Remove tag medical-information
article thumbnail

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

Food and Drug Administration, FDA, Misinformation, Communication, Health Information Key Points U.S. From January to September 2023, the Foundation conducted in-depth research and held 5 listening sessions to learn how people consume and understand health information. Observation 2: Information vacuums breed misunderstanding.

article thumbnail

Grand Rounds Ethics and Regulatory Series February 10, 2023: Informing and Consenting: What Are the Goals? (P. Pearl O’Rourke, MD; David S. Wendler, PhD, MA; Miguel Vazquez, MD; P. Michael Ho, MD, PhD)

Rethinking Clinical Trials

                                           Speakers Pearl O’Rourke, MD (retired) Harvard Medical School David S. Informed consent is not the only way to inform. The study had a waiver of informed consent. The patient population and geography across sites was very different.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

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

University of Michigan Medical School. The guidance has been updated over the years, and in 2020 NIH came out with the final iteration that goes into effect in January 2023 that applies to any research funded in whole or in part by NIH to maximize data sharing through the informed consent process. Kayte Spector-Bagdady, JD, MBioethics.

article thumbnail

Smart pharmaceutical and healthcare labels: Lets trace medicines from its origin

Roots Analysis

Traditionally, text and images were printed on pharmaceutical products to convey important information. In recent years, the use of smart labels allows the developer to convey a greater amount of information about the product to the consumers, without the need for additional packaging space.

article thumbnail

Grand Rounds March 10, 2023: Estimands in Cluster-Randomized Trials: Choosing Analyses that Answer the Right Question (Brennan Kahan, PhD)

Rethinking Clinical Trials

Two estimands will differ when there is informative cluster size in a trial. Informative cluster size refers to situations in which outcomes or treatment effects differ in large clusters versus smaller clusters. The occurrence of informative cluster size has never formally been evaluated to the presenter’s knowledge.

Trials 130
article thumbnail

Grand Rounds September 8, 2023: The DEVICE Trial: An Embedded, Pragmatic Trial of Emergency Airway Management (Matthew Prekker, MD, MPH; Jonathan Casey, MD, MSc)

Rethinking Clinical Trials

The trial operated under an IRB waiver of informed consent with a patient information sheet. There was not an opportunity for informed consent in DEVICE trial, when there was not a minute to spare for a procedure that takes 2 minutes to complete. Learn more Read more in the New England Journal of Medicine.

Trials 147
article thumbnail

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

Rethinking Clinical Trials

As researchers, we are producers and consumers of the medical literature. It is important to know and understand the information landscape into which your research is going out. This will help you release information responsibly. More broadly, citations in medical journals often do not reflect the material cited.

Medicine 130