Ethical Considerations of Placebo controls and the Role of Historical Controls and Real-World Evidence in Clinical Trials

Reassessing the Role of Placebos in Veterinary Trials

Placebo-controlled trials have long served as a scientific standard, but their use—particularly in vulnerable populations—raises critical ethical questions. In veterinary medicine, where informed consent cannot be obtained from animal participants, the need for more humane trial designs is even more pronounced.

Evolving Standards in Clinical Research

This technical bulletin explores emerging alternatives to traditional placebo-controlled designs, including the use of single-arm trials, historical controls, and real-world evidence (RWE). These methodologies are gaining traction in both human and veterinary regulatory frameworks, particularly for rare, painful, or progressive diseases.

Highlights from the Bulletin

• Ethical concerns regarding placebo use in vulnerable populations
• The regulatory and scientific support of historical controls and RWE
• Recent FDA and EMA guidance on using real-world data for drug evaluation

Why This Matters to Gallant

As Gallant advances mesenchymal stem/stromal cell (MSC) therapies for conditions with limited treatment options, this bulletin helps contextualize our approach to clinical trial design—prioritizing both scientific integrity and ethical responsibility. By leveraging real-world data and minimizing unnecessary placebo use, Gallant supports innovation that is rigorous, humane, and regulatory-grade.

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This content is for educational purposes only and reflects Gallant’s commitment to advancing ethical and evidence-based veterinary research.