Clinical trials in paediatric haematology-oncology: are future successes threatened by the EU directive on the conduct of clinical trials?

Mitchell, Chris
November 2007
Archives of Disease in Childhood;Nov2007, Vol. 92 Issue 11, p1024
Academic Journal
The article focuses on the clinical trials in pediatric hematology-oncology among children in Europe. It is noted that the development of therapy for Wilm's tumor is often cited as an example of the multicenter cooperative approach in conducting randomized clinical trials in rare diseases. It is noted that the neuroblastoma therapy employs three main components including induction chemotherapy, consolidation with high-dose chemotherapy, and differentiation treatment using cis-retinoic acid. It has been concluded that the academic clinical trial researchers will have to live within the constraints imposed by the European Union directive and Great Britain legislation with the opposing implications for trial costs and researcher time.


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