The European Medicines Agency has published for public consultation:
- Guideline on the clinical evaluation of anticancer medicinal products
- Appendix 3 to the Guideline on the clinical evaluation of anticancer medicinal products
The purpose of this guideline is to provide guidance on all stages of clinical drug development for the treatment of malignancies, including drug resistance modifiers or normal tissue protective compounds. This 6th revision addresses the most recent designs in oncology (such as umbrella and basket trials, so-called master protocols) and the emergence of indications defined in the first place by a biomarker selective for a disease sensitive to the treatment.
Whilst the thrust of a regulatory guideline should be on confirmatory studies, the aim of this guideline is also to underline the use of exploratory studies in order to identify the most appropriate target population in addition to the usual aims: to define dose, schedule, tumour type and line of therapy. The role of biomarkers to achieve these objectives is also further emphasised in this revised guideline.
The EMA may collect and further process some personal data of stakeholders and interested parties who submit contributions to the consultations. For more information, see Specific privacy statement for public and targeted consultations.
For more information on the European regulatory system for medicines, please click here (brochure available in all languages).