COVID-19

Grand Rounds August 6: The TOGETHER Early Treatment of COVID Trial: Building Platform Trial Infrastructure for Infectious Diseases

Speaker:

Edward Mills, PhD, FRCP
Professor
Department of Health Research Methods, Evidence & Impact
McMaster University, Canada

Topic: The TOGETHER Early Treatment of COVID Trial: Building Platform Trial Infrastructure for Infectious Diseases
Date: Friday, August 6, 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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Meeting Number: 120 909 9614
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July 19, 2021: COVID-19 Grand Rounds Will Feature Survivor Corps and the Use of Real-World Evidence From Citizen-Scientists

Posted on by Damon Seils

Survivor Corp logo

In this Friday’s COVID-19 Grand Rounds session, Diana Berrent, Natalie Lambert, and Nick Guthe of Survivor Corps will present “Long Term COVID Patient Engagement: Best Practices Informed By Patients’ Experiences Seeking Medical Care.” The Grand Rounds session will be held on Friday, July 23, at 1:00 pm eastern. Join the online meeting.

Survivor Corps is an online community of 170,000 patients affected by COVID-19 and their families and friends. The advocacy group is using its members’ collective experience to build a repository of data sets and research tools to support COVID-19 research, including studies of post-COVID conditions, or “long COVID.” The group seeks to fill the gap between real-world evidence and scientific research to advance understanding of the disease and patients’ healthcare options.

“We have been sort of the canary in the COVID coal mine from the beginning,” said Berrent, who founded Survivor Corps in March 2020 after becoming one of the first people in the United States to be diagnosed with COVID-19.

Berrent will be joined during Grand Rounds by Survivor Corps research director Dr. Natalie Lambert and by Nick Guthe, a Survivor Corps member and adviser.

Survivor Corps’s website, which has been selected by the US Library of Congress for inclusion in the nation’s Coronavirus Web Archive, serves as a hub to provide support, information, and education about COVID-19, connect patients to researchers, and facilitate the nation’s COVID-19 response.

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 July 23: Long Term COVID Patient Engagement: Best Practices Informed By Patients’ Experiences Seeking Medical Care

Speakers:
Diana Berrent, JD
Survivor Corps, Founder

Natalie Lambert, PhD
Associate Research Professor
Indiana University School of Medicine

Nick Guthe
Survivor Corps Member and Advisor

 

Topic: Long Term COVID Patient Engagement: Best Practices Informed By Patients’ Experiences Seeking Medical Care
Date: Friday, July 23, 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.

To join the online meeting:
Go to https://dukemed.webex.com/dukemed/j.php?MTID=m228b52a4666c1e24046e11c01ae7bd0d

You must log in to the URL first.
Click ‘Audio Conference’
Choose ‘I will call in’, select the Toll number.
Dial in using the information from the dialog box that appears.
Be certain to use the Access Code AND the Attendee ID.

Troubleshooting:
If the URL above does not work, go to dukemed.webex.com and enter:
Meeting Number: 120 909 9614
Meeting Password: 1234

For Audio ONLY:
Call-in toll number (US/Canada): 1-650-479-3207
Access code: 120 909 9614

NOTE: For Toll-free users, the call-back (call me) services are also available.

July 9, 2021: COVID-19 Vaccine Efficacy Studies: Challenges and Successes (Hana El Sahly, MD)

Posted on by Gina Uhlenbrauck

Speaker

Hana El Sahly, MD
Professor of Molecular Virology and Microbiology
Baylor College of Medicine

Topic

COVID-19 Vaccine Efficacy Studies: Challenges and Successes

Keywords

COVID-19; Vaccines; Clinical endpoints; Phase 3 trials

Key Points

  • The design of Phase 3 clinical trials varies—from individual randomized clinical trials (RCTs) within sites, multiple arm trials within sites, parallel cluster RCTs, and stepped-wedge cluster RCTs—and each design produces different efficiencies and potential for evaluating the vaccine’s effectiveness.
  • The primary endpoints of vaccine trials are infection, disease, and severe disease; however, a study with a primary endpoint that captures all the endpoints of public health importance is likely not feasible.
  • A principle of clinical trials is that the study population should represent the vaccine target population. Yet, clinical trial participants traditionally are predominantly Caucasian, whereas COVID-19 disproportionately affects minorities, including a higher incidence and higher mortality.

Discussion Themes

Conducting effectiveness studies is essential to understanding how vaccines affect severe disease.

What are the arguments for or against human challenge trials?

Based on your experience during the past year, and the success of the COVID-19 vaccine trials, what applications do you see for future viruses outside a pandemic?

While some successes have been achieved, we do not know everything yet; it will be important to study other pathogens on other platforms to find approaches that ensure reliability.

Read more about Operation Warp Speed, a federal collaboration that has supported the acceleration of testing, supply, development, and distribution of COVID-19 vaccines, therapeutics, and diagnostics.

Tags

#pctGR, @Collaboratory1

July 7, 2021: COVID-19 Grand Rounds Continues With Vaccine Efficacy Studies

Posted on by Damon Seils

Headshot of Dr. Hana El Sahly
Dr. Hana El Sahly

In this Friday’s COVID-19 Grand Rounds session, Dr. Hana El Sahly of the Baylor College of Medicine will present “COVID-19 Vaccine Efficacy Studies: Challenges and Successes.” The Grand Rounds session will be held on Friday, July 9, 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.

