Articles Swine

15 June 2026

Study Design Considerations for the Evaluation of Pancreatic Enzyme Replacement Therapy (PERT) Products in People with Cystic Fibrosis: An Update.

Clinical evidence update from Clinical therapeutics

Clinical Context

Peer-reviewed veterinary literature continues to shape everyday decision-making for production animal practice, especially when new evidence clarifies diagnosis, treatment selection, monitoring, or clinical outcomes.

What the Study Evaluated

A study published in Clinical therapeutics in 2026 evaluated study Design Considerations for the Evaluation of Pancreatic Enzyme Replacement Therapy (PERT) Products in People with Cystic Fibrosis: An Update..

Key Findings

In 2013, the Cystic Fibrosis Foundation (CFF) published recommendations regarding study design considerations for the evaluation of porcine derived pancreatic exocrine replacement therapy (PERT) products in people with CF and exocrine pancreatic insufficiency (EPI). The purpose of this report is to provide an updated guidance with an emphasis on the design and conduct of non-inferiority (NI) trials of non-porcine derived PERT products. A CFF PERT Working Group comprised of gastroenterologists, statisticians, and authors of the 2013 publication was established to produce an updated guidance document based on their expertise in clinical trial...

Why It Matters for Veterinary Professionals

For veterinary professionals, the practical value of this work lies in how the findings may support more structured clinical assessment, clearer monitoring, and more informed decisions for production animal practice.

Practical Interpretation

The results should be interpreted in the context of the study design, population, inclusion criteria, and clinical setting. Application in practice should consider patient-specific risk factors, available diagnostics, local standards of care, and clinician judgment.

Clinical Takeaway

Overall, the study adds useful evidence for clinicians seeking to align daily practice with current veterinary research while maintaining a balanced, case-by-case approach.

Read the full article here.

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Study Design Considerations for the Evaluation of Pancreatic Enzyme Replacement Therapy (PERT) Products in People with Cystic Fibrosis: An Update.

Clinical evidence update from Clinical therapeutics

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