Rethinking Clinical Trials

AUGUST 28, 2023

Food and Drug Administration (FDA) Slides Keywords Pragmatic trials; Research; Guidance, Regulatory, Data Governance Key Points The clinical trial enterprise needs modernization. Time, cost and failure to recruit trial participants are significant barriers that must be addressed.

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Rethinking Clinical Trials

FEBRUARY 28, 2024

            Speakers Adrian Hernandez, MD Executive Director, Duke Clinical Research Institute Vice Dean, Duke University School of Medicine Christopher J. The global decentralized clinical trial market is expected to grow at a compound annual growth rate of 30.1% from 2021 to 2026. I think we must.

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Rethinking Clinical Trials

FEBRUARY 20, 2024

             Speaker Jeffrey Carson, MD, MACP Principal Investigator and Study Chair MINT Trial Provost-New Brunswick, Rutgers Biomedical Health Sciences Distinguished Professor of Medicine Richard C. Trials in other clinical settings suggest the use of restrictive transfusion strategy, which is a lower hemoglobin level, is safe.

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Rethinking Clinical Trials

MAY 19, 2023

Colwill Professor and Vice Chair Department of Family and Community Medicine University of Missouri Slides Keywords Electronic Health Record, Pragmatic Clinical Trial Key Points Patients bring patient-generated home blood pressure data into the clinical workflow. Koopman, MD, MS) appeared first on Rethinking Clinical Trials.

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Rethinking Clinical Trials

JANUARY 17, 2024

UPMC did not allow patients to receive experimental COVID-19 therapies outside of the context of a clinical trial and used the REMAP-CAP platform, a global pragmatic adaptive trial platform, in all clinic sites. Setting clear inclusion/exclusion criteria based on highest level clinical evidence is crucial.

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Rethinking Clinical Trials

OCTOBER 2, 2023

The PROTEUS Consortium’s objective is to ensure that patients, clinicians, and other decision-makers have high-quality PRO data from clinical trials and clinical practice to make the best decisions they can about treatment options. It collates and synthesizes foundational resources to create a unified, comprehensive resource.

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Rethinking Clinical Trials

FEBRUARY 14, 2024

It had a pragmatic recruitment model with an embedded design, multicenter study without local study investigators and management teams, and broad recruitment that included patients from all 50 states and Puerto Rico. Both drugs have a well-established safety profile and would be a good fit for a pragmatic design.

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Rethinking Clinical Trials

FEBRUARY 13, 2023

The NITRIC Trial was a double blind, multicenter, randomized, parallel-group trial recruiting at 6 pediatric cardiac surgical centers in Australia, New Zealand, and The Netherlands. The design of platform trials can build on the lessons learned from this study. COVID-19 absorbed everyone in the middle of the trial.

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Pharmaceutical Technology

JANUARY 17, 2023

On January 12, Versanis Bio announced that enrollment had begun for its Phase IIb trial, BELIEVE (NCT05616013), which aims to study bimagrumab’s (BYM-338) efficacy and safety in the US, among other locations. In addition to facilitating loss of fat, the Phase II trial also showed that a lean mass gain of 4.5% was observed in the study.

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Rethinking Clinical Trials

JANUARY 26, 2023

EVOLVE-MI is a pragmatic, effectiveness outcome trial of Evolocumab dosed within 10 days of a myocardial infarction (MI). Participants within 10 days of index MI will either receive Evolocumab (140mg Q2W) every two weeks plus routine clinical care or standard of care. EVOLVE-MI is enrolling 4,000 patients in 3 countries.

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pharmaphorum

DECEMBER 24, 2021

Biogen and Eisai head towards the end of the year with some much-needed good news in their Alzheimer’s programmes, as the FDA awards a fast-track designation to lecanemab, their follow-up to recently approved Aduhelm.

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Rethinking Clinical Trials

MAY 25, 2023

A pilot study, called the ADAPT trial, demonstrated feasibility, similar in-patient compliance and similar post-discharge adherence for the 2 options. The pragmatic randomized control trial was designed from a hospital policy perspective. This inspired the research team to shift the primary outcome to death.