Grand Rounds July 9: COVID-19 Vaccine Efficacy Studies: Challenges and Successes

Speaker:

Hana El Sahly, MD
Professor of Molecular Virology and Microbiology
Baylor College of Medicine
Houston, TX

Topic: COVID-19 Vaccine Efficacy Studies: Challenges and Successes
Date: Friday, July 9, 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.

To join the online meeting:
Go to https://dukemed.webex.com/dukemed/j.php?MTID=m228b52a4666c1e24046e11c01ae7bd0d

You must log in to the URL first.
Click ‘Audio Conference’
Choose ‘I will call in’, select the Toll number.
Dial in using the information from the dialog box that appears.
Be certain to use the Access Code AND the Attendee ID.

Troubleshooting:
If the URL above does not work, go to dukemed.webex.com and enter:
Meeting Number: 120 909 9614
Meeting Password: 1234

For Audio ONLY:
Call-in toll number (US/Canada): 1-650-479-3207
Access code: 120 909 9614

NOTE: For Toll-free users, the call-back (call me) services are also available.

June 3, 2021: Town Hall Will Introduce ACTIV-6 Study to Potential Sites and Investigators

Posted on by Damon Seils

Leaders of the ACTIV-6 study, featured recently during NIH Collaboratory Grand Rounds, will hold a town hall Wednesday, June 9, to share information about the study with interested stakeholders, including sites and investigators that may want to participate. The leadership team will describe the rationale for ACTIV-6, share an overview of the platform and objectives, and provide information about how to join and contribute to the study.

Contact DCRI-ACTIV6@dm.duke.edu if you would to receive a calendar invitation the event. The town hall will be recorded for those who are unable to attend.

ACTIV-6, part of the NIH’s Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) program, is a platform trial that will test whether several already approved medications can be repurposed for treating symptoms of mild to moderate COVID-19 in nonhospitalized patients.

View the April 30 Grand Rounds webinar.

June 3, 2021: Grand Rounds Podcast with Dr. Megan Ranney is Available

Posted on by Gina Uhlenbrauck

Dr. Megan RanneyIn the latest episode of the NIH Collaboratory Grand Rounds podcast, Dr. Megan Ranney and Dr. Adrian Hernandez continue the discussion about using digital technologies in clinical trials and best practices for online participant recruitment. The full May 7 Grand Rounds webinar with Dr. Ranney is also available.

May 21, 2021: The PRINCIPLE Adaptive Platform Trial for Community Treatment of COVID-19: Innovation in Trial Design and Delivery (Chris Butler, MD; Ben Saville, PhD)

Posted on by Damon Seils

Speakers

Chris Butler, MD
Nuffield Department of Primary Care Health Sciences
University of Oxford

Ben Saville, PhD
Berry Consultants

Topic

The PRINCIPLE Adaptive Platform Trial for Community Treatment of COVID-19: Innovation in Trial Design and Delivery

Keywords

COVID-19; Adaptive platform trial; PRINCIPLE; Master protocols; Direct-to-participant trial; Repurposed drugs

Key Points

  • Adaptive platform trials focus on a specific disease, asking: What is the best treatment for a unique patient with this disease? Such trials involve making adaptations to accruing data and conducting frequent interim analyses. Multiple interventions can be evaluated at the same time, and study arms can be staggered.

  • An adaptive platform is well suited to studying COVID-19 interventions. The PRINCIPLE trial aims to evaluate whether repurposed drugs can make a difference with early intervention for patients with COVID-19 symptoms. It is a nationwide (UK) clinical study from the University of Oxford to find treatments for recovery at home.

  • Adaptive platform trials have the potential to evaluate treatments quickly (to determine early superiority or futility) and the flexibility to add or remove treatments during the ongoing study. The use of “response adaptive randomization” allocates more patients to interventions having better outcomes.

  • Because most people with COVID-19 are managed in the community, community treatments may have the widest reach and impact. PRINCIPLE takes “research to the patient,” with online consent, study materials that are sent directly to patients, and patient self-sampling. Participation in the trial is not limited to where people receive healthcare.

Discussion Themes

The “inverse research participation law” (proposed by Julian Tudor Hart) posits that access to research is often inversely proportional to a participant’s potential contribution and to where the research findings should be most applicable.

A pragmatic trial should ensure that the comparator group is as close to usual care as possible. So while the trial design does not allow an understanding of the mechanisms behind any observed effect, it is the best design to find out what would happen if the treatment were used in the real world.

The PRINCIPLE study team was able to do intensive remote monitoring of patients online, by telephone, trial partner, or using routinely collected data.

Read more about PRINCIPLE and adaptive platform trials.

Tags

#pctGR, @Collaboratory1

May 18, 2021: COVID-19 Grand Rounds Continues Friday With the PRINCIPLE Adaptive Platform Trial

Posted on by Damon Seils

Photographs of Dr. Chris Butler (left) and Dr. Ben Saville (right)
Dr. Chris Butler (left) and Dr. Ben Saville (right)

In this Friday’s COVID-19 Grand Rounds session, Dr. Chris Butler of Oxford University and Dr. Ben Saville of Berry Consultants will present “The PRINCIPLE Adaptive Platform Trial for Community Treatment of COVID-19: Innovation in Trial Design and Delivery.” The Grand Rounds session will be held on Friday, May 21, 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.