August 17, 2022: Making Lasting Change in Clinical Trial Inclusion and Diversity to Be Focus of PCT Grand Rounds

Head shots of Dr. Gerald Bloomfield and Dr. Michelle KelseyIn this Friday’s PCT Grand Rounds, Dr. Gerald Bloomfield and Dr. Michelle Kelsey will present “Inclusion and Diversity in Clinical Trials: Actionable Steps to Drive Lasting Change.” The Grand Rounds session will be held on Friday, August 19, 2022, at 1:00 pm eastern.

Dr. Bloomfield is an associate professor of medicine and global health and Dr. Kelsey is an assistant professor of medicine at Duke University.

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July 20, 2022: ACTIV-6 Reaches 1 Year, Will Share Results in COVID-19 Grand Rounds

Headshot of Dr. Susanna NaggieIn this Friday’s COVID-19 Grand Rounds, Dr. Susanna Naggie of Duke University will present “ACTIV-6: One Year Later and Trial Results for Ivermectin-400 and Inhaled Fluticasone.”

ACTIV-6 is a nationwide, double-blind study evaluating the effectiveness of repurposed medications in reducing symptoms of mild to moderate COVID-19 in outpatients.

The Grand Rounds session will be held on Friday, July 22, at 1:00 pm eastern. Join the online meeting.

The NIH Pragmatic Trials Collaboratory Coordinating Center is using its popular Grand Rounds platform to share late-breaking research and promote resources in support of clinical researchers affected by the COVID-19 public health emergency. For previous COVID-19 Grand Rounds, and more news and resources related to the COVID-19 public health emergency, see the COVID-19 Resources page.

Podcast July 8, 2022: FDA Draft Guidance on Real-World Evidence (John Concato, MD, MS, MPH)

This podcast continues the discussion with Dr. John Concato as he discusses the FDA draft guidance on real-word evidence. Click on the recording below to listen to the podcast.

Want to hear more? View the full Grand Rounds presentation.

For alerts about new episodes, subscribe free on Apple Podcasts or SoundCloud. Read the transcript.

July 6, 2022: Grand Rounds to Spotlight COVID-OUT Trial of Metformin, Ivermectin, and Fluvoxamine

Headshots of Drs. Carolyn Bramante, Thomas Murray, Jared Huling
Left to right: Dr. Carolyn Bramante, Dr. Thomas Murray, Dr. Jared Huling

In this Friday’s COVID-19 Grand Rounds, Dr. Carolyn Bramante, Dr. Thomas Murray, and Dr. Jared Huling of the University of Minnesota will present “Results From the COVID-OUT Trial, a Phase-3 Trial of Outpatient Treatment for COVID-19 Using Metformin, Ivermectin, and Fluvoxamine.”

The Grand Rounds session will be held on Friday, July 8, at 1:00 pm eastern. Join the online meeting.

The NIH Pragmatic Trials Collaboratory Coordinating Center is using its popular Grand Rounds platform to share late-breaking research and promote resources in support of clinical researchers affected by the COVID-19 public health emergency. For previous COVID-19 Grand Rounds, and more news and resources related to the COVID-19 public health emergency, see the COVID-19 Resources page.

June 1, 2022: This Week’s PCT Grand Rounds Will Feature MedSafer Deprescribing Study

Head shot of Dr. Emily McDonaldIn this Friday’s PCT Grand Rounds, Dr. Emily McDonald of McGill University will present “Results of the MedSafer Study: Electronic Decision Support for Deprescribing in Hospitalized Older Adults.” The Grand Rounds session will be held on Friday, June 3, 2022, at 1:00 pm eastern.

The MedSafer study was a cluster randomized clinical trial evaluating the effects of an electronic deprescribing decision support tool on adverse drug events after hospital discharge among older adults with polypharmacy.

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May 4, 2022: n-of-1 Randomized Trials to Be Featured in PCT Grand Rounds

Headshot of Dr. Gregory MarcusIn this Friday’s PCT Grand Rounds, Dr. Gregory Marcus of the University of California, San Francisco, will present “n-of-1 Randomized Trials: CRAVE and I-STOP-AFib as Examples.” The Grand Rounds session will be held on Friday, May 6, at 1:00 pm eastern.

The CRAVE trial investigated the real-time effects of caffeine intake on atrial and ventricular ectopy. The I-STOP-AFib trial assessed the efficacy of trigger-based testing for atrial fibrillation on quality of life. Both studies used n-of-1 designs.

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April 19, 2022: PCT Grand Rounds Will Feature Clinical Trial Conducted in Retail Settings

Head shots of Dr. Dylan Steen and Dr. Sarah CouchIn this Friday’s PCT Grand Rounds, Dr. Dylan Steen and Dr. Sarah Couch of the University of Cincinnati will present “Development of a Novel Research Collaboration With the Retail Industry” The Grand Rounds session will be held on Friday, April 22, at 1:00 pm eastern.

Dr. Steen, who is also the CEO of High Enroll LLC, a research participant recruitment company, will join Dr. Couch to discuss the results of SuperWIN, a clinical trial of a dietary intervention conducted in retail settings.

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April 13, 2022: SODIUM-HF Trial Will Be Featured in This Week’s PCT Grand Rounds

Head shot of Dr. Justin EzekowitzIn this Friday’s PCT Grand Rounds, Dr. Justin Ezekowitz of University of Alberta will present “SODIUM-HF: Should Our Patients Consume Less Dietary Sodium?” The Grand Rounds session will be held on Friday, April 15, at 1:00 pm eastern.

The SODIUM-HF trial is open-label, randomized controlled trial conducted at 26 sites in Australia, Canada, Chile, Colombia, Mexico, and New Zealand to test whether reduction in dietary sodium reduces the incidence of future clinical events.

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March 31, 2022: GRACE Trial Has New Study Snapshot, Updated Ethics and Regulatory Documentation

GRACE Trial logoA downloadable study snapshot and updated ethics and regulatory documentation are now available for the GRACE trial, an NIH Pragmatic Trials Collaboratory Trial.

GRACE transitioned from the planning phase to the implementation phase in September. As part of the transition, the study team reviewed and updated the minutes of their initial consultation with the Ethics and Regulatory Core. The study is a hybrid effectiveness–implementation trial of guided relaxation and acupuncture for pain associated with chronic sickle cell disease in 3 large healthcare systems.

  • Read the updated ethics and regulatory documentation, including information about the study team’s approach to inclusion and exclusion criteria, informed consent, and collection of patient-reported outcome data.
  • Also available is a new study snapshot for GRACE. This downloadable handout summarizes the study’s aims, lessons from the planning phase, and links to other resources from this innovative pragmatic clinical trial.

GRACE is supported by the NIH through the NIH Heal Initiative under an award from the National Center for Complementary and Integrative Health. Learn more about the GRACE trial.