Remove tag vaccine-trials
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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

Professor in Translational Cardiology and Pragmatic Randomized Trials. Head of Center for Translational Cardiology and Pragmatic Randomized Trials. DANFLU-1, Pragmatic Clinical Trials. The DECODE trial used registry data to identify patients with chronic kidney disease. Tor Biering-Sørensen, MD, PhD, MPH. Key Points.

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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. pctGR, @Collaboratory1.

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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 first trial undertaken by the HERO Program, HERO-HCQ, evaluated the efficacy of hydroxychloroquine (HCQ) to prevent COVID-19 in healthcare workers. No statistically significant benefit was found.

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A broad range of unmet needs remains in the immuno-oncology space

Pharmaceutical Technology

IO agents include the classes of immune checkpoint modulators, cell therapies, bispecific antibodies, oncolytic viruses, therapeutic vaccines, and cytokines. Oncolytic viruses, cytokines, and therapeutic vaccines currently play a very minimal role in oncology treatment, with substantial efficacy still to be demonstrated for these classes.

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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

Ethics, Stepped Wedge Cluster Randomized Trial, Study Design. There are two main types of clinical trials: patient randomized trial and cluster randomized trial (CRT). – Should we be allowing stepped wedge trials in the Collaboratory? Associate Dean for Research. Key Points. Discussion Themes.

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Clover Biopharmaceuticals Announces Publication of Phase 1 Clinical Trial Data for its Adjuvanted COVID-19 Vaccine Candidates in The Lancet

The Pharma Data

Adjuvanted S-Trimer COVID-19 vaccine candidates demonstrated favorable safety and tolerability profiles and strong neutralizing immune responses in a phase 1 trial. The phase 1 clinical trial was a randomized, double-blind and placebo-controlled study in 150 adult and elderly participants.

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Clover Biopharmaceuticals Announces Positive Phase 1 Data for its Adjuvanted S-Trimer COVID-19 Vaccine Candidates

The Pharma Data

The Phase 1 trial was a randomized, observer-blind, placebo-controlled study to assess the safety, reactogenicity and immunogenicity of the adjuvanted COVID-19 S-Trimer vaccine candidates formulated with different antigen levels. No serious adverse events related to the vaccine candidates studied were reported.