Quality management systems should be established that include organisational structure, responsibilities, policies and standards
The European Medicines Agency (EMA) has updated its guidance on evaluating anticancer medicinal products for humans, so that pharmaceutical firms are better able to develop and assess treatments for leukaemia.
The Agency recommends that quality management systems be established that include organisational structure, responsibilities, policies and standards.
These are needed to ensure accuracy and satisfactory quality of evaluation assays trying to establish whether cancer cells have been destroyed. All local laboratories within a clinical trial should undergo inter-laboratorial comparisons (round-robin tests) to normalise results, said the guidance, making them comparable between different laboratories and maybe between different trials. It says that a difference in remission response rates 'can be used as primary evidence of clinical benefit' to obtain early licences, where more established data will only become available at a later stage.
This EMA guidance also advises on the development of treatments for lung, prostate and blood cancer as well as stem cell transplants.