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ICH E11 Clinical investigation of medicinal products in the paediatric population (CPMP/ICH/2711/99)

 ICH E11, titled "Clinical Investigation of Medicinal Products in the Pediatric Population," with the reference number CPMP/ICH/2711/99, is a guideline developed by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The guideline provides recommendations and principles for conducting clinical trials involving pediatric patients to support the development and registration of medicinal products specifically intended for use in children. Here's an elaboration of ICH E11:


1. Purpose:

The primary purpose of ICH E11 is to facilitate the development of safe and effective medicinal products for pediatric patients by providing guidance on the design, conduct, and ethical considerations of clinical trials in this population.

2. Applicability:

ICH E11 is applicable to clinical trials conducted in pediatric populations across various therapeutic areas, including investigational drugs, biologics, and medical devices. It focuses on pediatric patients from birth to 18 years of age.

3. Ethical Considerations:

The guideline places a strong emphasis on the ethical conduct of pediatric clinical trials. It underscores the importance of obtaining informed consent from the parents or legal guardians and, where appropriate, assent from the pediatric subjects themselves.

4. Pediatric Development Plans:

ICH E11 recommends that sponsors develop a pediatric development plan early in the drug development process, outlining the strategy for conducting pediatric trials. The plan should consider the specific age groups and indications for which the product is intended.

5. Age-Appropriate Formulations:

The guideline highlights the need for age-appropriate formulations, such as liquid preparations or age-specific dosing forms, to ensure that the medicinal product can be safely and effectively administered to pediatric patients.

6. Extrapolation of Data:

ICH E11 discusses the concept of data extrapolation, where data from adult trials or older pediatric populations may be used to support the efficacy and safety of the product in younger age groups when scientifically justified.

7. Pediatric Study Designs:

The guideline provides recommendations on pediatric study designs, including considerations for dose selection, endpoints, and statistical approaches appropriate for pediatric trials.

8. Safety Monitoring:

ICH E11 emphasizes the importance of safety monitoring throughout the conduct of pediatric trials. It includes recommendations for adverse event reporting and assessment of safety signals.

9. Bridging Studies:

When appropriate, bridging studies may be conducted to demonstrate that the medicinal product's effects in pediatric patients are similar to those observed in adults.

10. Regulatory Considerations:

- The guideline acknowledges the role of regulatory authorities in reviewing and approving pediatric clinical trial protocols and data. It encourages early and ongoing communication with regulatory agencies.

11. Pediatric Ethics Committees:

- ICH E11 suggests that ethics committees reviewing pediatric trial protocols should include members with expertise in pediatrics or pediatric ethics.

12. Transparency and Data Sharing:

- The guideline highlights the importance of transparency in reporting pediatric clinical trial results and encourages data sharing to benefit the scientific community and pediatric patients.


In summary, ICH E11 provides guidance for the ethical and scientific conduct of clinical trials in pediatric populations. Compliance with this guideline is essential for pharmaceutical companies and investigators involved in the development of medicinal products intended for use in children, ensuring that these products are safe, effective, and appropriately dosed for pediatric patients across different age groups.

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