Abstract 287: Trial Haven: the Ethical Risks of Offshore Mechanical Thrombectomy Trials
Authors: Nepal G. 
Published: January 2025

Introduction

Randomized controlled trials (RCTs) in low‐ and middle‐income countries (LMICs) offer significant potential for advancing global health. However, these RCTs often face conflicts between pharmaceutical industry incentives and global health priorities. The high costs, strict regulations, and extensive requirements of Phase 3 trials make LMICs more appealing than high income countries (HICs). For MT trials, LMICs offer advantages such as higher stroke rates, lower costs, more flexible regulations, shorter timelines, and a strong willingness to participate from both patients and local clinicians. However, the industry's motivations extend beyond these practical considerations. These collaborative trials present several ethical concerns, including power imbalances between industry or HICs investigators and those from LMICs, vulnerabilities of patients and clinicians in LMICs, health system unprepared for RCTs and the limited availability of interventions to locals once the RCTs are concluded. Major ethical issues include using control arms (SMT) that fall below the standard of care in HICs and inadequate post‐protocol treatment. Accepting inferior SMT and minimal post‐protocol care in LMICs hospital settings can introduce bias favoring experimental devices. Data from these RCTs, used for FDA approval, could lead to negative outcomes for patients in both LMICs and HICs. We plan to do a global mapping of current RCTs scenario in MT for acute ischemic stroke.

Methodology:

The search terms “Stroke,” “Large Vessel Occlusion,” and “Mechanical Thrombectomy” were entered into the ClinicalTrials.gov search form. Filters were then set to show only new RCTs that are either currently recruiting participants or are planning to recruit. RCTs that were completed, terminated, or had unknown statuses were excluded.

Results

Our search identified 44 ongoing RCTs across various countries. The USA leads with 14 trials (25.45%), followed by China with 13 trials (23.64%), and France with 8 trials (14.55%). Turkey and Brazil each have 3 trials (5.45%), while Spain has 2 trials (3.64%). Argentina, Canada, Germany, Hungary, India, Israel, Italy, the Netherlands, Pakistan, Paraguay, Poland, and Taiwan each have 1 trial (1.82%). In terms of funding sources, industry funded 18 trials (40.91%), the NIH funded 1 trial (2.27%), and other sources funded 25 trials (56.82%). Of the industry‐sponsored trials, 10 (55.55%) are conducted offshore, 5 (27.77%) are in the USA, and 3 (16.66%) involve both domestic and international sites.

Conclusion

Globalizing MT RCTs offers benefits but also risks if oversight is inadequate. It's crucial to ensure that trials benefit local populations and local needs. Advocacy should prioritize locally relevant, need based, investigator‐initiated stroke trials in LMICs, rather than industry‐driven “parasitic” or “parachute” RCTs that may exploit LMICs patients for drug approvals in HICs. Even non‐industry‐funded trials in LMICs can be influenced by industry interests through collaborating researchers from HICs who is getting industry benefits. Rigorous ethical oversight is essential to prevent exploitation and ensure the integrity of these trials.