Do Results of Randomized Controlled Trials Performed in High-Income Countries Translate to Low-And Middle-Income Countries?

Saturday, April 29, 2023

2:00 PM – 3:30 PM ET

Location: Convention Center: 207 A

CE: Live CME: 1.50

Selected By: SPR
Co-sponsored By: Newborn Brain Society, CNS

Chair(s)

Seetha Shankaran, MD (she/her/hers)

Neonatologist
Pediatrics
Wayne State University School of Medicine
Austin (AUS), Texas, United States
Zulfiqar Bhutta, MBBS, PhD

Co-Director
Centre for Global Child Health
The Hospital for Sick Children
The Hospital for Sick Children
Toronto, Ontario, Canada

Disclosure(s):

Seetha Shankaran, MD: I do not have any relevant financial / non-financial relationships with any proprietary interests.

Zulfiqar A. Bhutta, MBBS, PhD: I do not have any relevant financial / non-financial relationships with any proprietary interests.

Session

Description: Less than 20% of all clinical trials are conducted in low-and middle-income countries (LMICs) who often shoulder the highest childhood disease burden. This scholarly session will discuss how the design and conduct of investigator-initiated global health trials in LMICs requires a set of skills that are unique from those required to conduct research in high-income countries (HICs). Experienced global health researchers will share their personal experiences and equip participants with a framework to undertake impactful global health research.

The following global health trials will be discussed: FEAST, HELIX, ASPIRIN and PPaX. Leaders from each of these trials will illustrate best practices for global health trials by examining such topics as asking appropriate research questions, designing trials for the LMIC context, choosing a suitable primary outcome, and maintaining equipoise about results (keeping in mind that HIC randomized controlled trials [RCTs] may not translate to LMICs). Trialists will also address unique issues of executing RCTs in LMICs such as obtaining appropriate administrative/governmental approvals, training, and certifying research teams, conducting a trial protocol, and disseminating results, including the challenge of adopting effective therapies when results differ from established clinical practices. The heterogeneous effects of interventions in different populations and thus importance of studying health interventions within the context in which they will be used will be emphasized. The session will also cover the informed consent process and draw on implementation science methodologies to illustrate opportunities to engage with families, frontline workers, stakeholders, and end-users to ensure interventions are appropriate for the LMIC context.

Learning Objectives:

Frame correct research questions and design for global health trials to achieve the maximum health impact [benefit] for the low- and middle-income countries population.
Understand why research findings in high-income countries may not always translate to low- and middle-income countries.
Describe and address the challenges and ethical issues around research governance and informed consent in low- and middle-income countries

Presentations:

2:00 PM – 2:05 PM ET

Why do we need Clinical Trials in Low and Middle-income Countries?
Speaker: Seetha Shankaran, MD (she/her/hers) – Wayne State University School of Medicine
2:05 PM – 2:17 PM ET

Anatomy of the Hypothermia for Encephalopathy in Low and Middle-income Countries (HELIX) Trial
Speaker: Sudhin Thayyil, MD, FRCPCH, PhD – Imperial College London
2:17 PM – 2:29 PM ET

Anatomy of the Fluid Expansion as Supportive Therapy (FEAST) Trial
2:29 PM – 2:41 PM ET

Anatomy of the Low-dose Aspirin for Prevention of Preterm Delivery (ASPIRIN) Trial
Speaker: Melissa Bauserman, MD MPH – University of North Carolina at Chapel Hill School of Medicine
2:41 PM – 2:53 PM ET

Anatomy of the Prevention of Prematurity and Xylitol (PPaX) Trial
Speaker: Gregory C. Valentine, MD, MED, FAAP (he/him/his) – University of Washington
2:53 PM – 3:05 PM ET

How do we engage Local Stakeholders in Research in Low and Middle-income Countries?
Speaker: Jacquelyn Patterson, MD MPH – University of North Carolina at Chapel Hill School of Medicine