Grand Rounds January 15: How CTTI & the Clinical Trials Community Have Risen to Meet the Challenge of the COVID-19 Pandemic

Speaker:

Pamela Tenaerts, MD, MBA
Executive Director
Clinical Trials Transformation Initiative

Topic: How CTTI & the Clinical Trials Community Have Risen to Meet the Challenge of the COVID-19 Pandemic
Date: Friday, January 15, 2021, 1:00-2:00 p.m. ET

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Grand Rounds January 29: The COVID-19 Citizen Science Study

Speaker:

Gregory M. Marcus, MD, MAS
Professor of Medicine
University of California, San Francisco

Topic: The COVID-19 Citizen Science Study
Date: Friday, January 29, 2021, 1:00-2:00 p.m. ET

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January 6, 2021: NIH Collaboratory COVID-19 Grand Rounds Continues With HERO-TOGETHER Long-Term Safety Study

Dr. Emily O'BrienIn this week’s COVID-19 Grand Rounds session, Dr. Emily O’Brien of Duke University will present “HERO-Together: Building Vaccine Confidence With Long-Term Outcomes Data.” The Grand Rounds session will be held on Friday, January 8, at 1:00 pm eastern. Join the online meeting.

HERO-Together is a long-term safety study of the COVID-19 vaccine developed by Pfizer and BioNTech. In the study, the Duke Clinical Research Institute (DCRI) and Verily, with funding from Pfizer, are using the HERO Registry to gain long-term insights about the vaccine by following vaccinated healthcare workers for 2 years to assess their experiences after receiving the vaccine.

The NIH 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.

Grand Rounds January 8: HERO-Together: Building Vaccine Confidence With Long-Term Outcomes Data

Speaker:

Emily O’Brien, PhD, FAHA
Associate Professor
Duke Clinical Research Institute
Duke University School of Medicine
Department of Population Health Sciences

Topic: HERO-Together: Building Vaccine Confidence With Long-Term Outcomes Data
Date: Friday, January 8, 2021, 1:00-2:00 p.m. ET

Meeting Info: To check whether you have the appropriate players installed for UCF (Universal Communications Format) rich media files, go to https://dukemed.webex.com/dukemed/systemdiagnosis.php.

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December 14, 2020: IMPACT Collaboratory Receives Grant to Monitor Adverse Events in Nursing Homes After COVID-19 Vaccination

Logo for the NIA IMPACT CollaboratoryLongtime NIH Collaboratory researcher Dr. Vincent Mor will lead a study to identify adverse health impacts among elderly nursing home residents following COVID-19 vaccination. The study is supported by a supplemental award from the National Institute on Aging to the NIA IMPACT Collaboratory. It will be used to design an adverse event monitoring system in collaboration with Genesis HealthCare, a post-acute care provider organization with more than 350 facilities in 25 states. Read more about the award.

Dr. Mor was a co–principal investigator of the Pragmatic Trial of Video Education in Nursing Homes (PROVEN), an NIH Collaboratory Trial. He also serves as a principal investigator of the IMPACT Collaboratory.

The NIA IMPACT Collaboratory is supported by a grant from the National Institute on Aging. Its mission is to advance care for persons with dementia and their caregivers in real-world settings by building national capacity to conduct pragmatic clinical trials that test interventions embedded in healthcare systems.

November 16, 2020: Grand Rounds Podcast With David Boulware on Virtual Trials in a Pandemic is Available

In the latest episode of the NIH Collaboratory Grand Rounds podcast, Dr. Adrian Hernandez and Dr. David Boulware continue the discussion of the complexities of conducting virtual clinical trials during the COVID-19 pandemic. The full October 30 Grand Rounds webinar with Dr. Boulware is also available.

Podcast November 6, 2020: Lessons from Virtual Trials in Time of a Pandemic (David Boulware, MD, MPH)

This episode of the NIH Collaboratory Grand Rounds podcast follows the conversation between Dr. David Boulware and Dr. Adrian Hernandez as they discuss the complexities of conducting virtual clinical trials during the COVID-19 pandemic.

Click on the recording below to listen to the podcast.

 

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Read the transcript.

October 30, 2020: Lessons from Virtual Trials in Time of a Pandemic: Minnesota Hydroxychloroquine Experience (David Boulware, MD, MPH)

Speaker

David R. Boulware MD, MPH
Professor of Medicine
Infectious Disease & International Medicine
Department of Medicine
University of Minnesota

Topic

Lessons from Virtual Trials in Time of a Pandemic: Minnesota Hydroxychloroquine Experience

Keywords

COVID-19; Patient-reported outcomes (PROs); Hydroxychloroquine; Epidemiology; Virtual trials

Key Points

  • These virtual randomized controlled trials evaluated hydroxychloroquine as a post-exposure prophylaxis, pre-emptive early treatment, and pre-exposure prophylaxis for COVID-19.
  • The trial of post-exposure prophylaxis employed patient-reported outcomes around COVID-19 symptoms and severity as well as side effects of hydroxychloroquine.
  • Enrollment and screening of eligible participants was automated through a REDCap survey.

Discussion Themes

Being a virtual trial, were there concerns about practicing medicine “across state lines?”

There has been a mix of science and politics over the course of the COVID-19 pandemic. Because your trial had substantial media coverage, how did the publicity affect enrollment?

Many big strategy questions can be studied virtually. What changes do you see for trials during future pandemics?

Read reports of these virtual trials in New England Journal of Medicine, Annals of Internal Medicine, and the medRxiv preprint server.

Tags

#pctGR, @Collaboratory1

October 28, 2020: NIH Collaboratory COVID-19 Grand Rounds Continues With the Minnesota Hydroxychloroquine Experience

Photo of Dr. David BoulwareIn this week’s COVID-19 Grand Rounds session, Dr. David Boulware of the University of Minnesota will present “Lessons From Virtual Trials in the Time of a Pandemic: Minnesota Hydroxychloroquine Experience.” The Grand Rounds session will be held on Friday, October 30, at 1:00 pm eastern. Join the online meeting.

The NIH 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.

 

October 22, 2020: TSOS Study Team Describes Impacts of a COVID-19 Surge on Delivery of Acute Care and Emergency Services

Photo of Dr. Doug Zatzick
Dr. Doug Zatzick, principal investigator of TSOS

A team of frontline healthcare workers in a level I trauma center recorded observations and summaries of conversations with other healthcare workers and patients about the impacts of a local surge in COVID-19 cases on care delivery.

The ethnographic study at Seattle’s Harborview Medical Center identified impacts in 4 thematic areas, including impacts on procedures, providers, patients, and quality of care. The study also identified strategies healthcare workers used to cope with the physical and mental health demands associated with the pandemic.

The article, published this week in BMJ Open, offers lessons for healthcare systems responding to the COVID-19 pandemic in other settings.

Team members recorded their observations in the context of an ongoing comparative effectiveness trial of multidisciplinary, peer-integrated care coordination for patients with severe injury, and of the ongoing Trauma Survivors Outcomes and Support (TSOS) study. TSOS, an NIH Collaboratory Trial, is a stepped-wedge, cluster randomized pragmatic trial testing the delivery of screening and intervention strategies for patients with posttraumatic stress disorder and comorbid conditions at 24 level I trauma centers in the United States.

This work was supported in part by the Patient-Centered Outcomes Research Institute (PCORI). TSOS is supported within the NIH Collaboratory by a cooperative agreement from the National Institute of Mental Health and by the NIH Common Fund through a cooperative agreement from the Office of Strategic Coordination within the Office of the NIH Director.

For more news and resources related to the COVID-19 public health emergency, see the COVID-19 Resources page.