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. The primary outcome is blood pressure at 6 months.

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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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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. Patient recruitment is through a network of sites in different geographic locations managed by a collaboration of AROs. EVOLVE-MI is enrolling 4,000 patients in 3 countries.

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Rethinking Clinical Trials

FEBRUARY 16, 2023

There are also concerns that obtaining consent could alter the “real-world” medical care being studied, may introduce an alteration of routine care, may introduce bias or make research impossible to conduct. ICD-Pieces studied patients with chronic kidney disease (CKD), diabetes and hypertension. Pearl O’Rourke, MD; David S.

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Rethinking Clinical Trials

OCTOBER 13, 2022

Department of Anesthesiology, Intensive Care and Pain Medicine. There is an increasing frequency of surgical procedures and the need for anesthesia care, and the number of care transitions is increasing. The HandiCAP trial asked the question do intraoperative handovers of anesthesia care have an impact on patient outcomes?

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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. Every patient with COVID-19 was automatically considered. Patients were screened by local teams at each site.

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Rethinking Clinical Trials

JULY 6, 2023

For instance, there is no discussion of the role of the health care provider in the DCTs, but it emphasizes the importance of patient voice. The key remaining issues for DCTs include clarification around the roles and responsibilities of health care providers as well as principal investigator (PI) oversight and responsibility.

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pharmaphorum

OCTOBER 18, 2022

Medtech giant Beckton Dickinson (BD) has signed a deal with France’s Biocorp to use the latter’s near-field communication (NFC) tags in injectable devices. The Injay tag can confirm a complete injection and transfer that information via an NFC reader to a smartphone or tablet for review by a healthcare professional.

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Drug Delivery Manufacturing Drugs Marketing 52

Pharmaceutical Technology

MAY 2, 2023

Immuno-oncology (IO) agents have transformed the cancer therapeutics landscape, driving long-term remissions in a subset of patients who historically had limited options. Although a subset of patients derives long-term benefits from IO therapies, a high percentage of patients still fail to respond or develop resistance to IO therapy.

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Rethinking Clinical Trials

APRIL 27, 2023

The reasoning for this temperature is unclear, though it likely represents what was considered the average body temperature of most patients. 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

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Pharmaceutical Technology

APRIL 13, 2023

Although the findings in the report are only preliminary, they shed light at the considerations behind the high price tags of gene therapies. The standard of care for the condition includes blood transfusions, hydroxyurea and iron chelation. million to achieve $150,000 per QALY gained from a healthcare system perspective.

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Gene Therapy Gene FDA Approval Licensing 147

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 21, 2023

The Nudge study wanted to find out if nudges could help patients improve medication adherence by promoting behavioral change through positive reinforcement. The Year 1, UG3 Phase, aims were to develop and program a nudge message library using iterative N of 1 studies to optimize content for a range of diverse patients.

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World of DTC Marketing

SEPTEMBER 24, 2021

This drug was never about patients; it was about a company whose ego got too big and needed a savior in the form of a medicine that could bring in hundreds of millions of dollars. Many doctors also became upset at the idea of telling Alzheimer’s patients that the drug didn’t work. Biogen is in trouble.

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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.

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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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World of DTC Marketing

NOVEMBER 3, 2020

and $20 billion in health-care costs. An #NHLBI-funded study put a price tag on American’s bad eating habits: $50 billion a year in health care costs, attributable to cardiometabolic diseases such as heart disease, stroke and type 2 diabetes. According to STAT News “Americans consume an average of 1.5

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Pharma Companies Scientist Medicine Research 190

Rethinking Clinical Trials

OCTOBER 26, 2023

Many people do not know they have Hepatitis C (about 40% of patients). 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. The initiative would bring to the U.S.

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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. All patients in the ED and ICU were assigned together to an SpO2 target.

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Rethinking Clinical Trials

FEBRUARY 13, 2023

All patients could receive inhalation NO during/after surgery if considered indicated by the treatment team. There was no change in perioperative care. 1,371 patients were randomized with 1,364 in the final analysis. The intervention was applied by perfusionists at a steady concentration from the start until the end of bypass.

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Rethinking Clinical Trials

MARCH 6, 2024

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. They also screened for complications and close care gaps. Clinic staff included a dietitian, a nurse and a community health worker.

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Pharmaceutical Technology

MAY 1, 2023

CTH-004 is developed by genetically altering patient T cells for inserting a chimeric antigen receptor (CAR) to target a marker (TAG-72) on ovarian cancer cells and delete genes which are involved in T cell function suppression. Shunxi will also hold an option to negotiate rights to other CAR-T products, which include the licenced IP.

