Adrian Hernandez

February 23, 2026: New Podcast Episode Outlines Guidance for Monitoring in Decentralized Trials

Posted on by Sophia Ramirez

In a new episode of the NIH Collaboratory Podcast, Drs. Christopher Lindsell and Adrian Hernandez discussed the need for virtual vigilance in decentralized trials.

Listen to the podcast. For alerts about new episodes, subscribe for free on Spotify, Amazon Music, Apple Podcasts, or SoundCloud.

Decentralized trials  move research activities from a centralized location, such as a hospital, to a location that is closer to the patient, such as their home or their local pharmacy. In addition to being more convenient for participants, decentralized trials provide research teams with the opportunity to reach a broader population.

Lindsell and Hernandez co-authored a JAMA Viewpoint entitled “Ensuring Virtual Vigilance in Decentralized Clinical Trials.” They also collaborated on the recently published Living Textbook Chapter on Decentralized Pragmatic Clinical Trials. In the podcast, they explored the opportunities that decentralized trials present and the reasons why monitoring is critical to obtaining high-quality results.

“There are 4 areas we have to think of really deeply,” Lindsell said, “Do we have the right person enrolled in the study and giving us the data? Did we get them the right intervention? And are they adherent and are they following the treatment in the right way? Are they giving us the right data and are we reacting to those data in a timely and an appropriate way?”

Research teams conducting decentralized trials should take advantage of different data streams, including metadata, to characterize ongoing engagement and ensure the appropriate engagement of participants throughout a study.

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. 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.

Podcast February 18, 2026: Virtual Vigilance in Decentralized Clinical Trials (Christopher Lindsell, PhD)

Posted on by Sophia Ramirez

In this episode of the NIH Collaboratory Podcast, Drs. Christopher Lindsell and Adrian Hernandez discuss their recent publication, “Ensuring Virtual Vigilance in Decentralized Clinical Trials,” as well as the new Living Textbook Chapter on Decentralized Pragmatic Clinical Trials.

Transcript coming soon. For alerts about new episodes, subscribe for free on Spotify, Amazon Music, Apple Podcasts, or SoundCloud.

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

Posted on by Damon Seils

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.

Join the online meeting.

May 12, 2025: Clinical Trials in a New and Evolving World, in This Week’s PCT Grand Rounds

Posted on by Damon Seils

Headshots of Dr. Jeffrey Spaeder and Dr. Adrian HernandezIn this Friday’s Rethinking Clinical Trials Grand Rounds, Jeffrey Spaeder and Adrian Hernandez will present “Pivoting Clinical Trials Into a New and Evolving World.”

The Grand Rounds session will be held on Friday, May 16, 2025, at 1:00 pm eastern.

Spaeder is the chief medical and scientific officer at IQVIA. 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.

Join the online meeting.

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

Posted on by Karen Staman

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.”

July 31, 2024: Gene Editing Therapies and Population Health, in This Week’s PCT Grand Rounds

Posted on by Damon Seils

Headshot of Dr. Adrian Hernandez
Dr. Adrian Hernandez

In this Friday’s PCT Grand Rounds, Adrian Hernandez of Duke University will present “Precision Health to Population Health: Opportunities and Challenges for Gene Editing Therapies.”

The Grand Rounds session will be held on Friday, August 2, 2024, at 1:00 pm eastern.

Hernandez is a professor of medicine and vice dean in the Duke University School of Medicine and the executive director of the Duke Clinical Research Institute. He is a co–principal investigator of the NIH Pragmatic Trials Collaboratory Coordinating Center.

Join the online meeting.

