Top

Tag: Clinical Trials


Innovation, Research

FDA Further Harmonizing Clinical Research Regulations with HHS Common Rule

October 11, 2022

Via: Health IT Answers

Clinical trials play a crucial role in advancing science and supporting the development of new medical products to address unmet patient needs. Reliable data from well-designed trials about a medical product’s safety and effectiveness are critical to the U.S. Food […]


Innovation, Med Tech

FDA approves clinical trials of Abiomed’s Impella heart pumps

September 19, 2022

Via: Medical Device Network

The US Food and Drug Administration (FDA) has granted two approvals related to the clinical research of Abiomed’s Impella heart pumps. The regulator has approved the on-label RECOVER IV randomised controlled trial (RCT) of Impella heart pumps in acute myocardial […]


News

Power Launches with $7M to Diversify Clinical Trials

August 31, 2022

Via: HitConsultant

Eighty-six percent of U.S. clinical trials are delayed because of lack of enrollment, creating a massive bottleneck in disease research and drug development — and costing the life science system billions of dollars. Even more distressing: Less than 5 percent […]


Innovation, Research

H1 & Lokavant Partner to Power Next-Gen Clinical Trials

August 3, 2022

Via: HitConsultant

Lokavant is a clinical intelligence platform that improves the time, cost, and quality of trial planning and execution through data-driven analytics applications. Lokavant’s platform aggregates and integrates real-time data from disparate trial data sources, and powers advanced analytics enabled by […]


Innovation, Research

Global trial demonstrates some benefits of flu shots for heart failure patients

April 4, 2022

Via: ScienceDaily

People with heart failure who received an annual flu shot had lower rates of pneumonia and hospitalization on a year-round basis and a reduction in major cardiovascular events during peak flu season, in a study presented at the American College […]


Innovation, Research

Analysis offers new insights on the placebo effect and how to harness its therapeutic potential

February 22, 2022

Via: ScienceDaily

A network of brain regions activated by the placebo effect overlaps with several regions targeted by brain-stimulation therapy for depression, according to a new analysis by a team that included several researchers from Massachusetts General Hospital (MGH), who collaborated with […]


News

FDA approves Medtronic’s new TAVR system for aortic stenosis treatment

August 25, 2021

Via: medicaldevice-network.com

The US Food and Drug Administration (FDA) has approved Medtronic’s latest self-expanding transcatheter aortic valve replacement (TAVR) system for the treatment of symptomatic severe aortic stenosis. The Evolut FX TAVR system can offer easy usage as well as increased accuracy […]


Innovation, Research

Clinical trials during a pandemic – lessons from COVID-19

July 23, 2021

Via: The Medical News

A number of clinical pathologists from Cerba Laboratory recently presented some approaches on how to manage SARS CoV 2 variants during the clinical trial process. Dr. Benedicte Roquebert is based in the microbiology department of Cerba Laboratory and works on […]


Biomarker, Innovation

Finding Benefits in Cancer; Trial Slowdowns; Metastatic Breast Ca Surgery

December 30, 2020

Via: MedPageToday

A majority of patients with colorectal cancer found at least one benefit from their diagnosis. (Fox Chase Cancer Center) Half of disruptions in ongoing clinical trials resulted from slow patient enrollment. (GlobalData) Laboratory studies suggested that a drug used to […]


Innovation, Research

Coronavirus clinical trials are pausing over safety concerns – here’s what that means

October 15, 2020

Via: CNBC

Coronavirus clinical trials from drug giants Johnson & Johnson and Eli Lilly hit a snag this week after safety monitors halted them over bad reactions from participants. J&J said Monday it paused the late-stage trial of its coronavirus vaccine candidate […]


Innovation, Research

Two clinical trials use low-dose X-rays to treat COVID-19 pneumonia

June 17, 2020

Via: The Medical News

Previous studies have shown that low-dose, whole lung radiation in the form of X-rays can effectively treat severe pneumonia, with minimal side effects. Two clinical trials are applying a modern version of this concept to test patients who have acute […]


Wellness

Yoga keeps the mind and body young, 22 clinical trials show

June 4, 2019

Via: Medical News Today

Yoga refers to a series of mind-body practices that originate in Hindu tradition. However, they are growing in popularity across the world as an alternative well-being practice. Statistic show that in 2015 in the United States alone, as many as […]


Regulatory

FDA plans to fully tap real-world data and evidence

January 30, 2019

Via: Health Data Management

The Food and Drug Administration plans to exploit claims, clinical and patient-generated data—information not captured through traditional clinical trials—for post-marketing safety surveillance. “New streams of real-world data gathered from electronic health records, lab tests, wearable devices, insurance claims and even […]


News

Novartis’ $4 Million Gene Therapy — Real Price Or A Negotiation Ploy?

November 13, 2018

Via: Forbes

At its annual R&D investor day, Novartis updated the world on its drug pipeline and research priorities. It was an impressive session befitting a company that spends $9 billion annually on R&D (about 18% of its top line revenues). Novartis […]


Innovation, Research

Drug in clinical trials for Parkinson’s disease offers hope for treating heart failure

July 20, 2018

Via: The Medical News

A drug currently in clinical trials for treating symptoms of Parkinson’s disease may someday have value for treating heart failure, according to results of early animal studies by Johns Hopkins Medicine researchers. The drug, a member of a class of […]


News

Can we trust results from early clinical trials?

February 23, 2018

Via: Medical News Today

Results from early clinical trials investigating new treatments for chronic diseases may be drastically exaggerated, according to an analysis published this week. As the average human lifespan slowly expands, the number of people with chronic conditions is steadily rising. In […]


Regulatory

Foundation Medicine gets approval for cancer test in US

December 1, 2017

Via: medicaldevice-network.com

Molecular information firm Foundation Medicine has secured approval from the US Food and Drug Administration (FDA) for its comprehensive companion diagnostic test, FoundationOne CDx, for solid tumours. The genomic profiling (CGP) test is designed to identify people who could benefit […]


Innovation, Research

Popular Alzheimer’s drug shows promise in clinical trials for treating patients with sickle cell disease

November 7, 2017

Via: The Medical News

A popular drug commonly used to treat Alzheimer’s disease has shown promise in laboratory and clinical trials for treating patients with sickle cell disease (SCD). Researchers have found that the molecule memantine stabilizes the development, longevity and function of red […]


News

Actually, Many New Cancer Drugs May Be Helpful And Worth Trying

October 24, 2017

Via: Forbes

You might have heard that many new cancer medicines offer little benefit. This month, the BMJ published a review finding that for most cancer drugs approved by the European Medicines Agency between 2009 and 2013, there was neither published evidence […]


News

Clinical Trials Doctors Demand Ownership Of Patients’ Data

August 23, 2016

Via: Forbes

Earlier this month, a consortium of 282 clinical trials doctors, in an article in the New England Journal of Medicine, threw down the gauntlet against data sharing. Under the misleading title “Towards fairness in data sharing,” these scientists, who label […]