Clinicals trials
Latest developments in the world of clinical trials in cancer
It is by now recognized by all that clinical trials play a fundamental role in establishing new treatments for all kinds of diseases. For example, in Cancer, clinico-genomic trials as proposed by ACGT are critical in providing new insights on the molecular biology of the disease, leading to more personalized medicine with higher cure rates and fewer side effects. For child populations clinico-genomic trials help promote evidence based use of drugs, given that a lot of drugs used in children today are off-label.
In recognition of the importance of clinico-genomic trials the European Community has decided to support the development of a European register of clinical trials in children as part of its Fifth Framework Programme, Thematic Programme "Quality of Life" (contract QLG4-CT-2002-01054), in 2002. The project ?The European register of clinical trials on medicines for children - Drug Evaluation in Children? (DEC-net), is co-ordinated by the Laboratory of Mother and Child Health of the "Mario Negri" Institute for Pharmacological Research in Milan and currently involves members from four countries: France, Italy, Spain, and the United Kingdom. It is unique in that it is the first population oriented clinical trial register.
The DEC-net register (www.dec-net.org) which was activated on July 1st 2004 is freely available to anyone interested in accessing information on paediatric drug therapy clinical trials. The register was set up by four groups (Italy, UK, France, Spain). A recent publication (Chiara Pandolfini et al.: The DEC-net European register of paediatric drug therapy trials: contents and context. Eur J Clin Pharmacol (2008) 64:611?617) updates the results for the years 2004 to 2006 of the registry.
Altogether only 257 trial records were analysed (86 from Italy, 84 from UK, 56 from France and 31 from Spain). Included are multinational and also single-centre trials. 46 different countries are listed as participating in the multinational trials. Those appearing most commonly, aside from the project?s member countries, were Germany (in 36 trials), Belgium (28), Sweden (19), the Netherlands (19) and Switzerland (17). Only 39 % of these trials were funded by Industry. Charities and Universities still play an important source of funding (13 %, 12 %). Interestingly the majority of the trials was experimental (79%), and most were in phase III (48%) and in phase IV (30%). A majority of the trials were randomised (62%). The most commonly represented diseases, based on ICD9 group, were neoplasms (14%).
A total of 429 drugs were involved in the trials. The treatment regimens in cancer are much more complicated and only the drug class was entered. The most frequent ATC class (anatomical main group) represented was ?antineoplastic and immunomodulating agents? (157 drugs), with 26% trials involving ≥1 drugs in this class. The most common ATC subclasses (therapeutic subgroups) were antineoplastic (117 drugs; 15% trials) and immunosuppressive agents (30; 10%) showing the importance of clinical trials in childhood cancer.
What becomes obvious according to this study is that the creation of the European Medicines Agency?s (EMEA) EudraCT database is potentially one of the most important steps in regulating clinical trials. According to the latest Paediatric Regulations information on paediatric clinical trials will have to be entered in this European database while results of clinical trials will also have to be published and made available to the public. In the end the expectation is that this process will ultimately lead to better therapies and treatment optimization in Paediatrics.
News:
The International SIOP Renal Tumour Study Group (SIOP-RTSG) held a meeting in Milan in April 2008. The Group decided on a new structure and elected Prof. Dr. Norbert Graf from Homburg/Germany as their chairman and Prof. Dr. Kathy Pritchard-Jones from London/UK as their Vice-Chairman. One topic of the meeting was dealing with possible questions that should be asked in an upcoming clinico-genomic trial for Wilm?s Tumour. It was stated that a common IT infrastructure for SIOP-RTSG is mandatory. In the upcoming SIOP meeting in Berlin ACGT will hold a workshop to demonstrate the Grid infrastructure and present the advantages of ACGT and ObTiMA for SIOP-RTSG and other study groups within SIOP.