Rethinking Clinical Trials

OCTOBER 13, 2022

The HandiCAP trial asked the question do intraoperative handovers of anesthesia care have an impact on patient outcomes? Patients were registered and randomized centrally in a 1:1 ratio to receive either a handover of anesthesia care or no handover. Are the results generalizable to all patient cohorts and to other health care systems?

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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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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. At the time, more than 95% of VA patients received hydrochlorothiazide for thiazide-type diuretic.

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Clinical Trials Clinical Trials Cardiology Trials 152

Rethinking Clinical Trials

NOVEMBER 21, 2022

acutely ill patients) and step-down, which is the extubation or post-extubation part of the care pathway. The FIRST-ABC trial adopted a pragmatic design with a heterogenous patient cohort where the indication to start NRS was based on physiological criteria, which allowed the results to be applicable to all situations where HFNC is started.

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Trials Clinical Trials Clinical Trials Packaging 130

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. Thirty-day mortality was higher in the intervention hospital group.

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Clinical Trials Clinical Trials Trials Development 130

Rethinking Clinical Trials

FEBRUARY 20, 2024

Chair in General Internal Medicine Rutgers, Robert Wood Johnson Medical School Keywords Transfusion; MI; MINT; Anemia; Clinical trials Key Points Anemia is common in patients with acute MI. Due to the lack of evidence, indications for red blood cell transfusion in patients with MI are controversial.

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Trials Clinical Trials Clinical Trials Medicine 130

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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Genetic Engineering Antibody Clinical Trials Clinical Trials 130

Rethinking Clinical Trials

OCTOBER 18, 2023

Other data, such as immunizations, social determinants of health (SDOH), patient-generated data, and others, may or may not be in the PCORnet Common Data Model and require additional work for use in research. When we talk about patient-level SDOH measures, the CDM has some general purpose tables that can store that data.

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Clinical Trials Clinical Trials Clinical Research Research 117

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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Clinical Trials Clinical Trials Trials Development 141

Rethinking Clinical Trials

AUGUST 30, 2023

   Speaker Gabriela Schmajuk, MD, MS Professor of Medicine UCSF and the San Francisco VA Slides Keywords Patient-Reported Outcomes, Rheumatoid Arthritis, EHR Key Points Clinicians rely on patient-related outcomes (PROs) to track disease and function over time in patients with rheumatoid arthritis (RA).

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Trials Clinical Research Coordinator Medicine Clinical Trials 141

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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Trials Clinical Trials Clinical Trials Medicine 130

Rethinking Clinical Trials

JULY 13, 2023

In modeling exercises, optimal implementation of these therapies, such as an ARNI, a beta blocker, an MRA, and an SGLT2 inhibitor, compared to conventional therapy (an ACEi or ARB plus a beta blocker) is estimated to afford more than 6 years of survival in a typical 55-year-old patient. Learn more Read about the IMPLEMENT-HF study in JACC.

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Clinical Trials Clinical Trials Scientist Research 130

Rethinking Clinical Trials

AUGUST 23, 2022

Participating organizations included FDA, NIH, academic institutions, pharmaceutical and device companies, patient advocacy groups, community groups, and data groups, and representatives from each organization had opportunity to extend invitation to others. It was held virtually on April 28-29, 2021. Discussion Themes. -Is

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Clinical Trials Clinical Trials Trials Medicine 130

Rethinking Clinical Trials

OCTOBER 27, 2022

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. ePatient and Security Researcher. Key Points. Learn more.

Clinical Research 130

Clinical Research Research Clinical Trials Clinical Trials 130

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 111

Rethinking Clinical Trials

SEPTEMBER 30, 2022

This was a randomized controlled trial that enrolled 5,670 mothers into the evaluation between 2016 and 2020, with 2/3 allocated to the intervention group. The control group received standard of care in South Carolina. 98% of participants enrolled in the treatment group received at least one visit from NFP.

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Nurses Trials Clinical Trials Clinical Trials 130

World of DTC Marketing

JUNE 23, 2021

SKIMMERS SUMMARY: Jefferies analysts found doctors have shown strong interest in prescribing Aduhelm for about 35% of early-stage Alzheimer’s patients with mild cognitive impairment after surveying 50 U.S. neurologists or psychiatrists currently treating about 12,000 Alzheimer’s patients. Not to mention the $56,000 annual price tag.

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pharmaphorum

APRIL 26, 2021

Teijin Pharma is part of Teijin Group, a multinational offering services in high-performance materials, healthcare including pharma and IT. 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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Development Medicine Production Marketing 122

pharmaphorum

NOVEMBER 16, 2021

NHS patients in England and Wales with drug-resistant epilepsy are in line for access to another treatment option, after NICE recommended routine use of Angelini group company Arvelle Pharma’s Ontozry. The drug was eventually cleared in the EU in April, with the UK giving it a green light in June.

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Drugs Medicine Clinical Trials Clinical Trials 98

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. The study does not include tissue specimen collection, image submission, or patient-reported outcome instruments.

