Working Group 4: Guidelines for clinical trials and regulatory aspects

Leader: Maria Eugenia RIVEIRO

This WG will be devoted to the necessary steps to foster the translation of the developed nanomedicine cancer drug to bed/market. Specifically:

  1. Guidelines and documents describing in details the objectives, protocol design, methodology, statistical consideration and organization of eventual early clinical trials in oncology of the selected nanotechnology will be prepared.
  2. Challenges in nanomedicines regulatory science will be tackled by solving prototypical translational issues: like fostering a suitability dose scaling technique for estimation of clinical first-in-man dosed from preclinical data for nanotechnology cancer drugs, validation of adequate preclinical and toxicologic models and a deeper understanding of the PK/PD relationship will allow an adequate drug positioning in oncology targeting a relevant disease stage and disease evolution conditions, within the current setting to address appropriate personalized medicine questions.
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