Van_Vyve_edit.qxp 31/10/08 12:07 Page 18
Current Issues
Figure 4: European Organisation for Research and Treatment of
The Next Step – EU Clinical Trials Directive
Cancer Headquarters Budget 1997–2007
Amendment or New Legislation?
The EORTC and numerous research groups outside the field of oncology
14
recommend revision of the current Directive. Formal recognition of the
12
non-commercial sponsor is a major first step. Second, a risk-based
10
approach is needed. The US Food and Drug Administration (FDA) allows
8
certain regulatory exemptions for non-interventional trials and trials that
(millions)
6
€ study life-threatening diseases or diseases that lack good therapeutic
4
alternatives, such as cancers. To maintain a high level of quality, the
2
same GCP standards should apply to both commercial and non-
0
1997 2000 2005 2007 commercial sponsors. Support mechanisms such as fee waivers as well
Year
as public funding and sponsorship would assist academic sponsors in
meeting these standards. Funding remains a central issue and although
Figure 5: European Organisation for Research and Treatment of
Cancer Study Activation, Recruited Patients and Headquarters
industry and academic clinical trials may address different but
Staff 1997–2007
complementary scientific questions, collaboration is essential.
Partnerships between industry and non-commercial academic research
3
30
160
organisations can only lead to a win–win situation.
19
These measures will
140
ensure early access to innovative agents and novel therapeutic
25
120
modalities, increase the competitiveness of European research and, most
20 importantly, provide patients with the best available therapy.
100
15 80 TC employees
In spite of the challenges presented by the EU CTD, the EORTC is actively
60
seeking concrete solutions to remain at the forefront of cancer research
10
TC new studies and new patients x10
while working to improve the Directive. A current EORTC priority is
40
Number EOR
5
research that will identify individual cancer gene signatures that
20
clinicians will use one day to ‘tailor’ patient treatment using ‘targeted’
Number EOR
0
0
therapies. Another priority is the study of rare types of cancers in small
1997 2000 2005 2007
Year ‘niche’ patient populations. Both initiatives demand scientific expertise
EORTC new studies EORTC new patients EORTC HQ staff
but also significantly large patient numbers, which in turn requires a
pan-European, multinational, harmonised approach to co-ordinate and
costs and increasing demands on resources are encountered daily. The conduct such trials. If Europe is to remain competitive and expand its
EORTC Headquarters budget has increased six-fold over recent years capacity for medical research excellence, innovative solutions, novel
(see Figure 4) and the staff has tripled despite a drop in the number of research approaches, successful industry–academia partnerships and,
newly activated clinical trials and number of treated patients (see above all, a new EU CTD are clearly needed. ■
Figure 5). This is largely related to national legislation and
implementation of the EU CTD. Less interest in academic research Acknowledgements
means important scientific questions are left unanswered, fewer and The authors wish to thank Dr Colette Lukan for her medical writing and
fewer clinical trials are initiated and patients are denied access to editorial contribution in the preparation of this manuscript. Diane van
potentially beneficial therapies. In order to guarantee the survival of Vyve is grateful for the ongoing support provided by Dr Denis Lacombe,
academic clinical research in Europe, urgent steps are needed to EORTC Scientific Director. This research project was supported by Fonds
reverse this downward spiral. Cancer (Belgium).
1. European Organisation for Research and Treatment of (Directive 2001/20/EC) and Perspectives for the Future, 15. Raaschou Beck G, Senior Director, International QA, Global
Cancer. Available at: www.eortc.be Report on the conference held on 3 October 2007 at the Quality Assurance, Ferring Pharmaceuticals A/S, Copenhagen,
2. Meunier F, Dubois N, Negrouk A, et al., Throwing a wrench EMEA, London. Available at: ec.europa.eu/enterprise/ corresponding author of Raaschou Beck G, An overview of
in the works?, Lancet Oncol, 2003;4:717–19. pharmaceuticals/pharmacos/docs/doc2007/2007_11/ clinical studies in Denmark, Monitor, February 2007
3. Hartmann M, Hartmann-Vareilles F, The clinical trials ec_emea_conference_on_clinical%20_trials.pdf 16. BIA–EuropaBio White Paper: Promoting consistency of
directive: how is it affecting Europe’s non-commercial 9. Article 1 of the EU CTD. implementation and interpretation of the Clinical Trials
research?, PLOS Clinical Trials, 2006;e13. 10. Meunier F, Lacombe D, European Organisation for Research Directive across EU member States, 2006.
4. Hemminki A, Kellokumpu-Lehtinen PL, Harmful impact of EU and Treatment of Cancer’s point of view, Lancet, 2003;362: 17. Detailed guidance for the request for authorisation of a
clinical research directive, BMJ, 2006;332:501–2. 663. clinical trial on medicinal product for human use to the
5. Moulton B, Two Years Later: The Impact of the EU Directive, 11. van Vyve D, Lacombe D, Minas V, Drucker L, Insurance issues competent authorities, notification of substantial
Applied Clinical Trials, 2006. and clinical research, E-learning course insurance issues and amendments and declaration of the end of the trial, October
6. Hearn J, Sullivan R, The impact of the ‘Clinical Trials’ clinical research, version July 2007. Available at: 2005, European Commission, Enterprise Directorate-General.
directive on the cost and conduct of non-commercial cancer www.eclin.be/uk/home.asp Available at: ec.europa.eu/enterprise/pharmaceuticals/
trials in the UK, Eur J Cancer, 2007;43:8–13. 12. Austria, Belgium, France, Ireland, Italy, The Netherlands, eudralex/vol-10/11_ca_14-2005.pdf
7. European Parliament and Council of the European Union, Poland, Portugal. 18. Ohmann C, Demotes J, Sweeney F, et al., Alternative
Directive 2001/20/EC of the European Parliament and the 13. Austria, Belgium, France, Italy, Ireland, Luxembourg, The monitoring procedures in investigator initiated trials,
Council of 4 Apr 2001. OJ L 121:34-44. Available at: Netherlands, Portugal. KKS/ECRIN/TMF Meeting Report, April 2006.
www.eortc.be/Services/Doc/clinical-EU-directive-04-April- 14. Fischer K, General Manager, CEO, Assign Clinical Research 19. Piccart M, Goldhirsch A, Wood W, et al., Keeping faith with
01.pdf gmbh, Assign Group, Austria, corresponding author of trial volunteers, Nature, 2007;446(7132):137–8.
8. European Commission–European Medicines Agency Mazalin K, Fischer K, Pharmaceutical Clinical Research in
Conference on the Operation of Clinical Trials Directive Austria and Hungary, Monitor, February 2007.
18 EUROPEAN ONCOLOGY
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