Rethinking Clinical Trials

MAY 19, 2023

The team’s goals were to design for the primary care setting because 85% of hypertension care is in this setting. Later this year, the study team will launch the COACH trial, a pragmatic clinical trial with 550 adult primary care patients with uncontrolled hypertension who are portal users.

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Rethinking Clinical Trials

NOVEMBER 21, 2022

Reader in Pediatric Critical Care. The difficulty with pediatric respiratory support is that the step-up and step-down of respiratory care is very evidence poor even though these therapies are used commonly. acutely ill patients) and step-down, which is the extubation or post-extubation part of the care pathway. Key Points.

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Rethinking Clinical Trials

FEBRUARY 13, 2023

There was no change in perioperative care. The primary outcome was ventilator-free days (VFD) from start of cardiopulmonary bypass to day 28, with a number of secondary outcomes. All patients could receive inhalation NO during/after surgery if considered indicated by the treatment team. There were a number of limitations.

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Rethinking Clinical Trials

OCTOBER 26, 2023

There is a lack of point-of-care diagnostics; it can take up to 3 steps to treatment initiation. The treatment is not a routine part of primary care, and there is an underserved and hard-to-reach population. Many people do not know they have Hepatitis C (about 40% of patients). The initiative would bring to the U.S.

Clinical Research 141

Clinical Research Clinical Trials Clinical Trials Research 141

Rethinking Clinical Trials

SEPTEMBER 13, 2023

DEVICE, part of the Pragmatic Critical Care Research Group, was a multicenter, parallel-group, unblinded pragmatic, randomized trial compared the use of a video laryngoscope with the use of a direct laryngoscope for tracheal intubation of critically ill adults at 17 EDs and ICUs across U.S.

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Trials Clinical Trials Clinical Trials Medicine 141

Rethinking Clinical Trials

AUGUST 4, 2022

For the overall trial, anyone over the age of 18 with a known risk factor for disease progression is eligible; they have to present at an outpatient care setting with an acute clinical condition consistent with COVID-19 and have a positive rapid test in the clinic. 43% risk reduction for hospitalization (65% reduction when treated early).

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Rethinking Clinical Trials

JULY 14, 2023

GGC4H is a 5-year, longitudinal cluster-randomized trial that took place in pediatric primary care. 3) Is virtual GGC satisfying to parents and 4) What do health care system leaders say? GG4CH identified strengths of the intervention and barriers through interviews with health care system leaders.

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Clinical Trials Clinical Trials Trials Research 130

Rethinking Clinical Trials

JULY 9, 2023

BeatPain Utah, an NIH Pragmatic Trials Collaboratory Demonstration Project, is an embedded pragmatic clinical trial comparing the effectiveness of nonpharmacologic intervention strategies for patients with back pain seeking care in federally qualified health centers in Utah.

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Clinical Trials Clinical Trials Trials Research 130

Rethinking Clinical Trials

JANUARY 26, 2023

Participants within 10 days of index MI will either receive Evolocumab (140mg Q2W) every two weeks plus routine clinical care or standard of care. The primary endpoint is a composite of total events including first and recurrent MI, ischemic stroke, any arterial revascularization, and death from any cause.

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Trials Clinical Trials Clinical Trials Medicine 130

Rethinking Clinical Trials

MARCH 6, 2024

They also screened for complications and close care gaps. The primary outcome was HbA1c after 6 months. The dietician met with the patient to share education about nutrition, portion size, recipes to make food taste good, and information via an optional diabetes self-management program. The intervention group started the program now.

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Clinical Trials Clinical Trials Medicine Trials 141

Rethinking Clinical Trials

FEBRUARY 7, 2024

The primary finding is that clear consistent communication both to consumers directly and via medical channels is critical to the FDA’s mission to protect and promote public health. Potential strategy: Increase regular communication with health care professionals. Winckler, RPh, Esq) appeared first on Rethinking Clinical Trials.

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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 drugs were administered open label and all patients were given a low dose of aspirin.

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Clinical Trials Clinical Trials Trials Cardiology 130

Rethinking Clinical Trials

FEBRUARY 28, 2024

Was there complete ascertainment of primary and secondary efficacy data? Was there complete ascertainment of primary and secondary safety data? The skills may also vary between trials and getting participants the care they need. Did participants receive the assigned treatment and did they stay on the treatment?

