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

JULY 19, 2023

The objective of COORDINATE-Diabetes trial was to improve the implementation and adoption of these therapies by testing the impact of a clinic-level, multifaceted intervention on the prescription of 3 key groups of evidence-based therapies. This was a cluster-randomized trial of 42 cardiology clinics across the U.S.,

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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%

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Rethinking Clinical Trials

JULY 27, 2022

It is a decentralized, fully remote trial, and data are largely patient reported. – Before anyone was enrolled, which arm did you think would enroll the fastest? There was a lot of outreach to sites and they embraced the remote trial. We did not see as much diversity in this decentralized trial.

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Rethinking Clinical Trials

JANUARY 19, 2023

Researchers seeking to enroll people living with dementia need a plan for assessing participants’ capacity to consent to research participation. Caregivers may also need to be enrolled and give their own consent as they may be more involved as the participant’s cognitive impairment worsens. it can be a barrier.

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Rethinking Clinical Trials

SEPTEMBER 30, 2022

Randomized controlled trial. This trial took place in South Carolina at a time when Medicare was thinking about how to improve outcomes and if expanding home nursing services could improve health outcomes. The primary evaluation question for the trial was what is the impact of NFP on health outcomes when delivered at scale?

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Rethinking Clinical Trials

NOVEMBER 16, 2022

Ethics, Data Sharing, Pragmatic Clinical Trials. When you apply these rules to pragmatic clinical trials (PCTs), there are ethical challenges because PCTs often use waivers or alterations of informed consent and are embedded into ongoing clinical care using extant data. Assistant Professor of Obstetrics & Gynecology. Key Points.

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Rethinking Clinical Trials

AUGUST 22, 2022

The COVID-OUT Trial is a remotely delivered, Phase 3, de-centralized clinical trial at 6 participating institutions to see if Ivermectin, Metformin or Fluvoxamine would prevent severe COVID-19. Initially, the randomization of the trial was 1:1 Metformin or Placebo. The primary outcome of the trial was negative.

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Rethinking Clinical Trials

DECEMBER 6, 2022

Pragmatic Clinical Trials, Heart Failure, Diabetes. The TARGET-HF-DM is a pragmatic multicenter randomized controlled trial held at 6 sites in the U.S. The trial enrolled 187 patients, with 35% women, 47% African American, 10% Hispanic, age 59 years. Enrollment halted before planned sample size of 200 due to COVID-19.

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Rethinking Clinical Trials

JULY 22, 2022

There were four ACTIV fast-track focus areas: vaccines, preclinical, clinical trial capacity, and therapeutics – clinical. Candidate agents were triaged based on concurrent clinical trials, completion of a multiple ascending dose study, and availability of preclinical data before being scored based on predefined criteria.

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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. Only about 40% of our patients are enrolled in My UPMC. Many patients did not answer the phone.

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Rethinking Clinical Trials

AUGUST 23, 2022

There is a national priority to increase diversity in clinical trials, from regulatory, funding agencies, industry, and others, so that the participant population reflects the U.S. The Duke Clinical Research Institute (DCRI) organized and sponsored a Think Tank to address diversity in clinical trial research. Learn more.

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Rethinking Clinical Trials

MAY 5, 2023

Assistant Professor of Medicine and Biomedical Informatics Medical Director, VICTR Center for Learning Healthcare Vanderbilt University Medical Center Slides Keywords Pragmatic Clinical Trials, Cluster-crossover Trial Key Points More than 3 million adults receive invasive mechanical ventilation each year in the U.S.

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pharmaphorum

OCTOBER 3, 2022

Amylyx Pharmaceuticals’ Relyvrio – a new treatment for amyotrophic lateral sclerosis (ALS) approved by the FDA on Thursday, after review of the data from its phase 2 trial – was the next day set at a list price of $158,000 per year in the US, sparking outcry. ALS affects over 30,000 people in the US.

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Rethinking Clinical Trials

NOVEMBER 21, 2023

Patiens were excluded if they had neither a landline or cell phone, were enrolled in hospice or palliative care, were non-English or Spanish speaking, and residing out of the state of Colorado. Discussion Themes -Do you think the results support a text message nudge in most clinical trials and what is the cost effectiveness of this?

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Rethinking Clinical Trials

MAY 10, 2023

More than 631,000 participants have enrolled in All of Us with continued growth. We want to make sure that we are not an off ramp for clinical trials. We want trials to adhere to our core values and have the data come back to our ecosystem. Denny, MD, MS) appeared first on Rethinking Clinical Trials.

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Rethinking Clinical Trials

AUGUST 18, 2022

The Trial Innovation Network Recruitment Innovation Center aims to positively impact human health by improving participant enrollment and retention in multi-center clinical trials. Learn more: Improving Representation in Clinical Trials and Research. Wilkins, MD, MSCI) appeared first on Rethinking Clinical Trials.

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pharmaphorum

JANUARY 9, 2023

Zolgensma meanwhile is now approved in 45 countries, with over 2,500 patients treated globally across clinical trials, managed access programs, and in the commercial setting. ” Zolgensma is one of the most expensive therapies available, with a price tag of around $2.1 Pause in UK access.

