Implementation of the e5 guideline status and next steps
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Implementation of the E5 Guideline: Status and Next Steps. ICH and GCG. International leadership role in scientific harmonization Requirements for drug development must have a scientific basis Value of harmonization of regulations Brings innovative medicines to patients faster

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Ich and gcg
ICH and GCG

  • International leadership role in scientific harmonization

  • Requirements for drug development must have a scientific basis

  • Value of harmonization of regulations

    • Brings innovative medicines to patients faster

    • Reduces delays in drug development

    • Minimizes duplication of clinical studies

  • GCG: Outreach to non-ICH countries

    • ICH can add value in non-ICH countries

    • ICH is recognizing this value by expanding its activities


E5

  • Prospective harmonization to:

    • Reduce duplicative clinical testing

    • Minimize delays in drug development

  • Aimed at facilitating registration of ‘legacy’ medicines in ICH regions

  • Implementation is complex!

  • Focus today must be relevance of E5 to public health and global drug development


E5 and global development
E5 and Global Development

  • Large, multi-center, multi-ethnic clinical development programs

  • Inter- individual > inter-ethnic differences

  • Data extrapolation often possible

    • Bridging studies conducted less frequently

  • Harmonized E5 implementation is critical


E5 principles
E5 Principles

  • 3 ethnic groups– Asian, Black, Caucasian

    • Country-specific studies are not scientifically justified

  • Internationally accepted approach is critical

    • Scientific methodology

    • Regulatory process

  • Bridging studies should only be conducted if scientifically necessary


E5 criteria
E5 Criteria

  • Steps in assessing the need for bridging

    • Can the existing data be extrapolated to the new population?

    • If not, are the differences that exist clinically relevant?

    • If they are, what study is required to allow the data to be extrapolated? This is the bridging study

  • Steps 1 and 2 are ‘bridging justification’


E5 implementation
E5 Implementation

  • Must not cause disharmony among regulators

  • Requires

    • Sound science-based assessment of Clinical Data Package and relevance to new region (‘bridging justification’)

    • Well-defined regulatory process

  • Statistics has a role, but must consider

    • Statistical significance vs significance to patients and public policy

    • Questions that need to be answered before statistics are used

  • Clinical relevance is key


Regulatory environment
Regulatory Environment

  • Support innovation and public health

  • Science based

    • internationally harmonized scientific standards

  • Well-structured, consistent and transparent

    • E5 – early binding consultations

    • External advisory committee for appeals during approval process


Next steps
Next Steps

  • ICH is addressing implementation issues in a Q&A

  • Continued dialogue between regulators and industry is critical

    • At all levels: company-national regulator; industry-national regulator; industry-regulator across countries

  • Global drug development will eventually obviate the E5 guideline

    • We must continue to address E5 implementation

    • At the same time, we must start to address issues of global drug development

  • We all have a public health responsibility to support harmonization


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