Medical treatment of echinococcosis under the guidance of Good Clinical Practice (GCP/ICH)

摘要

Chemotherapy is one of the main components for the treatment of alveolar and cystic echinococcosis. Benzimidazoles are on the market since 30 years, and are used widely according to the recommendations of the 1996 WHO guidelines for treatment of cystic and alveolar echinococcosis [Bull WHO 1996; 74: 231-242.]. However, none of the two drugs (Albendazole or Mebendazole) would satisfy today the requirements for an approval by the relevant authorities, such as the European Agency for the Evaluation of Medicinal Products (EMEA) or the Food and Drug Administration (FDA). New anthelmithic drugs are in the pipeline, and some of them have already undergone preclinical testing. In addition, recent advances have been made in the definition of outcomes for clinical trials in alveolar echinococcosis. Thus, phase III studies with new active ingredients are needed to assess short- and long-term safety as well as the therapeutic value. The basic requirements for comparative drug testing are provided in the Note for Guidance on Good Clinical Practice (GCP), and are based upon the rules and regulations by International Conference on Harmonization (ICH) and the Clinical Trial Directive (Directive 2001/20/EC) of the European Commission. The application of these standards to new drug testing for echinococcosis will help to upgrade the level of evidence.