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Grand Rounds Ethics and Regulatory Series November 11, 2022: Data Sharing and Pragmatic Clinical Trials: Law & Ethics Amidst a Changing Policy Landscape (Stephanie Morain, PhD, MPH; Kayte Spector-Bagdady, JD, MBioethics)

Rethinking Clinical Trials

Berman Institute of Bioethics & Johns Hopkins Bloomberg School of Public Health. If public demand for greater data sharing is to be driven by awareness of its benefits, then PCTs need to do a better job measuring and communicating about the benefits. Can you better define data sharing, is it the publication?

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Grand Rounds December 15, 2023: Diversifying Clinical Trials: A Path Forward (Roxana Mehran, MD, FACC, FAHA, MSCAI, FESC)

Rethinking Clinical Trials

Diversity in clinical trials is important for generalizability of results, to provide equal opportunities, practice precision medicine, tailor practical guidelines, improve public health outcomes, detect potential differences in safety and efficacy, and to address health disparities. We have to change how we are practicing.

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

Rethinking Clinical Trials

How will it be framed in the public discourse? When we are communicating about our science, it is important to engage with traditional media and take the time to get to know reporters who are interested in the science. AI generated work has been submitted to journals and other publications. It is important to avoid hype.

Medicine 130
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Grand Rounds March 24, 2023: From Observational Studies to Pragmatic Clinical Trials: (Almost) A Decade of Research in PCORnet® (Erin Holve, PhD, MPH, MPP; Russell Rothman, MD, MPP; Schuyler Jones, MD; Neha Pagidipati, MD, MPH)

Rethinking Clinical Trials

sites and PIs are really interested in collaborative academic partnerships.                                            Speakers Erin Holve, PhD, MPH, MPP Chief Research Infrastructure Officer, Patient-Centered Outcomes Research Institute (PCORI) Russell Rothman.

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Grand Rounds August 5, 2022: Economic Evaluation of Platform Trial Designs (Jay JH Park, PhD, MSc)

Rethinking Clinical Trials

We administered a survey to international experts with publication record on platform trials and master protocols using purposive sampling. These platform trials are almost a public good so that there is a sustainable model for the infrastructure so it continues to grow and evolve and no one bears the full cost. Discussion Themes.

Trials 130
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Patent wars: what’s behind Amgen’s possible win over Sanofi at the US Supreme Court

Pharmaceutical Technology

Both drugs come with a high price tag. This is a trade-off between the patentee and the public where the patentee gets temporary exclusivity in exchange for revealing this information, adds Contreras. This case has broader implications for pharma as an industry, which explains the interest from other businesses.

Antibody 262
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Grand Rounds November 3, 2023: The Perils and Pitfalls of Complex Clustering in Pragmatic Trials (Jonathan Moyer, PhD; Moderator: Andrea Cook, PhD)

Rethinking Clinical Trials

In this trial, the researchers were interested in three main data structures. Discussion Themes -It seems that any trial that involves an intervention that delivers the intervention through agents, people, or in a group formation you discussed that would be a large fraction of trials in public health and medicine.

Trials 130