Grand Rounds March 6, 2026: Bringing Primary Care Clinical Trials Research Into the 21st Century: Lessons Learned and Developments From Large-Scale European Adaptive Platform Trials of Therapeutics for Acute Respiratory Infections (Christopher C. Butler, BA, MBChB, DCH, CCH, MD, FRCGP)

Speaker

Christopher C. Butler, BA, MBChB, DCH, CCH, MD, FRCGP
Associate Head for Research
Professor of Primary Care
Professorial Fellow, Trinity College
Clinical Director, Primary Care Clinical Trials Unit
University of Oxford

Keywords

Primary Care; COVID-19; Respiratory Medicine; Adaptive Platform Trials; Large-Scale Trials; Pandemic; General Practitioners

Key Points

  • Effective primary care (PC) interventions have the potential to reach a significant portion of the community and, concurrently, have a significant impact. PC is also a good vehicle for early, self-initiated interventions, which can limit illness and enhance the sustainability of health care. However, traditional clinical trials face several challenges in PC, including general practitioners’ workload crisis, opportunistic recruitment, and geographical constraints.
  • The research team sought to address these challenges by conducting adaptive platform trials (APTs) that utilized sophisticated digital methods in a PC setting. PRINCIPLE and PANORAMIC evaluated multiple COVID-19 treatments simultaneously using innovative methods like remote eligibility checks, e-consent, and direct-to-participant drug delivery. The use of APTs demonstrated that large-scale, rigorous research can be successfully conducted outside of hospitals and provide real-world evidence.
  • Next, the research team will conduct the ECRAID-Prime trial: An international community-based APT evaluating early treatments for acute respiratory infections to prevent hospitalizations and reduce societal illness duration. They are currently in the recruitment phase, having shifted from traditional site-based recruitment to a more decentralized approach.

Discussion Themes

The National Health Service (NHS) and publicly funded clinical trials units are mission-critical because they prioritize health outcomes over profit and provide a “warm base” for rapid research.

Dr. Butler noted that busy general practitioners participated because they bought into the values and the importance of the research questions, especially when administrative burdens were minimized.

March 20, 2020: Clinical Trials in the Time of COVID-19 (Susanna Naggie, MD; Adrian Hernandez, MD, MHS; Eric Perakslis, PhD)

Speakers

Susanna Naggie, MD
Associate Dean for Clinical Research Initiatives and Regulatory Affairs
Duke University School of Medicine

Adrian F. Hernandez, MD, MHS
Professor of Medicine
Vice Dean for Clinical Research
Duke University School of Medicine

Eric Perakslis, PhD
Rubenstein Fellow
Duke University

Topic

Clinical Trials in the Time of COVID-19

Keywords

Infectious disease; Coronavirus; Pandemic response; COVID-19; Population health; Clinical trials; Human subject protections; Contingency measures; Vaccine; Contact tracing

Key Points

Discussion Themes

Do you anticipate that statisticians will need to account for period effect in later analysis of data (pre/post COVID-19)?

Are there lessons learned from the last epidemics, for example H1N1 or Ebola? How can we deal with global pandemics in the future?

What about clinical trials in the elderly population, given that they are the most vulnerable to the coronavirus and may not be as good with technology as younger participants?

Would it be possible to set up a multisite telehealth-based outbreak learning health unit?

Recent news announcements are available at NIH Announces Guidance for Clinical Trials Affected by COVID-19 Emergency and NIH Shares COVID-19 Guidance and Resources for Applicants and Recipients.

Johns Hopkins University maintains a live website of Coronavirus COVID-19 Global Cases.

Tags
#pctGR, @Collaboratory1, @texhern, @snaggie1, @DukeForge, @eperakslis