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Clinical trials in children: waiting for an european decision
- Adriana Ceci (1 September 2000)
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Adriana Ceci, secretariat of clinical trials and pharmacovigilance committee - Italian Pediatric Society University of Bari - Italy
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Following the BMJ debate on clinical trials in children I will inform interested parties in order to the Italian Pediatric Clinical Trials and Pharmacovigilance Committee initiatives. The Committeee, appointed to the Italian Society of Pediatrics adressed to the EMEA the following document dated 12 april 2000. ‘The recently proposed CPMP/ICH "Note for guidance on clinical investigation of medicinal products in the pediatric population" (CPMP/ICH/2711/99) set up several statements on clinical trial good performance suggesting that their application should be encouraged in all Member States by a specific Educational Plan. Unfortunately even if the new document represent a more advanced version
in comparison with the version come into force in 1998, it clearly appears
to be unable to face some basic problems like:
This situation developed similarly both in Europe and USA, but
recently the FDA Modernization Act modified the paediatric rules in a very
important way. In particular, according to the new FDA- 111 section:
The European current situation has been deeply discussed at the European Level trough a Round Table of Experts (see the EMEA-Report on the Experts round table on the difficulties related to the use of new medicinal products in children held on 18 December1997 in London) who drafted the below listed important proposals: Review of old drugs A review should be carried out on old products to ascertain tbe availability of clinical data on the use of these products in chudren and in order to complete labelling for different categories of age. A list of medicinal products for which information is necessarv has been drawn up by the American Association of Paediatrics. Priorities need to be established and links made with the FDA and other international regulatory authorities in order to avoid duplication of the work. Clinical Trials and Pharmaceutical Formulations Requirements: A strengthening of EU legislation shouid be considered by the European Commission in order to impose requirements on pharmaceutical cornpanies to conduct paediatric studies for medicinai products that are widely used in paediatric patients or that are indicated for a very significant or life-threatening illness. The possibility of including specific waivers to these requirements and exclusivitv clauses in some cases should be considered, together with the timing for initiation and submission ofsuch studies. Incentives: -Regulatory advice and technical assistance should be made available to the industry when planning paediatric development programmes. -A period of exclusivity could be considered for orphan indications, to stimulate development of medicinal products in these areas, in line with the current draft Regulation on orphan drugs. -Support the establishment of an EU paediatric clinical research network, involving clinical pharmacologists specialised in this field and clinical paediatricians, to increase and expedite recruitment of patients and speed up clinical development through internationai multicentre clinical trials. -An allocation of public funding from the European Commission is needed to overcome financial constraints limiting the conduct of clinical trials in children. Hence, the Clinical Trials and Pharmacovigilance Committee of the Italian Paediatric Society, asks to the EMEA and to the Commission representatives to develop the appropriate procedure in order to realise the proposals underlined by the experts. In lack of an appropriate intervention the introduction of the new rules in force in USA could increase the diversity from EU and USA leading to the exclusion of the European scientific community from the most advanced clinical researches.’ July 17 2000 we received from Noel Wathion - Head of Sector regulatory affairs and Pharmacovigilance of EMEA, the following message indicating the interest and the wish to adopt more efficacious measures. This is what we are waiting for. MESSAGE Dear Colleagues, Further to my fax dated 17 May 2000, I hereby can informn you thar the issues raised in your fax have been discussed at CPMP level. The outcome of the discussion can be summarised as follows: The CPMP agreed wtth the observation made by the Italian Society of Pediatrics and endeavours as mach as possible the development of pediatric formulations for centrally authorised products. The CPMP also states that it is up to the European Commission to make the necessary legislative proposals. Please also be informed that the Note for guidance is scheduled for Step 4 at the ICH JuIy meeting in Brussels I am copying this reply also to Dr. Brunet of DG Enterprise. Yours sincerely Noel Wathion
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