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Clinical Trials Clinical Trials Trials Packaging 130

Rethinking Clinical Trials

SEPTEMBER 28, 2023

The PARENT group added interventions such as a community health worker “parent coach,” a pre-visit tool to help identify parent priorities, a text message service to keep in touch between visits, and a brief, focused clinician visit. Parents loved the text messaging service.

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Trials Clinical Trials Clinical Trials Research 269

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. All patients could receive inhalation NO during/after surgery if considered indicated by the treatment team. All other surgical staff were blinded.

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Trials Clinical Trials Clinical Trials Research 130

pharmaphorum

DECEMBER 12, 2022

Updated results from the ADVANCE IV study of Vyvgart (efgartigimod alfa) showed that more than half of patients with ITP treated with Argenx’ drug showed an improvement in platelet counts, which are dramatically reduced in the disorder. After 24 weeks, 21.8% After 24 weeks, 21.8% All told, 51.2%

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Sales Trials Drugs Antibody 52

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. All patients in the ED and ICU were assigned together to an SpO2 target. The sample size was 2,250 patients over 36 months.

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Trials Clinical Trials Clinical Trials Development 130

XTalks

DECEMBER 13, 2023

Sickle cell disease is a group of inherited red blood cell disorders that affect approximately 100,000 people in the US, most of whom are Black. Current treatments for sickle cell disease include blood transfusions but patients often have episodes of intense pain and an increased risk of stroke.

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Gene Therapy FDA Approval Gene In-Vivo 98

XTalks

JANUARY 28, 2022

Up to 50 percent of patients will develop metastatic disease, mainly spreading to the liver, making treatment difficult and limited. Kimmtrak has a price tag of $18,760 per vial, which amounts to a weekly dose. months), so the average cost per patient will be approximately $400,000.

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FDA Approval Development Licensing Licensing 98

Rethinking Clinical Trials

JANUARY 19, 2023

But this might obscure heterogeneity within groups, intersecting sources of vulnerability, and other vulnerable participants, such as people with dementia. – What if a patient has capacity to consent but their surrogate disagrees? That’s difficult. it can be a barrier.

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Trials Clinical Trials Clinical Trials Research 130

The Pharma Data

NOVEMBER 29, 2021

1.1.529 a variant of concern, named Omicron, on the advice of WHO’s Technical Advisory Group on Virus Evolution (TAG-VE). Effectiveness of current treatments : Corticosteroids and IL6 Receptor Blockers will still be effective for managing patients with severe COVID-19. On 26 November 2021, WHO designated the variant B.1.1.529

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Vaccination Vaccine Genome Genomics 52

XTalks

JUNE 8, 2021

Novartis’ Zolgensma (onasemnogene abeparvovec) gene therapy has been making significant strides as of late, including dosing of the first Spinal Muscular Atrophy (SMA) patient with the treatment in the UK last week. With a price tag of over $2.5 Baby Arthur: First UK Patient.

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Gene Therapy Gene Protein Trials 110

pharmaphorum

MARCH 23, 2022

Vyvgart (efgartigimod alfa) became the first drug in the FcRn class to be approved by the FDA last December, and despite a $225,000 annual price tag is predicted to make relatively modest sales in its IV version, which will compete with other IV gMG drugs like AstraZeneca/Alexion’s C5 inhibitor Soliris (eculizumab). in the IV arm.

Antibody 52

Antibody Sales FDA Approval Trials 52

Intouch Solutions

APRIL 11, 2024

Commercial : Improved experience and communication between patients and doctors. In the pharma industry, precision engagement can be used to present patients, healthcare professionals (HCPs), and other stakeholders with relevant information and support at the right time. It uses customer insights to deliver personalized experiences.

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Compliance Marketing Drugs Pharma Companies 52

pharmaphorum

APRIL 5, 2022

Kimmtrak (tebentafusp) has been cleared to for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma (mUM), mirroring its label in the US. Uveal melanoma is a rare cancer of the eye, which in the majority of patients is localised.

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Protein Sales Drugs Trials 52

Drug Discovery World

JANUARY 30, 2024

To achieve this, we need greater collaboration between academia, therapy developers and manufacturing equipment developers.” Stella Vnook , CEO, Likarda , notes that a s more regenerative therapy options come to the market, patients will demand access to the treatments, often using the court system. She

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Gene Therapy Manufacturing Gene Clinical Trials 71

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. The post Enhertu gets breakthrough tag in HER2-low breast cancer appeared first on. billion. .”

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Sales Drugs Antibody Licensing 59

pharmaphorum

MAY 17, 2021

There had been speculation that the FDA might approve Empaveli (pegcetacoplan) only as a backup option for patients who don’t see a sufficient benefit with Alexion’s Soliris (eculizumab) or Ultomiris (ravulizumab), but the regulator opted for a broad indication that included first-line treatment for PNH. billion and $1.1

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Drugs FDA Approval Marketing Clinical Trials 52

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. Virtual connections. Engagement channels. Regulated industry learnings.

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Regulation Marketing Sales Branding 97

pharmaphorum

NOVEMBER 24, 2022

The phase 3 ESCAPE-TRD study in 676 patients revealed that significantly more of those treated with Spravato were able to achieve remission from symptoms of depression without a relapse over 32 weeks of follow-up compared to quetiapine. and 14.1%, respectively.

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