In this Friday’s PCT Grand Rounds, Dr. Bruce Neal of the George Institute Australia and UNSW Sydney will share findings from a clinical trial of the effect of salt substitution on cardiovascular events and death.
The Grand Rounds session will be held on Friday, September 10, at 1:00 pm eastern. Join the online meeting.
For webinar recordings and slides from previous Grand Rounds sessions, see the Grand Rounds hub.
The Living Textbook has recently published materials that explore how randomized trials can be designed to promote both internal and external validity. The new contributions, from Drs. Merrick Zwarenstein, Ahmed Al-Jaishi, and Amit Garg, explain that consideration of the trial’s intention, whether pragmatic or explanatory, is the key to designing a trial that successfully answers its primary research question. While there is a contrast between pragmatic and explanatory intentions, there is not a dichotomy. Instead, trials will vary across the spectrum of design decisions leaning toward choices that match the trial’s purpose. The PRECIS-2 tool can help investigators design their trial to align with its intention. The authors illustrate these points in a new Living Textbook section, PRECIS-2 Case Study, which contrasts the design decisions made for two trials in a renal dialysis setting.
“The purpose should be decided before embarking on designing a trial, and each element of the trial design should be aligned to the chosen purpose.”– Zwarenstein et al. 2021
Read more at:
The Good Clinical Trials Collaborative has opened a 6-week public consultation period on its draft guidance for randomized controlled trials. The consultation period will last until September 15.
Launched in June 2020 with the support of Wellcome, the Bill & Melinda Gates Foundation, and the African Academy of Sciences, the Collaborative is developing guidance “to enable and promote informative, ethical, and efficient randomized controlled clinical trials.” The purpose of the guidance is to identify the fundamental principles of randomized controlled trials and enable their application to a wide range of healthcare settings and interventions.
Through a web-based survey, the Collaborative is seeking feedback to help shape the guidance and ensure that it is applicable in all settings. Read more about the draft guidance and provide your feedback.
In this Friday’s PCT Grand Rounds, Dr. Benjamin Hibbert of the University of Ottawa Heart Institute will share findings from the DOREMI trial of milrinone vs dobutamine for the treatment of cardiogenic shock.
The Grand Rounds session will be held on Friday, August 27, at 1:00 pm eastern. Join the online meeting.
For webinar recordings and slides from previous Grand Rounds sessions, see the Grand Rounds hub.
Eric Lenze, MD
Wallace and Lucille K. Renard Professor of Psychiatry & Anesthesiology
Washington University School of Medicine, St. Louis
Fluvoxamine for Early Treatment of COVID-19: The STOP COVID Clinical Trials
COVID-19 treatment; STOP COVID; Fluvoxamine; Repurposed therapy; Decentralized clinical trial
What outcome variables should we be using in COVID-19 studies? A binary outcome measure may limit the power of the study. When possible, continuous outcomes provide more statistical power and come closer to representing real-life outcomes.
What role should primary care providers play in clinical studies?
Read more about Dr. Lenze’s work with the STOP COVID trials.
#pctGR, @Collaboratory1
In this Friday’s COVID-19 Grand Rounds session, Dr. Eric Lenze of the Washington University School of Medicine will present “Fluvoxamine for Early Treatment of COVID-19: the STOP COVID Clinical Trials.”
The Grand Rounds session will be held on Friday, August 20, 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.
Edward Mills, PhD, FRCP Professor Department of Health Research Methods, Evidence & Impact McMaster University, Canada
Early Treatment of COVID-19 with Repurposed Therapies: The TOGETHER Adaptive Platform Trial
COVID-19 treatment; Adaptive Platform Trial; Fluvoxamine; Repurposed therapies, TOGETHER Trial
With important breakthroughs on COVID treatments, should we wait until a study is completed, accepted by a journal, and published before disseminating the findings?
Final results on the of Fluvoxamine trials are not yet available, but given the data thus far, there are no major concerns about the safety and tolerability of this medication.
Read more about the TOGETHER Early Treatment of COVID Trial.
#pctGR, @Collaboratory1, @TogetherTrial
In this Friday’s COVID-19 Grand Rounds session, Dr. Davey Smith of the University of California San Diego will present “Got Anything for This Cough? Outpatient Treatment Trials in the Time of COVID.”
The Grand Rounds session will be held on Friday, August 13, 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.
A recent PCT Grand Rounds webinar and slides presenting the results from TSOS, an NIH Collaboratory Trial, are now available. TSOS was a stepped-wedge, cluster randomized pragmatic clinical trial testing the delivery of a stepped collaborative care intervention vs usual care for 635 injured patients with PTSD symptoms and comorbid conditions at 25 level I trauma centers in the United States. The results of the study were published in March in JAMA Surgery.
The TSOS Closeout Study Snapshot is also available.
TSOS is supported within the NIH Collaboratory by a cooperative agreement from the National Institute of Mental Health.
Longtime NIH Collaboratory investigator Dr. Richard Platt will serve as co–principal investigator of a new embedded pragmatic clinical trial with Dr. Xiaojuan Li as part of the IMPACT Collaboratory. The IMPACT Collaboratory announced Li and Platt as awardees of its NIH Collaboratory Trials Program for their project Co-CARE-AD, the Collaborative Care Coordination Program for Alzheimer’s Disease and Related Dementias.
The IMPACT Collaboratory’s NIH Collaboratory Trials Program is a new funding mechanism to support full-scale, embedded pragmatic clinical trials testing nonpharmacologic interventions for people living with Alzheimer disease and related dementias and their care partners that are linked to the needs of a health care system.
Co-CARE-AD will evaluate the effectiveness of the Dementia Care Consultation program to provide multicomponent care coordination and support for community-dwelling Medicare Advantage plan members. Read more about Co-CARE-AD.
The NIA IMPACT Collaboratory is supported by a grant from the National Institute on Aging.
