clinical trials

March 9, 2022: PCT Grand Rounds to Feature MIPACT Study and THRIVE Pragmatic Trial

Posted on by Damon Seils
Headshots of Dr. Sachin Kheterpal, Dr. Jessica Golbus, and Nicole Pescatore
Dr. Sachin Kheterpal, Dr. Jessica Golbus, and Nicole Pescatore

In this Friday’s PCT Grand Rounds, Dr. Sachin Kheterpal, Dr. Jessica Golbus, and Nicole Pescatore of the University of Michigan will present “Understanding a Patient’s Daily Experience Through Mobile Devices and Wearables: Lessons Learned From the 8000 Patient MIPACT Study and Implementation in a National Pragmatic Trial.” The Grand Rounds session will be held on Friday, March 11, at 1:00 pm eastern.

The Michigan Predictive Activity and Clinical Trajectories (MIPACT) study is a prospective observational study exploring whether data collected on an Apple Watch, combined with home blood pressure measurements and other health information, can provide insights into health and disease. The Trajectories of Recovery After Intravenous Propofol vs Inhaled Volatile Anesthesia (THRIVE) trial is a pragmatic trial of of intravenous vs inhalational general anesthesia in patients undergoing elective noncardiac surgery.

Join the online meeting.

February 18, 2022: Building a Resource: The Process of Developing a Trans-stakeholder Framework to Enable Pediatric Drug Development (Perdita Taylor-Zapata, MD)

Posted on by terren.green@duke.edu

Speaker

Perdita Taylor-Zapata, MD
Best Pharmaceuticals for Children Act (BPCA) Program Lead and NICHD Program Officer
Obstetric and Pediatric Pharmacology and Therapeutics Branch
National Institute of Child Health and Human Development

Keywords

NIH Best Pharmaceuticals for Children Act; Pediatric Trial Network; Trial design; Pediatric drug development

Key Points

  • The current model for pediatric drug development can be slow and neglect neonates and rare pediatric conditions.
  • The NIH Best Pharmaceuticals for Children Act (BPCA) allows the NIH to conduct clinical trials with off-patent drugs in children.
  • Goals of the BPCA program include developing novel trial designs and including diverse and understudied populations.
  • A new framework to enable pediatric drug development could identify resources to assist in drug development, identify areas in need of further research, provide a pathway for integrating approaches, and connect pediatric researchers.
  • The BPCA went through a rigorous systematic approach to develop a comprehensive resource listing for best practices for pediatric drug trials.

Discussion Themes

Most data collected through the opportunistic model presented is PK data to determine dosing so that a more traditional drug trial can be conducted in the future.

With the right infrastructure in place, such as the Pediatric Trials Network, can substantially improve time to conduct trials.

 

Read more about the BPCA and their commitment to diversity in pediatric drug trials.

 

Tags

#pctGR, @Collaboratory1

February 23, 2022: PCT Grand Rounds Will Feature Fully Remote CHIEF-HF Trial

Posted on by Damon Seils
Headshot of Dr. John Spertus
Dr. John Spertus

In this Friday’s PCT Grand Rounds, Dr. John Spertus of the University of Missouri–Kansas City will present “The Next Generation of Patient-Centered Trials – No Site Visits, Home Delivery of Meds and Patient-Reported Outcomes – The CHIEF-HF Trial.” The Grand Rounds session will be held on Friday, February 25, at 1:00 pm eastern.

The CHIEF-HF trial examined the effect of canagliflozin on symptoms and quality of life for patients with heart failure. The trial was conducted completely remotely because of the COVID-19 pandemic and thus offers lessons about remote strategies in future clinical trials.

Join the online meeting.

February 16, 2022: Pediatric Drug Development Is Focus of PCT Grand Rounds This Week

Posted on by Damon Seils
Headshot of Dr. Perdita Taylor Zapata
Dr. Perdita Taylor-Zapata

In this Friday’s PCT Grand Rounds, Dr. Perdita Taylor-Zapata of the National Institute of Child Health and Human Development (NICHD) will present “Building a Resource: The Process of Developing a Trans-Stakeholder Framework to Enable Pediatric Drug Development.” The Grand Rounds session will be held on Friday, February 18, at 1:00 pm eastern.

Dr. Taylor-Zapata, a board-certified pediatrician, leads the NICHD’s Best Pharmaceuticals for Children Act clinical program, a drug development program that sponsors clinical trials to inform and improve pediatric drug labeling.

Join the online meeting.

February 9, 2022: PCT Grand Rounds to Highlight Machine Learning in Clinical Research

Posted on by Damon Seils
Headshots of Dr. Hope Weissler and Dr. Erich Huang
Dr. Hope Weissler and Dr. Erich Huang

In this Friday’s PCT Grand Rounds, Dr. Hope Weissler of Duke University and Dr. Erich Huang of Onduo will present “Great Power and Great Responsibility: Machine Learning in Clinical Research.” The Grand Rounds session will be held on Friday, February 11, at 1:00 pm eastern.