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Clinical Trials Clinical Trials Trials Clinical Research 141

Rethinking Clinical Trials

APRIL 27, 2023

In a recent international survey of more than 270 centers, nearly half now use a cooler temperature dialysate in patient care of less than or equal to 36.0 The primary composite outcome was cardiovascular mortality or hospital admission with MI, stroke, or heart failure. standard) temperature dialysate is beneficial.

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Trials Clinical Trials Clinical Trials Medicine 130

Rethinking Clinical Trials

JULY 19, 2023

The first group consisted of a usual care arm, where they received basic guidelines for treating diabetes or ASCVD. About 6-12 months after enrollment, patients were assessed for the primary outcome, which was the prescription of all 3 recommended therapies. In the usual care arm sites, 14.5% In the usual care arm sites, 14.5%

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Rethinking Clinical Trials

NOVEMBER 16, 2022

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. – How can we include diverse communities in this discussion especially in terms of trust? pctGR, @Collaboratory1.

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Clinical Trials Clinical Trials Trials Research 246

Rethinking Clinical Trials

MAY 5, 2023

Yet, even though millions of patients have received oxygen during mechanical ventilation in clinical care for decades, the oxygen target that optimizes outcomes has been unknown. There are 3 basic approaches to oxygenation targets in clinical care. The secondary outcome was in-hospital mortality. For many patients, this did not happen.

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Trials Clinical Trials Clinical Trials Development 130

Rethinking Clinical Trials

DECEMBER 6, 2022

The primary endpoint was change in mean daily step counts from baseline to 3 months. There was 1:1 randomization of participants to either the mHealth intervention or usual care. For the step-down RCT, patient recruitment started in August 2019 with 587 patients consenting and 552 included in the primary analysis.

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Trials Clinical Trials Clinical Trials Compliance 130

XTalks

FEBRUARY 27, 2024

Recent FDA Approvals of New Rare Disease Drugs Filspari (sparsentan) for primary immunoglobulin A nephropathy (IgAN), a rare kidney disease, marking it as the first non-immunosuppressive therapy for the condition. Sarepta hopes to clarify Elvidys’ effectiveness in older children in a confirmatory trial.

Research 59

Research Drugs Gene Therapy Clinical Trials 59

pharmaphorum

AUGUST 17, 2020

In this article Joanna Carlish, managing director of financial services at Tag Americas , and Robb DeFilippis, Tag Americas’ managing director, life sciences, go head-to-head to discuss marketing within a regulated industry. Joanna Carlish, managing director, financial services, Tag Americas. Virtual connections.

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Regulation Marketing Sales Branding 78

Roots Analysis

JANUARY 28, 2024

Velocity: Big Data needs to be handled promptly as businesses generate data at an unprecedented speed, driven by the growing adoption of Internet of Things (IoT), and technologies, such as RFID tags, sensors, and smart meters are used to deal with the high velocity of data in real-time. It is loosely arranged into categories using meta tags.

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Big Data Medicine Marketing Clinical Trials 40

Rethinking Clinical Trials

SEPTEMBER 22, 2022

Hospitalization of flu is the primary outcome. These one-time interventions, like vaccines, contact people, deliver intervention, what about chronic care that is needed for a trial where more monitoring is needed? The team will send out 800,000 invitations. million citizens will be randomized to receive 10 different communications.

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XTalks

OCTOBER 26, 2021

After initial rejection from the National Institute for Health and Care Excellence (NICE) last year, the non-departmental public body of the Department of Health in England has now given the green light to the gene silencing treatment Givlaari (givosiran) for the treatment of the rare metabolic disorder, acute intermittent porphyria (AIP).

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Gene Silencing Gene Clinical Trials Clinical Trials 98

Intouch Solutions

JULY 27, 2021

And 17%, or 56 million Americans, can be considered “medically disenfranchised,” with inadequate access to a primary care doctor. The majority of new products coming to market are specialty drugs targeting rare diseases and new breakthrough approaches to cancer treatment – but innovation comes with large price tags.

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Drugs Marketing Vaccination Vaccine 52

Intouch Solutions

APRIL 11, 2024

Consequently, they are compelled to reorganize their schedules, reducing the time they have for ongoing education and caring for patients. In the past, multiple virtual assistants were launched by companies but encountered limited success for two primary reasons: The overall experience was good but not as seamless as the HCPs were expecting.