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Rethinking Clinical Trials

JULY 13, 2023

For the IMPLEMENT-HF Pivotal Study, 200 hospitalized patients were enrolled at 3 hospital sites in one integrated health care system, where patients either received the virtual care team intervention or usual care. Bhatt, MD, MBA, ScM) appeared first on Rethinking Clinical Trials.

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pharmaphorum

DECEMBER 17, 2021

Biogen and partner Eisai have said they will provide details next March for the confirmatory trial that will be needed to upgrade the drug’s accelerated approval for controversial Alzheimer’s drug Aduhelm to a full one. The post Biogen updates on its confirmatory Aduhelm trial appeared first on.

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pharmaphorum

MAY 10, 2022

As with Aduhelm (aducanumab), lecanemab is being filed via the accelerated approval pathway, with the companies seeking a green light on the strength of the results of a phase 2b trial ahead of the readout of the confirmatory Clarity AD trial, due in the autumn.

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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

FEBRUARY 22, 2023

It will demonstrate that we can do trials at less cost than a normal trial (about 1% of a normal study). The question is can we pivot from very expensive trials to test cardiovascular drugs to at least a hybrid model that takes the best of what we have learned so far from the Heartline Trial?

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Rethinking Clinical Trials

FEBRUARY 2, 2023

The PrePARE Trial tested the initiation of a 500 mL crystalloid fluid bolus before induction in 9 U.S. The trial had 1:1 randomization in blocks of 2, 4, & 6, stratified by site. Discussion Themes – Was there information to the patients so they knew that they were part of the trial? This trial used a mixed approach.

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Rethinking Clinical Trials

MARCH 21, 2023

Goldberg Distinguished Professor and Chief of Oncology Physician-in-Chief, North Carolina Cancer Hospital Director, Cancer Outcomes Research Program University of North Carolina Slides Keywords Patient-reported outcomes, Oncology, Clinical Trials Key Points Symptoms are common in cancer care. Quality of life (QOL) was assessed at 6 months.

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Rethinking Clinical Trials

AUGUST 28, 2023

The IMPACt-LBP study design is a pragmatic, multi-site, two-arm cluster-randomized trial with randomization at the primary care provider (PCP) clinic level. The study team plans to enroll 1,800 adult patients with a primary complaint of LBP who contacted a participating primary care clinic to make an appointment with a primary care provider.

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XTalks

APRIL 29, 2022

Eli Lilly announced that its obesity drug tirzepatide has scored favorably in a late-stage clinical trial, with results showing that people who took the drug lost an average of 50 pounds, or 21 percent, of their body weight compared to placebo. Wegovy had a price tag of $1,297 a month when it was first launched. percent and 22.5

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pharmaphorum

OCTOBER 4, 2022

During the first stage of the initiative, more than 2,000 research papers were published, 49 clinical trials were carried out, and more than 30 patents were filed through the support of the US National Cancer Institute (NCI). Building a bank. The entire process takes place in the physician’s office, alongside a clinician.

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The Pharma Data

NOVEMBER 15, 2020

Clover aims to double its commercial manufacturing capacity in preparation for global Phase 2/3 trials. ” Clover’s COVID-19 S-Trimer vaccine was developed by combining the trimeric SARS-CoV-2 spike (S)-protein with the company’s proprietary Trimer-Tag © technology. SHANGHAI , Nov.

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XTalks

SEPTEMBER 27, 2022

The record-breaking price tag of Skysona is not surprising for one-time gene therapies like it. The price tag reflects “the clinical benefit [it] provides as an urgently needed treatment option to slow the progression of neurologic dysfunction in children impacted by progressive, irreversible and fatal rare disease,” Obenshain added.

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pharmaphorum

DECEMBER 2, 2020

Aside from Gazyvaro, CLL can be treated with older chemotherapy agents, or Roche/AbbVie’s Venclexta (venetoclax) in some instances, and the fast track tag showed the FDA considered the combination to be a promising new contender on the market. TG said it expects the data submission to be complete in the first half of 2021.

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Rethinking Clinical Trials

AUGUST 4, 2022

TOGETHER is a randomized adaptive platform trial that was initiated in June 2020 to investigate the efficacy of repurposed treatments for COVID-19 disease among high-risk adult outpatients. TOGETHER has been through 14 interventions within the trial and has four active arms. Key Points. Discussion Themes. Learn more about TOGETHER.

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Rethinking Clinical Trials

NOVEMBER 9, 2022

Clinical Trial, Medical Education. The goal of the CardioNerds Clinical Trials Network is to pair equitable enrollment with trainee development. Like many trials during the COVID-19 pandemic, there were significant challenges and recruitment delays. Amit Goyal, MD, MAS. Interventional/Structural Fellow, Cleveland Clinic.

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The Pharma Data

MAY 4, 2021

Vaccine effectiveness in the study will be inferred through immunobridging to the 16 to 25 year-old population in the pivotal Phase 3 trial. In March 2021, Pfizer and BioNTech announced topline results from a pivotal Phase 3 trial in adolescents 12 to 15 years of age with or without prior evidence of SARS-CoV-2 infection.

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