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Grand Rounds July 15, 2022: Overview of Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) Public-Private Partnership and Lessons Learned (Stacey J. Adam, PhD)

Rethinking Clinical Trials

ACTIV was stood up in about a month, launching on April 17, 2020, to develop a coordinated research response to speed COVID-19 treatment and vaccine options. There were four ACTIV fast-track focus areas: vaccines, preclinical, clinical trial capacity, and therapeutics – clinical. ACTIV, COVID-19, FNIH. Key Points.

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Grand Rounds October 28, 2022: The HERO (Healthcare Worker Exposure Response & Outcomes) Program: An Online Community to Support Observational Studies, Randomized Trials, and Long-Term Safety Surveillance (Emily O’Brien, PhD, FAHA; Russell Rothman, MD, MPP)

Rethinking Clinical Trials

Important issues early on included COVID-19’s effects on the workplace, vaccine access and willingness, and impact on home life. The HERO TOGETHER study leveraged the HERO Registry to estimate real-world incidence of safety events among vaccinated individuals. Russell Rothman, MD, MPP. Vanderbilt University Medical Center. Key Points.

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Grand Rounds September 16, 2022: Using Nationwide Registries to Conduct Pragmatic Randomized Trials: The DANFLU Program (Tor Biering-Sørensen, MD, PhD, MPH)

Rethinking Clinical Trials

The DANFLU-1 trial is a large-scale pragmatic RCT that looked at high-dose vs standard-dose flu vaccine to test whether high-dose vaccines might reduce hospitalizations among the elderly, age 65 and older. The aim is to test communication strategies for optimizing the update of the flu vaccine. University of Copenhagen.

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Grand Rounds July 28, 2023: How Can Researchers Fight Misinformation About Medicine? (Carl T. Bergstrom, PhD)

Rethinking Clinical Trials

Bergstrom, PhD Professor, Department of Biology University of Washington Slides Keywords Research, Misinformation, Media, Social Media Key Points Misinformation abounds in medicine and about medicine. If you’re working on a paper about vaccine safety, you have to understand the conversation about vaccine safety.

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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. – Were you able to examine responses from groups that can be particularly challenging such as vaccine deniers and climate change skeptics?             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 are possible clinical research components that would include research on treatment during pregnancy, vaccine development, and implementation model research. with the rate of reported acute Hepatitis C cases increasing 400% during 2010-2020.

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Grand Rounds Ethics and Regulatory Series December 9, 2022: The Stepped Wedge Cluster Randomized Trial: Friend or Foe? (Monica Taljaard, PhD; David Magnus, PhD)

Rethinking Clinical Trials

Raffin Professor of Medicine and Biomedical Ethics and Professor of Pediatrics, Medicine, and by courtesy of Bioengineering. Director, Stanford Center for Biomedical Ethics. Associate Dean for Research. Ethics, Stepped Wedge Cluster Randomized Trial, Study Design. Key Points.

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