Brasília – The National Health Surveillance Agency (Anvisa) has opened a public consultation on a new guideline aligned with the international ICH E20 standard, establishing principles for the use of adaptive designs in confirmatory clinical trials. The consultation, which will remain open until November 30, 2025, invites contributions from sponsors, researchers, statisticians, clinical research organizations and patient representatives.

The draft guideline defines how adaptive trials can incorporate pre-planned modifications—such as changes in sample size, treatment arms or randomization ratios—based on interim analyses of accumulated data, provided that such adjustments are specified in the study protocol before trial initiation. The document also details methodological requirements to maintain the integrity, validity and reliability of results when adaptive strategies are applied.

Although Brazil does not yet have a specific regulation for adaptive-design studies, Anvisa states that the initiative aims to provide greater flexibility while ensuring scientific rigor in the planning and execution of clinical trials. The guideline is part of the agency’s broader effort to align national standards with international best practices, facilitating innovation and improving the quality of evidence used in health technology assessments.

Source: Anvisa

Would you like a complete analysis on this? Contact us at pharmabrnews@gmail.com