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Grand Rounds February 24, 2023: S2302 Pragmatica-Lung: New Directions for Decreasing Burden and Increasing Inclusion in NCTN Clinical Trials (Konstantin Dragnev, MD; Karen Reckamp, MD, MS)

Rethinking Clinical Trials

To reduce the burden on sites, the study has simplified data reporting by reducing time points data, reducing the number of forms that need to be submitted, and reducing the number of data elements within a form.

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Grand Rounds May 12, 2023: Design and Pragmatic Trial of COACH: A Patient Portal/EHR Information System for Home Blood Pressure Monitoring in Hypertension (Richelle J. Koopman, MD, MS)

Rethinking Clinical Trials

The data visualization started with a basic list of information needed, including systolic and diastolic data; clinic and home data; raw data numbers, effect of medications on blood pressure; goal ranges; out of range values; customizable goal ranges; patient burden of entry; data variability relative to control, and contextual life event data.

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Perfusion MRI and Other Perfusion Imaging Techniques for Clinical Trials

XTalks

We [Philips Pharma Solutions, formerly BioTel Research] have successfully ran multi-site DCE-MRI trials,” said Edward Ashton, PhD, VP, Oncology Imaging, Philips Pharma Solutions. For ASL MR perfusion, water molecules in arterial blood from a feeder artery are magnetically tagged and tracked until they reach the region of interest.

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Hemgenix Approved as First Gene Therapy for Hemophilia B

XTalks

UniQure will manufacture Hemgenix at its Lexington, Massachusetts site. He said the approval “represents important progress in the development of innovative therapies for those experiencing a high burden of disease associated with this form of hemophilia.”. As part of the deal, uniQure can also receive up to $1.5

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How data is crucial to the relaunch of the Cancer Moonshot

pharmaphorum

The trio are charged with helping to enrol patients across more than 100 clinical sites in the US, with the purpose of engaging and educating study volunteers on the process, collecting the patient information accurately and securely, and enrolling patients onto the project itself.

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Life Sciences 2022 Year in Review

XTalks

The multi-million-dollar price tags are largely attributable to the high R&D and manufacturing costs associated with making a gene therapy, as the raw materials for producing the therapy can be expensive. The pandemic necessitated a shift to off-site, remote and virtual clinical trial options. million for a single infusion.

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The “Medical Bypass”: new drugs to strike obesity

Pharmaceutical Technology

High rates of obesity place a major burden on healthcare systems as the condition is associated with many major health complications like type 2 diabetes, hypertension, non-alcoholic fatty liver disease, and other bodily dysfunctions. A 2017–2018 National Health and Nutrition Examination Survey (NHANES), showed that 30.7% had severe obesity.

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