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Rethinking Clinical Trials

JANUARY 31, 2024

The second key decision point is development and adaptation, which is either building or adapting an external solution for internal clinical use. The next key decision point is clinical integration. For the CKD example, we combined data from Duke and claims data.

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Rethinking Clinical Trials

FEBRUARY 9, 2023

The study team’s health informatics group developed a novel clinical decision support (CDS) tool, called IMPROVE-DD VTE CDS, which can be integrated into different electronic health record (EHR) systems. It was important to observe behaviors in real time and be open to making changes at multiple points during the design and testing process.

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Rethinking Clinical Trials

MARCH 1, 2023

One network is the lead, but the trial will be available in all four U.S. We are working on inclusion and making sure all of our trials have buy in across the group. They are both approved and used widely in lung cancer, and combining two existing agents is logistically and clinically simpler.

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Rethinking Clinical Trials

AUGUST 30, 2023

To try to bridge the gap between PRO collection and meaningful use during clinical encounters, the RA PRO dashboard was developed. The RA PRO dashboard was tested as part of a stepped wedge, cluster randomized trial at the clinician level. 552 unique patient participated in the trial.

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Rethinking Clinical Trials

MARCH 28, 2023

It is an independent, nonprofit, research institute and leading funder of patient-centered comparative clinical effectiveness research (CER). It has grown to be a major force for supporting pragmatic research, both real-world evidence research and supporting observational research and pragmatic clinical trials.

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XTalks

JUNE 28, 2023

The approval is restricted to ambulatory patients within this narrow age range due to uncertainty around its effectiveness in older children, which Sarepta hopes to clarify in a confirmatory trial. Additionally, the FDA said a “clinical benefit of Elevidys, including improved motor function, has not been established.”

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Rethinking Clinical Trials

NOVEMBER 21, 2023

The idea was to engage the patient, providers, and healthcare system leaders to design, refine, and implement the pilot. Three healthcare delivery systems participated in the study: UC Health Clinics, Denver Health, and VA Eastern Colorado HCS Clinics. responded with a question for a clinical pharmacist.

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Rethinking Clinical Trials

OCTOBER 13, 2022

HandiCAP Trial, Pragmatic Clinical Trial. The HandiCAP trial asked the question do intraoperative handovers of anesthesia care have an impact on patient outcomes? The trial included adults 18 and older, ASA physical status III or IV, who had a major inpatient surgery with an anticipated duration of 2 hours or longer.

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Rethinking Clinical Trials

AUGUST 18, 2022

These terms and designations were intended to restrict rights. The Trial Innovation Network Recruitment Innovation Center aims to positively impact human health by improving participant enrollment and retention in multi-center clinical trials. Study design and approach should support diversity goals.

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Rethinking Clinical Trials

JUNE 7, 2023

The trial was designed to randomize 1,000 patients who had an On-X aortic valve replacement at least 3 months prior to randomization with either a standard dose of Apixaban (5mg) or continued warfarin (the standard of care). The trial took place at 64 sites, and randomized 863 patients. Learn more Read about the PROACT Xa study.

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XTalks

APRIL 18, 2024

Roche has received Breakthrough Device designation from the US Food and Drug Administration (FDA) for its Elecsys pTau217 early Alzheimer’s blood test. The Elecsys pTau217 assay is designed to detect amyloid pathology, a hallmark of Alzheimer’s disease, by measuring phosphorylated tau protein in human plasma.

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Rethinking Clinical Trials

NOVEMBER 21, 2022

Pragmatic Clinical Trials. In 2016, we published a pilot trial looking at high-flow nasal cannula (HFNC) therapy compared to CPAP in pediatric critical care. The step-up trial started recruitment in August 2019, 1,449 children were eligible, 600 children were randomized, and 595 consented. ? ? ? ? ? ? ? ? ? ?. Speakers.

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Rethinking Clinical Trials

OCTOBER 27, 2022

Duke Clinical Research Institute. Having a tech person on the study design team to advise on which devices are secure will allow as many people as possible to participate. Beyond privacy: A deeper understanding of the internet is required to protect digital trial participants. You need to involve them from the design phase.

