Clinical efficacy and safety: antineoplastic and immunomodulating agents
The European Medicines Agency's scientific guidelines on the clinical evaluation of antineoplastic and immunomodulating agents help medicine developers prepare marketing authorisation applications.
For a complete list of scientific guidelines currently open for consultation, see Public consultations.
Guidelines
- Evaluation of anticancer medicinal products in man - Scientific guideline
- Evaluation of anticancer medicinal products in man - addendum on paediatric oncology - Scientific guideline
- Appendix 1 to the guideline on the evaluation of anticancer medicinal products in man - methodological consideration for using progression-free survival (PFS) or disease-free survival (DFS) in confirmatory trials - Scientific guideline
- Appendix 2 to the guideline on the evaluation of anticancer medicinal products in man - the use of patient-reported outcome (PRO) measures in oncology studies - Scientific guideline
- Appendix 4 to the guideline on the evaluation of anticancer medicinal products in man - condition specific guidance - Scientific guideline
- Clinical development of medicinal products intended for the treatment of chronic primary immune thrombocytopenia - Scientific guideline
- Clinical trials with haematopoietic growth factors for the prophylaxis of infection following myelosuppressive or myeloablative therapy - Scientific guideline
- Use of minimal residue disease as an endpoint in chronic lymphocytic leukaemia studies - Scientific guideline
Reflection papers