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Grand Rounds January 12, 2024: Design and Implementation of a Weighted Lottery to Equitably Allocate Scarce Covid-19 Resources (Erin K. McCreary, PharmD, BCIDP)

Rethinking Clinical Trials

The first drug that used the new process was Remdesivir in May 2020. The committee worked with communications specialists who partnered with palliative care providers and others to draft FAQs and other communication guidance for clinician teams who were having conversations about drug allocations with patients and families.

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Grand Rounds October 27, 2023: Digital, Decentralized and Democratized: Lessons From The Yale PaxLC Trial (Harlan M. Krumholz, MD, SM)

Rethinking Clinical Trials

Participants should have access to investigators and the results of studies. A lot of participants have worked with their physician to stop a drug so they can participate. One of the main reasons we turn people away is because they are taking a medication that does not work with Paxlovid.

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Grand Rounds July 22, 2022: ACTIV-6: 1-Year Later and Trial Results for Ivermectin-400 and Inhaled Fluticasone (Susanna Naggie, MD, MHS)

Rethinking Clinical Trials

ACTIV-6 is testing medication doses approved by the FDA for other purposes, i.e., repurposed drugs. Given the history with other repurposed drugs, I was concerned people would not want to take Ivermectin. This was one of the reasons we gave people options about which drugs they were willing to take. Susanna Naggie, MD, MHS.

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Grand Rounds February 2, 2024: Strategies for Improving Public Understanding of FDA and the Products It Regulates…Why Should We Care, and What Might We Do? (Susan C. Winckler, RPh, Esq)

Rethinking Clinical Trials

Winckler, RPh, Esq Chief Executive Officer Reagan-Udall Foundation for the FDA Slides Keywords U.S. Food and Drug Administration, FDA, Misinformation, Communication, Health Information Key Points U.S.             Speaker Susan C.

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Grand Rounds October 20, 2023: A National Initiative to Eliminate Hepatitis C in the United States – Why This Matters to Clinical Trialists (Rachael L. Fleurence, PhD, MSc; Joshua M. Sharfstein, MD)

Rethinking Clinical Trials

There is now a cure for Hepatitis C, but many people are not able to access it. point of care diagnostic tests, provide broad access to curative Hepatitis C medications with a national subscription model, with Medicare co-pay assistance and commercial insurance coverage. Rates are the highest among 20-39-year-olds.

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Grand Rounds June 30, 2023: Decentralized Trials – From Guidance to Reality & What’s Left (Adrian Hernandez, MD, MHS; Pamela Tenaerts, MD, MPH; Craig Lipset, MPH)

Rethinking Clinical Trials

Over the past several years, a variety of factors have accelerated the need for decentralized trials, including the push to make trials more accessible, the increased speed of science, the possibility of environmentally conscious trials, and the need to be flexible in a rapidly changing world.

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Novel method predicts if COVID-19 clinical trials will fail or succeed

Bioengineer

In order to win the battle against COVID-19, studies to develop vaccines, drugs, devices and re-purposed drugs are urgently needed. Although drug features and study keywords were the most informative features, all four types of features are essential for accurate trial prediction.