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Compliance Marketing Drugs Pharma Companies 52

pharmaphorum

JANUARY 31, 2023

This discrepancy can be caused by a variety of factors, however, one of the primary and most solvable ones is patient non-adherence to their medications. Given the high price tags placed on many medications, it’s easy to understand why patients often feel that they are being taken advantage of.

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Clinical Trials Clinical Trials Trials Vaccination 52

XTalks

JUNE 8, 2021

With a price tag of over $2.5 In March, the National Institute for Health and Care Excellence (NICE) and the Scottish Medicines Consortium in Scotland both recommended that the gene therapy be used by the NHS for babies up to the age of 12 months with type I SMA. million, Zolgensma is currently the world’s most expensive drug.

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Gene Therapy Gene Protein Trials 110

Delveinsight

DECEMBER 3, 2020

It has been speculated that modifications to the epigenome drive cell ageing, especially a process known as DNA methylation, by which methyl groups are tagged onto DNA. A phase 3 trial of Ovid Therapeutics’ OV101 in Angelman syndrome has flunked its primary endpoint. points, which leads to the miss of its primary endpoint.

Gene Therapy 52

Gene Therapy Gene Antibody Research 52

Delveinsight

JULY 22, 2020

Today the tech-based healthcare industry is providing many unique solutions to the patient’s care which are more efficient and effective than the traditional services. Sensors/Devices are the primary data collection point in IoT. Emergency Care. The hospital inventory is equipped with tagged sensors.

Doctors 59

Doctors Doctor Marketing Production 59

XTalks

AUGUST 23, 2021

As diagnostic methods for MS improved, patients in earlier stages of the disease with milder symptoms became the primary population enrolled in studies. Trials must be designed to address the current standard of care,” said Dr. Grill. “We This is another case in which careful clinical trial design is of the utmost importance.

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Clinical Trials Clinical Trials Trials Drugs 52

pharmaphorum

MAY 24, 2021

Robb DeFilippis, managing director, life sciences, for end-to-end global creative production and sourcing partner Tag in the Americas agrees. One of the primary lessons that we’ve learned is that it’s all about collaboration. He adds: “One of the primary lessons that we’ve learned is that it’s all about collaboration.

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Marketing Branding Sales Life Science 79

XTalks

JANUARY 19, 2024

This is because they’re in that sweet spot of LET that they don’t care much about how much oxygen there is and can use dominant double-stranded breaks to maximize cell kill, explained Dr. Nawaz. Renal Radiation Limits The renal route is typically the primary clearance pathway for therapeutic radiopharmaceuticals.

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DNA Radiology FDA Approval Development 66

Pharma Marketing Network

OCTOBER 4, 2020

I think, SEO there’s really people used to know, there’s three primary components to SEO. Don (PMN): All right thanks so much vlad, take care. Vlad (LI): Great that you want to kick it off. Vlad (LI): Thank you so much and I look forward to talking to you guys and see how we can support. Listen to this podcast, Ep.

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Doctors Doctor Marketing Packaging 52

The Pharma Data

MAY 4, 2021

Both doses of abrocitinib met the co-primary study endpoints. This follows the announcement in February 2021 of the publication in NEJM of the Phase 3 LIBERTY 1 and LIBERTY 2 studies, which also met their primary endpoints. mg and norethindrone acetate 0.5 mg) in healthy women ages 18-35 who are at risk for pregnancy. Source link.

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Vaccination Vaccine Production Sales 40

Pharma Marketing Network

JUNE 8, 2020

Unfortunately, having had ten friends my age or younger die by the time I was 40 gave me a very unique look into health care and some of the devastating impacts of it. We are now in a 20-yearlong economic depression for the working and middle class as a result of health care prices inflating, prices not cost.

HR 40

HR Marketing Doctors Doctor 40

World of DTC Marketing

JUNE 16, 2021

The pharma industry has been riding a wave of public approval since they developed a vaccine to fight COVID-19, but that goodwill is going to be short lived thanks, in part, to the $56,000 price tag of Biogen’s new drug and insulin that too many people still can’t afford. Pharma’s primary customers is Wall Street.

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