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Rethinking Clinical Trials

SEPTEMBER 16, 2022

The LHS were identified by AAMC Research on Care Community, self-descriptions, and snowball referrals, and they included LHS that are medical school affiliated and non-affiliated, safety net systems, and children’s hospitals. How are patients and families included in governance of learning within your LHS? Learn more.

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Rethinking Clinical Trials

JULY 22, 2022

Since the protocols have launched, 20,000+ patients have enrolled at more than 620 sites across numerous networks, 11 protocols were developed, 10 launched, with 26 publications across 13 journals. Six agents showed really good results and either changed clinical practice or showed efficacy and improved patient care.

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Rethinking Clinical Trials

JULY 27, 2022

It is a decentralized, fully remote trial, and data are largely patient reported. There were no differences observed in the relief of mild-to-moderate COVID-19 symptoms between patients taking Ivermectin-400 and the placebo. Were there concerns about having patients not associated with a site? No safety concerns were identified.

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Rethinking Clinical Trials

MARCH 1, 2023

S1800A was a Phase II randomized study of ramucirumab plus pembrolizumab versus standard of care for NSCLC patients previously treated with immunotherapy performed within the Lung-MAP platform. months, for pembrolizumab and ramucirumab vs. standard of care, respectively.

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Rethinking Clinical Trials

OCTOBER 27, 2022

Health care and the internet are intertwined. Patients use the internet to search for answers, and researchers use the internet to search for new solutions. The Light Collective is an organization that represents collective rights, interests, and voices of patient communities in healthcare technology. Andrea Downing. Key Points.

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Rethinking Clinical Trials

AUGUST 10, 2023

However, gamification could have serious negative effects, and the benefits of these games in health care would relate to how well or how poorly they’re gamified, based on data, execution, and use cases. Tags #pctGR, @Collaboratory1 The post Grand Rounds August 4, 2023: AI & ML: Want to Play a Game?

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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. For PCTs, data volume is potentially larger, data may be “about” those beyond patient-subjects (i.e.

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pharmaphorum

JANUARY 5, 2022

The FDA thinks an antibody-drug conjugate (ADC) developed by AbbVie could set new standards in treatment for certain patients with lung cancer, awarding the drug breakthrough status. overall response rate (ORR) in patients with high levels of c-Met expression, and 25% in those with intermediate levels, showing proof of concept for the ADC.

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Antibody Drugs Protein Gene 110

Rethinking Clinical Trials

SEPTEMBER 30, 2022

The types of services NFP nurses provide include health assessments, such as prenatal health assessment, monitoring weight and blood pressure; screening for depression, anxiety, intimate partner violence; referrals to health care providers and community resources; educational content; and psychosocial support. pctGR, @Collaboratory1.

Nurses 130

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pharmaphorum

APRIL 26, 2021

It also develops services to support the evolution of medical care and finding purposes in life, in collaboration with various research institutions and companies. In 2019 Cognitant and Addenbrook’s Hospital in Cambridge, UK piloted a programme that aimed to educate patients to improve adherence to rheumatoid arthritis medicines.

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Rethinking Clinical Trials

FEBRUARY 9, 2023

This trial tested the hypothesis that the use of a platform-agnostic, EHR-embedded VTE risk model with integrated CDS would 1) increase rates of appropriate Thromboprophylaxis, and subsequently 2) reduce thromboembolism, compared to usual medical care in hospitalized, medically-ill patients.

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World of DTC Marketing

SEPTEMBER 7, 2022

In pharma, growth depends on new products with hefty price tags when over 80% of voters want lower costs for their prescription drugs. For DTC, the model will become one of collaboration with patients as they help them navigate the complex system of American healthcare. ” The U.S.

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Rethinking Clinical Trials

DECEMBER 6, 2022

This study asks how can we better facilitate health behaviors in patients with chronic diseases and can we leverage technology? that focused on patients with heart failure and diabetes, two rapidly growing conditions that are highly morbid. There was 1:1 randomization of participants to either the mHealth intervention or usual care.

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Rethinking Clinical Trials

FEBRUARY 28, 2024

Outcomes including patient reported outcomes, functional assessments including via digital technology, healthcare events or mortality may require identify verification. The skills may also vary between trials and getting participants the care they need.

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pharmaphorum

DECEMBER 23, 2021

The designation – which is awarded to therapies that could represent a significant improvement over standard of care in either efficacy, safety, or both – has been awarded on the strength of phase 1 results in patients with metastatic or locally advanced EGFR-mutated non-small cell lung cancer (NSCLC).

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