive mechanical ventilation including extracorporeal membrane oxygenation (ECMO) or death by Day 28. .

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Broad Institute

NOVEMBER 21, 2024

In a study published in Nature Cancer , researchers at the Broad Institute of MIT and Harvard, Dana-Farber Cancer Institute, and Massachusetts General Hospital investigated the evolution of these tumors, many of which are known to be initiated by mutations in an enzyme known as IDH.

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The Pharma Data

AUGUST 30, 2021

In this clinical first for adults with heart failure with preserved ejection fraction, empagliflozin demonstrated an impressive 21 percent relative risk reduction in the composite primary endpoint of cardiovascular death or hospitalization for heart failure 1. EMPEROR-Preserved included 5,988 people with heart failure.

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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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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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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 […]

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H1 Blog

SEPTEMBER 26, 2023

Breaking Down Barriers to International Clinical Trials Global Disruptions, Health Equity & Data Sharing As the U.S. When time is of the essence, like in a global pandemic, how do you scale trials internationally for success? Additionally, clinical trials are no longer confined to one country or region.

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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.

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Codon

JANUARY 21, 2024

Human challenge trials were an indispensable part of the development of the malaria vaccine, R21/Matrix-M, endorsed by the World Health Organization last October. But for all of their benefits, human challenge trials have their drawbacks. Jake himself has participated in both Zika and Shigella challenge trials.

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The Pharma Data

JULY 29, 2021

The EUA now provides for the use of baricitinib for treatment of COVID-19 in hospitalized adults and pediatric patients two years of age or older requiring supplemental oxygen, non-invasive or invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO). percent (24/515) for baricitinib plus remdesivir versus 7.1 In the U.S.,

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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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Broad Institute

AUGUST 7, 2024

Core institute members have a major research presence at Broad, and remain full members of their home institution (MIT, Harvard University, or one of Harvard’s primary teaching hospitals). Some of her discoveries have already led to clinical trials. She also leads Broad’s rare disease initiative, Ladders to Cures.

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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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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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The Pharma Data

JUNE 2, 2022

Orencia was one of two immune modulators that improved survival for people hospitalized with COVID-19. Bristol Myers Squibb (NYSE: BMY) today announced topline results from the Phase 3 Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV-1) Immune Modulators clinical trial, sponsored by the National Institutes of Health (NIH).

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The Pharma Data

MAY 16, 2022

million symptomatic cases of the virus, as well as 690,000 hospitalizations and more than 110,000 deaths. The profound health and economic impact of the Pfizer-BioNTech vaccine during its first year of rollout in the US is described in detail in a new study in the peer-reviewed Journal of Medical Economics.

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Drug Target Review

AUGUST 28, 2024

Resolution has recently been granted clinical trial authorisation (CTA) approval from the Medicines and Healthcare products Regulatory Agency (MHRA) for our EMERALD Phase I/II study which will begin in Q3 2024.

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The Pharma Data

APRIL 3, 2021

The CoVIg-19 Plasma Alliance today announced that the Phase 3 Inpatient Treatment with Anti-Coronavirus Immunoglobulin (ITAC) clinical trial sponsored and funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), did not meet its endpoints. About the ITAC Trial.

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The Pharma Data

MARCH 16, 2022

The Independent Data Monitoring Committee recommended that the EMPA-KIDNEY trial be stopped early, following a formal interim assessment EMPA-KIDNEY is the largest and broadest dedicated SGLT2 inhibitor trial in chronic kidney disease to date Detailed results are expected to be presented later this year.

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The Pharma Data

JULY 8, 2021

When added to the EMPEROR-Reduced trial results, these findings demonstrate Jardiance’s efficacy in all forms of heart failure regardless of ejection fraction. Heart failure is a leading cause of hospitalization and is becoming increasingly prevalent in Western countries due to aging populations.

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The Pharma Data

JUNE 30, 2021

1 “The risk of hospitalization for heart failure is up to five times higher if you have type 2 diabetes. Comprised of eight clinical trials and two real-world evidence studies, EMPOWER reinforces the long-term commitment of the Alliance to improve outcomes for people living with cardio-renal-metabolic conditions.

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The Pharma Data

MARCH 11, 2021

This was measured by improved time to hospital discharge up to day 28 in patients with severe COVID-19 pneumonia receiving standard of care. No new safety signals were identified for Actemra/RoActemra in the REMDACTA trial. The full results of the trial will be submitted for publication in a peer-reviewed journal later this year.

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Broad Institute

JANUARY 30, 2024

For his medical residency, he moved to Massachusetts General Hospital, where he was enthralled with seeing patients, especially the ones with perplexing infections. But in April 2020, “suddenly, half the patients at the hospital had a brand new infection, so we were busier than ever by a long shot,” he recalled.

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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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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.

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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.

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The Pharma Data

SEPTEMBER 2, 2021

The Phase 3 RENOIR trial of RSVpreF is a global, randomized, double-blind, placebo-controlled study that expects to enroll approximately 30,000 participants 60 years and older. 65 years of age are hospitalized and 14,000 of them die each year due to RSV. NEW YORK–(BUSINESS WIRE)– Pfizer Inc. 2 In the U.S.,

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The Pharma Data

OCTOBER 28, 2021

Bayer will present new renal and cardiovascular (CV) analyses from the comprehensive finerenone (Kerendia®) clinical trial program, including the Phase III FIGARO-DKD and FIDELIO-DKD studies, and the prespecified pooled analysis FIDELITY at the American Society of Nephrology (ASN)’s Kidney Week 2021 from 4-7 November.

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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.

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