Join the online meeting.

February 2, 2022: This Friday in PCT Grand Rounds, the SPIRRIT-HFpEF Registry-Based Randomized Clinical Trial

Posted on by Damon Seils
Headshots of Dr. Adam DeVore and Dr. Lars Lund
Dr. Adam DeVore and Dr. Lars Lund

In this Friday’s PCT Grand Rounds, Dr. Adam DeVore of Duke University and Dr. Lars Lund of the Karolinska Institutet will present “SPIRRIT-HFpEF: Opportunities and Challenges in a Large Registry-Based Randomized Clinical Trial.” The Grand Rounds session will be held on Friday, February 4, at 1:00 pm eastern.

SPIRRIT-HFpEF is using a registry-based randomized clinical trial design to determine whether initiation of spironolactone plus usual care improves outcomes of patients with heart failure with preserved ejection fraction compared with usual care alone.

Join the online meeting.

January 26, 2022: PCT Grand Rounds to Highlight Primary Results of EMBED Trial

Posted on by Damon Seils
Headshots of Dr. Edward Melnick and Dr. Gail D'Onofrio
Dr. Edward Melnick and Dr. Gail D’Onofrio, co–principal investigators of EMBED

In this Friday’s PCT Grand Rounds, the principal investigators of EMBED, an NIH Collaboratory Trial, will announce the study’s primary results.

Co–principal investigators Dr. Edward Melnick and Dr. Gail D’Onofrio of Yale University will present “EMBED Trial Results: Pragmatic Trial of User-Centered Clinical Decision Support to Implement Emergency Department-Initiated Buprenorphine for Opioid Use Disorder.” The Grand Rounds session will be held on Friday, January 28, at 1:00 pm eastern.

EMBED is a pragmatic trial to evaluate the effect of user-centered computerized clinical decision support on rates of emergency department–initiated buprenorphine and referral for ongoing medication-assisted treatment for patients with opioid use disorder.

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EMBED is supported within the NIH Collaboratory by the NIH Common Fund and by a cooperative agreement from the National Institute on Drug Abuse.

January 19, 2022: PCT Grand Rounds Will Feature PRIM-ER Study of Primary Palliative Care in Emergency Medicine

Posted on by Damon Seils
Headshot of Dr. Corita Grudzen
Dr. Corita Grudzen, principal investigator of PRIM-ER

In this Friday’s PCT Grand Rounds, the principal investigator of PRIM-ER, an NIH Collaboratory Trial, will share an update on the implementation of this innovative pragmatic clinical trial.

Principal investigator Dr. Corita Grudzen of the NYU Grossman School of Medicine will present “Primary Palliative Care for Emergency Medicine.” The Grand Rounds session will be held on Friday, January 21, at 1:00 pm eastern.

PRIM-ER, or the Primary Palliative Care for Emergency Medicine study, is a cluster randomized pragmatic trial of a multidisciplinary primary palliative care intervention that consists of education, clinical decision support, and other elements in a diverse mix of emergency departments in the United States. The intervention is intended to improve the delivery of goal-directed emergency care of older adults.

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PRIM-ER is supported within the NIH Collaboratory by a cooperative agreement from the National Institute on Aging.

January 18, 2022: Documentation Available From Ethics and Regulatory Consultation With IMPACt-LBP NIH Collaboratory Trial

Posted on by Damon Seils

NIH Pragmatic Trials Collaboratory logo

Meeting minutes and supplementary materials summarizing a recent discussion of ethics and regulatory issues associated with the new IMPACt-LBP NIH Collaboratory Trial are now available. The consultation took place by video conference and included representation from the study’s principal investigators and project manager, members of the NIH Collaboratory’s Ethics and Regulatory Core, NIH staff, and NIH Collaboratory Coordinating Center personnel.

IMPACt-LBP is a 2-arm cluster randomized trial that will evaluate the effect of first-contact patient referral to physical therapists and doctors of chiropractic for patients with low back pain. The study aims to determine if initial contact with these clinicians will improve physical function and decrease pain, among other outcomes, in patients with a primary complaint of low back pain, when compared with usual medical care. Read more about IMPACt-LBP.

Ethics and regulatory documentation for all of the NIH Collaboratory Trials is available on our Data and Resource Sharing page.

January 12, 2022: COVID-19 Grand Rounds to Address Stakeholder Perspectives in Outpatient Trials

Posted on by Damon Seils
Headshot of Dr. Christopher John Lindsell
Dr. Christopher John Lindsell

In this Friday’s COVID-19 Grand Rounds session, Christopher Lindsell of Vanderbilt University will present “Searching for A Unicorn: Understanding Stakeholder Perspectives When Selecting Outcomes for Outpatient Trials.” Lindsell will discuss lessons about choosing endpoints in outpatient COVID-19 trials.

The Grand Rounds session will be held on Friday, January 14, 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.