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Rethinking Clinical Trials

JUNE 29, 2022

Real-world evidence (RWE) is clinical evidence derived from analysis of RWD regardless of study design. The post June 24, 2022: FDA Draft Guidance on Real-World Evidence (John Concato, MD, MS, MPH) appeared first on Rethinking Clinical Trials. and the FDA Draft Guidance for RWD/RWE. pctGR, @Collaboratory1.

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Rethinking Clinical Trials

AUGUST 10, 2023

“Serious games” are games designed for a purpose beyond pure entertainment. They use motivation, game design, competition, curiosity, collaboration, challenges, media, and learning to accomplish something. This can be useful in the context of clinical trials.

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pharmaphorum

APRIL 27, 2022

AstraZeneca and Daiichi Sankyo have claimed a fifth breakthrough designation from the FDA for Enhertu, shortly after showing the drug extended survival in patients with HER2-low metastatic breast cancer. Drugs given the designation are hastened through the development process by the FDA, which can grant them a faster six-month review.

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pharmaphorum

DECEMBER 23, 2021

Daiichi Sankyo has been granted breakthrough status by the FDA for patritumab deruxtecan, a HER3-targeted antibody-drug conjugate (ADC) in clinical trials for lung cancer. The post FDA gives Daiichi Sankyo’s HER3 drug a breakthrough tag appeared first on.

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XTalks

AUGUST 23, 2021

This is not a debate on approval,” said Stacie Weninger, PhD, president of the F-Prime Biomedical Research Initiative, in a focused topic session on the impact of drug approval on future clinical trials held on Tuesday July 27. Now that [aducanumab] is approved, how will this affect clinical trials going forward?”.

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Rethinking Clinical Trials

AUGUST 3, 2023

Design stand-alone data visualizations because one thing that happens in a social media world is that the graphs and visualizations very quickly escape their containers. Tags #pctGR, @Collaboratory1 The post Grand Rounds July 28, 2023: How Can Researchers Fight Misinformation About Medicine? We need to find a way to tackle this.

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Drug Discovery World

JANUARY 30, 2024

Lentivirus strategies are one of the most widely used tools in biomedical research and clinical testing, says Stella Vnook, CEO, Likarda. “Dr Streamlining trial designs and regulatory pathways can help. Increased clinical data and evidence of cost-effectiveness can improve coverage.

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The Pharma Data

OCTOBER 9, 2021

Roche (SIX RO, ROG; OTCQX RHHBY) now posted that gantenerumab, ananti-amyloid beta antibody developed for subcutaneous administration, has been granted Improvement Rectifier Designation by theU.S. This designation for gantenerumab marks the 39th Improvement Rectifier Designation for Roche’s portfolio of pharmaceuticals.

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XTalks

FEBRUARY 27, 2024

Since the activity of TILs can be suppressed by tumor cells, TIL therapies are designed to bolster the number of TILs. Addressing the high price tag, Iovance’s commercial chief Jim Ziegler said, “Payers have expressed their appreciation for the value proposition for Amtagvi.” billion into this T-cell immunotherapy segment since 2013.

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XTalks

OCTOBER 12, 2022

Magnetic resonance imaging (MRI) has had a part in clinical trials for more than three decades now. However, the role of MRI in new drug clinical trials can involve diagnosis of lesions and determination of their severity, early identification of therapeutic responders to drug treatment and treatment monitoring and follow-up.

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pharmaphorum

AUGUST 21, 2022

In this product, bupropion is designed to increase levels of dextromethorphan in the blood and extend its half-life. Axsome’s drug was given a breakthrough designation from the FDA, reflecting the need for new treatment options in patients at increased risk of self harm or suicide, and was also given a priority review.

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XTalks

FEBRUARY 8, 2024

Along with the hefty price tag for screen time that may not be perceived to be a worthwhile investment, and despite favoring advertising at other major events like the Grammys, pharma tends to stay somewhat clear of all the Super Bowl hoopla.

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