Overcoming cancer with research Vienna 15 th -17 th May, Session 3: Established therapeutic compounds

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1 Overcoming cancer with research Vienna 15 th -17 th May, 2008 Session 3: Established therapeutic compounds

2 Introduction Randomized clinical trials: bedrock of progress in children with cancer in the last 40 years; More than 75% of newly diagnosed children with cancer can expect to be cured ( still using mostly established compounds!!); There is measurable variation in overall survival between regions, particularly between Eastern Europe and other countries

3 Key issues for established treatment modalities The use of off-label drug; The lack of harmonization across the EU countries of the EU Clinical Trails Directive; The add-on costs for running clinical trials ( additional diagnostic tests, drug costs, insurance, data managing, pharmacovigilance ); Harmonize the voice of pediatric oncology?

4 The use of off-label drug Most cytotoxic medicines are used outside of their licensed indications, as there are often no approvals in place for use in children; In the most recent European Guidance on Investigational Medicinal Products (IMPs) published in 2007, no mention was made of the special case of children enrolled in clinical trials, where what could be considered background of treatment often includes drugs used for an unauthorized indication.

5 The lack of harmonization across the EU countries of the CTD Definition of an interventional clinical trial: There are national inconsistencies in the inclusion of some trials under the interventional clinical trial definition to which the EU CTD applies. Treatment strategies with established compounds and linked to clinical data collection constitute research? Would it be possible for single arm studies that simply collect information on the use of a standardised current consensus best practice treatment and outcome data to avoid the full requirements of the EU CTD, e.g. need for sponsor, insurance, SAE reporting?

6 The lack of harmonization across the EU countries of the CTD Sponsorship The need for a sponsor for a clinical research trial is clear. However, it is proving very difficult for many trial groups to find a sponsor due to the wide scope of the written responsibilities. How the sponsor s responsibilities can be assumed for a multinational trial designed and overseen by a clinical trial collaborative group of academic clinicians working across different national health care structures?

7 The lack of harmonization across the EU countries of the CTD Insurance/indemnity In some countries, no additional insurance is required for patients taking part in clinical trials sponsored within the infrastructure of the NHS; other countries require specific insurance policies for patients participating in clinical trials. Is insurance really necessary for single arm best practice guidelines with associated data collection? Guidance is needed on calculation of risk and recommendations for a consistent approach to costs.

8 Conclusions Action is required now to support continuation of clinical trials networks that function well Adequate funding to support the infrastructure for academic clinical trials with appropriate training is essential We need to promote a consortium of the different existing European Pediatric Oncology networks to speak as a single voice : advise on the implementation of the EU Clinical Trials Directive especially for European/international studies; Develop and promote the use of a common platform for carrying out paediatric investigation plans Lobby for financial support. Children with cancer deserve to be given the best treatment which means routine access to well supported clinical trials coordinated through national and/or european networks.

9 Survival of children with cancer shows continued improvement but less so in Eastern Europe, where entry into clinical trials is less common West East Years since diagnosis Survival curves for cancer patients diagnosed at age 0-14 in Europe The ACCIS project (funded by EU & IARC)

10 Introduction Children s cancer specialists have a long history of collaboration in clinical and biological research projects. Collaboration between centres and between countries is essential due to: Rarity of individual cancers, therefore, Large numbers are needed for comparisons: e.g. improvement of survival from 60% to 70% requires: 1,000 patients in a clinical trial

11 Feasibility of a clinical trial requiring 1,000 patients: For childhood leukemia (a common cancer) this needs a minimum of 5 years recruitment in the average EU country of 60 million people For all other childhood cancers, national studies would require yrs recruitment: Unworkable!

12 Sponsorship: specific issues to be clarified Relation between the sponsor s responsibilities and those of the clinician. Responsibilities of clinical trial collaborative groups, which are simply networks of clinicians whose consensus views underlies protocol design, but who do not necessarily represent a legal body. Clarification for multinational trials for a single European sponsor as compared to a coordinating sponsor with national sponsors, which is a structure already used in some trials and accepted in several countries. What is legally binding, especially responsibility across national boundaries and outside of the EU, for the national sponsor and coordinating sponsor, respectively? Is the sponsor required to provide free drug if it is part of what is regarded as standard treatment regardless of whether the patient is in a clinical trial?

13 The problems Most countries do not have national data centres Very little government funding to support infrastructure for clinical trials with appropriate monitoring Difficulties obtaining sponsor and liability insurance for academic clinical trials Lack of clarity about how the national implementation of the EU Clinical Trials Directive will take into consideration academic clinical trials (usually testing established drugs without a paediatric licence which have no commercial sponsor) Strict interpretation of the Directive would lead to closure of many trials and restriction of future research portfolio, to the detriment of children with cancer in Europe and worldwide.(c.mitchell Arch Dis Child 2007; 92 (11): )

14 Potential solutions Entry into clinical trials is seen as standard of care for children with cancer in many European countries & is associated with better survival Well functioning clinical trial networks already exist in Europe Childhood cancer is the ideal platform on which to test the proposed paediatric investigation plans in the new Regulation on Medicines for Children. SIOP Europe has the organisation to assist.

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