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Expanded Access Programmes (EAPs) face regulatory inconsistencies globally. Harmonizing definitions between the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) is crucial for accurate protocol classification and international study management.

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Area of Science:

  • Regulatory Science
  • Clinical Trial Management
  • Pharmaceutical Policy

Background:

  • Expanded Access Programmes (EAPs) allow therapeutic drug use outside clinical trials for life-threatening diseases.
  • Global regulations for EAPs vary, impacting patient access and study classification.
  • The European Medicines Agency (EMA) recommendation includes post-clinical trial treatment, blurring lines with Open-label Extension studies.

Purpose of the Study:

  • To analyze the origin of misclassification in Expanded Access Programmes (EAPs).
  • To compare and contrast USA, European, and Italian regulations concerning EAPs.
  • To highlight challenges in classifying international study protocols due to definition inconsistencies.

Main Methods:

  • Critical review of USA, European, and Italian regulations for EAPs.
  • Analysis of practical cases by retrieving protocols from ClinicalTrials.gov and the Italian Clinical Trials Registry (OsSC).
  • Keywords used for retrieval: 'Expanded Access Programme', 'Expanded Access', 'Open-label Extension study', 'Early Access'.

Main Results:

  • The US Food and Drug Administration (FDA) provides a clear EAP definition, unlike the EMA.
  • EMA's definition resembles that of Open-label Extension studies, leading to misclassification.
  • Observed misclassifications include EAPs with efficacy endpoints, EAPs managed as clinical trials, and incorrect registry classifications.

Conclusions:

  • Harmonization of EAP legislation and definitions globally is essential for international study management.
  • Recommendations include aligning EMA's EAP definition with the FDA's and making European regulations compulsory.
  • Establishing separate registries for EAPs and clinical trials is proposed to improve clarity.