July 15, 2025: ClinicalTrials.gov and the State of Clinical Trials, in This Week’s Rethinking Clinical Trials Grand Rounds

Headshots of Adrian Hernandez and Rebecca Sullenger
Adrian Hernandez and Rebecca Sullenger

In this Friday’s Rethinking Clinical Trials Grand Rounds, Adrian Hernandez and Rebecca Sullenger of Duke University will present “State of Clinical Trials: An Analysis of ClinicalTrials.gov.”

They will be joined by a discussion panel that will include Sara Bristol Calvert of the Clinical Trials Transformation Initiative (CTTI) and Karen Chiswell and Christopher J. Lindsell of Duke University.

The Grand Rounds session will be held on Friday, July 18, 2025, at 1:00 pm eastern.

Hernandez, who serves as co–principal investigator of the NIH Pragmatic Trials Collaboratory Coordinating Center, is a professor of medicine and vice dean in the Duke University School of Medicine and executive director of the Duke Clinical Research Institute (DCRI). Sullenger is an MD student in the Duke University School of Medicine. Calvert is director of projects at CTTI, Chiswell is a statistical scientist at the DCRI, and Lindsell is the director of data science and biostatistics at the DCRI.

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January 15, 2025: Designing for Diversity, in This Week’s PCT Grand Rounds

Headshot of Dr. Christopher Lindsell
Dr. Christopher Lindsell

In this Friday’s PCT Grand Rounds, Chris Lindsell of Duke University will present “Design for Diversity.”

The Grand Rounds session will be held on Friday, January 17, 2025, at 1:00 pm eastern.

Lindsell is professor and cochief of biostatistics and bioinformatics, director of data science and biostatistics at the Duke Clinical Research Institute, and director of biostatistics and bioinformatics at the Duke Clinical and Translational Science Institute—all at Duke University.

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November 21, 2024: JAMA Commentary Highlights Need for Virtual Vigilance in Decentralized Clinical Trials

Headshots of Dr. Adrian Hernandez and Dr. Chris Lindsell
(Left to right) Authors Adrian Hernandez and Chris Lindsell

In a JAMA Viewpoint published online this week, coauthors Adrian Hernandez and Chris Lindsell caution that, although the use of decentralized trials creates meaningful efficiencies, there are major threats to the validity of these trials not captured by traditional monitoring and oversight practices.

In a decentralized clinical trial, some or all of the trial-related activities take place at locations other than the trial site, which can result in decrease in travel, time, and burden for patients. However, these trials can pose risks related to:

  • verifying participant identity
  • delivering the investigational product to the participant
  • minimizing lags between participants’ data entry and identification of the need for action to ensure safety and compliance, including adherence to treatment and outcome measurements

“With these risks to integrity forefront, and consistent with the principles of using decentralized elements and risk-proportionate monitoring, we propose [decentralized trials] frame their monitoring and oversight to ensure the right patient receives the right intervention, contributes the right data, and that the right response occurs for adverse events or noncompliance,” the authors wrote.

Read the full article.

This work was based on the February 23, 2024, session of the NIH Pragmatic Trials Collaboratory’s Rethinking Clinical Trials Grand Rounds webinar, “Virtual Vigilance: Monitoring of Decentralized Clinical Trials.”

February 21, 2024: In This Week’s PCT Grand Rounds, Virtual Monitoring in Decentralized Clinical Trials

In this Friday’s PCT Grand Rounds, Adrian Hernandez and Christopher Lindsell of Duke University will present “Virtual Vigilance: Monitoring of Decentralized Clinical Trials.”

The Grand Rounds session will be held on Friday, February 23, 2024, at 1:00 pm eastern.

Hernandez is the executive director of the Duke Clinical Research Institute (DCRI) and professor of medicine and vice dean in the Duke University School of Medicine. He also serves as co-principal investigator of the NIH Pragmatic Trials Collaboratory Coordinating Center. Lindsell is the director of data science and biostatistics at the DCRI and professor and cochief of biostatistics in the Department of Biostatistics and Bioinformatics in the Duke University School of Medicine.

Join the online meeting.

February 19, 2024: Virtual Monitoring in Decentralized Trials, in This Week’s PCT Grand Rounds

In this Friday’s PCT Grand Rounds, Adrian Hernandez and Christopher Lindsell of Duke University will present “Virtual Vigilance: Monitoring of Decentralized Clinical Trials.”

The Grand Rounds session will be held on Friday, February 23, 2024, at 1:00 pm eastern.

Hernandez is the executive director of the Duke Clinical Research Institute (DCRI) and professor of medicine and vice dean in the Duke University School of Medicine. He also serves as co-principal investigator of the NIH Pragmatic Trials Collaboratory Coordinating Center. Lindsell is the director of data science and biostatistics at the DCRI and professor and cochief of biostatistics in the Department of Biostatistics and Bioinformatics in the Duke University School of Medicine.

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January 27, 2022: Grand Rounds Podcast Now Available, Featuring Dr. Chris Lindsell on Selecting Outcomes for Outpatient Trials

Headshot of Dr. Christopher John LindsellIn the latest episode of the NIH Collaboratory Grand Rounds podcast, Dr. Christopher Lindsell and Dr. Adrian Hernandez continue the discussion about research outcomes and the importance of understanding stakeholder perspectives in choosing the correct outcomes for outpatient trials.

The full January 14 Grand Rounds webinar with Dr. Lindsell is also available.

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

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.

Grand Rounds January 14: Searching for a Unicorn: Understanding Stakeholder Perspectives When Selecting Outcomes for Outpatient Trials

Speaker:
Christopher Lindsell, PhD
Professor of Biostatistics and Biomedical Informatics
Director, Vanderbilt Institute for Clinical and Translational Research (VICTR) Methods Program
Codirector, Vanderbilt Health Data Science (HEADS) Center

Topic: Searching for A Unicorn: Understanding Stakeholder Perspectives When Selecting Outcomes for Outpatient Trials

Date: Friday, January 14, 2022, 1:00-2:00 p.m. ET

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