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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

During the COVID-19 pandemic, several regulatory authorities around the world introduced guidance on DCTs. The Food and Drug Administration (FDA) issued a draft guidance in May 2023 that provided guidance about the conduct of decentralized clinical trials. Learn more Read more about Decentralized Clinical Trials.

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June 24, 2022: FDA Draft Guidance on Real-World Evidence (John Concato, MD, MS, MPH)

Rethinking Clinical Trials

Big data; Real-word evidence; Real-world data; 21st Century Cures Act; FDA Draft Guidance. and the FDA Draft Guidance for RWD/RWE. The post June 24, 2022: FDA Draft Guidance on Real-World Evidence (John Concato, MD, MS, MPH) appeared first on Rethinking Clinical Trials. Center for Drug Evaluation and Research (CDER).

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Grand Rounds August 18, 2023: Opportunities to Improve Clinical Trials: Draft Revision of the ICH Good Clinical Practice Guideline (E6R3) (Prof Sir Martin Landray, FMedSci; M. Khair ElZarrad, PhD, MPH)

Rethinking Clinical Trials

Food and Drug Administration (FDA) Slides Keywords Pragmatic trials; Research; Guidance, Regulatory, Data Governance Key Points The clinical trial enterprise needs modernization. Unnecessary, irrelevant, or ultra-specific guidance can cause more harm than good. We encourage people to review the guidance and provide feedback.

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Grand Rounds August 18, 2023: Opportunities to Improve Clinical Trials: Draft Revision of the ICH Good Clinical Practice Guideline (E6R3) (Prof Sir Martin Landray, FMedSci; M. Khair ElZarrad, PhD, MPH; Adrian F. Hernandez, MD, MHS)

Rethinking Clinical Trials

Food and Drug Administration (FDA) Slides Keywords Pragmatic trials; Research; Guidance, Regulatory, Data Governance Key Points The clinical trial enterprise needs modernization. Unnecessary, irrelevant, or ultra-specific guidance can cause more harm than good. We encourage people to review the guidance and provide feedback.

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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

As one of the federal departments and agencies with the largest research and development budget, the NIH came out with one of the first federal data sharing policies in 2003 called the NIH Data Sharing Policy and Implementation Guidance. pctGR, @Collaboratory1.

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Grand Rounds September 22, 2023: Integrating Community Health Workers into Team-Based, Early Childhood Preventative Care (Tumaini Rucker Coker, MD, MBA)

Rethinking Clinical Trials

The American Academy of Pediatrics (AAP) Bright Futures guidelines for preventive visits include history, measurements, physical exam, developmental and behavioral screening, anticipatory guidance, and psychosocial and social needs screening and guidance. How might we better structure preventive visits?

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Google’s 2021 Title Shakeup Part 1: What Pharma Marketers Should Know

Intouch Solutions

blue links) of the organic results appeared to be pulling from content outside of the HTML title tag at a much higher frequency. Since then, Google has confirmed this change and provided additional guidance. Title Tag – This is an HTML element that provides a title for the page. Specifically, title links (i.e., Source: Google.