July 11, 2024: PCORI Leader Discusses Challenges of Conducting Pragmatic A vs B Clinical Trials of Approved Drugs

Posted on by Damon Seils

In an interview during the NIH Pragmatic Trials Collaboratory’s 2024 Annual Steering Committee Meeting, Tracy Wang of the Patient-Centered Outcomes Research Institute (PCORI) discussed challenges of conducting A vs B pragmatic clinical trials of approved drugs in routine clinical practice. Wang joined Adrian Hernandez, co–principal investigator of the NIH Collaboratory Coordinating Center, and Pearl O’Rourke, cochair of the program’s Ethics and Regulatory Core.

“There are a couple of key challenges, the first of which is, who’s going to pay for the drug, especially if the [drugs being compared] have differential drug costs,” Wang said. “The other aspect is, how do we preserve the rigor of that comparison, [such as] the need for blinding, which is not as pragmatic in routine practice,” she said.

Most pragmatic trials, including the NIH Collaboratory Trials and those conducted through the National Patient-Centered Clinical Research Network (PCORnet), compare standard care with proposed improvements to standard care, or “A vs A-plus trials.” Trials that compare 2 alternative treatments that are in current use, or A vs B trials, are rare.

The problem of A vs B pragmatic trials was the subject of an NIH Collaboratory workshop, as well as an article from the Coordinating Center in the New England Journal of Medicine.

Wang, a cardiologist and clinical researcher, is PCORI’s chief officer for comparative clinical effectiveness research. Hernandez is a professor of medicine and the vice dean and executive director of the Duke Clinical Research Institute in the Duke University School of Medicine. Prior to her retirement, O’Rourke was the director of human research affairs at Partners HealthCare Systems in Boston and an associate professor of pediatrics at Harvard Medical School.

Access the complete meeting materials from the 2024 Annual Steering Committee Meeting.

June 25, 2024: NIH Collaboratory Leaders Discuss the Pragmatic Trials Landscape and the Future of the Program

Posted on by Damon Seils

Leaders of the NIH Pragmatic Trials Collaboratory met in Bethesda, Maryland, last month for the program’s 2024 Annual Steering Committee Meeting—an opportunity to network and hold rich discussions on key issues related to pragmatic research.

The program added 9 new trials in the past year. The Annual Steering Committee Meeting provided a collaborative space for new and seasoned NIH Collaboratory Trial investigators to share challenges and lessons learned in conducting their pragmatic trials. They shared methods for increasing patient engagement, overcoming challenges in trial implementation, and creating reusable infrastructure. Seasoned investigators also shared insights into planning for posttrial activities and transitioning to the next trial.

In an interview at the meeting, Coordinating Center co–principal investigators Adrian Hernandez, Lesley Curtis, and Kevin Weinfurt discussed the state of the program and the current pragmatic trials landscape.

“We have more trials working in rural populations,” noted Curtis. “Something that emerged [during the meeting] is the opportunity to bring the Cores together to tackle the issues we’ve been tackling, but with a focus on rural populations, which pose some unique challenges and opportunities,” she said.

The meeting featured a fireside chat, moderated by Wendy Weber, NIH program officer for the NIH Pragmatic Trials Collaboratory, where NIH Director Monica Bertagnolli and FDA Commissioner Robert Califf shared their thoughts on how pragmatic research can help address the nation’s top health priorities. Bertagnolli highlighted an opportunity to bring pragmatic research into a primary care research network that can engage more patients in research. Califf stressed the importance of implementation science and how to maximize the evidence generated from pragmatic trials.

Weber and colleague Beda Jean-Francois of the National Center for Complementary and Integrative Health discussed the future of the NIH Collaboratory program and new directions for pragmatic research.

“I’m always amazed that there is more to learn, new frontiers, new directions—doing trials in rural communities, doing trials to address maternal morbidity,” Weber said as she reflected on key takeaways from the meeting. “We heard a challenge from the NIH Director during this meeting to think about primary care settings and how the NIH Collaboratory can help do those trials and take the lessons we’ve learned into that program,” she said.

Access the complete meeting materials from the 2024 Annual Steering Committee Meeting.

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

Posted on by Damon Seils

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

Posted on by Damon Seils

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.