References

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[2] International Conference on Harmonization (1997) ICH Guideline for Good Clinical Practice. ICH Technical Coordination, London.

[3] British Paediatric Association (1992) Guidelines for the Ethical Conduct of Medical Research Involving Children. British Paediatric Association, London.

[4] United Kingdom Children's Cancer Study Group (UKCCSG) (1999) Code of conduct for clinical trials. UKCCSG Data Centre, 22-28 Princess Road West, Leicester LE1 6TP, UK.

[5] Fayers, P.M., Hopwood, P., Harvey, A., Girling, D.J., Machin, D., and Stephens, R., on behalf of the MRC Cancer Trials Office (1997) Quality of life assessment in clinical trials - guidelines and a checklist for protocol writers: the U.K. Medical Research Council experience. European Journal of Cancer, 33, 20-8.

[6] Hopwood, P., Harvey, A., Davies, J., Stephens, R.J., Girling, D.J., Gibson, D., and Parmar, M.K.B. (1998) Survey of the administration of quality of life (QL) questionnaires in three multicentre randomized trials in cancer. European Journal of Cancer, 34, 49-57.

[7] Medical Research Council (2001) Human Tissue and Biological Samples for use in Research: Operational and Ethical Guidelines. Medical Research Council, London.

[8] World Health Organization (1979) WHO Handbook for Reporting Results of Cancer Treatment. WHO Offset Publication No. 48. World Health Organization, Geneva.

[9] Therasse, P., Arbuck, S.G., Eisenhauer, E.A., Wanders, J., Kaplan, R.S., Rubinstein, L., Verweij, J., Glabbeke, M. van, Oosterom, T., van, Christian, M.C., and Gwyther. S.G. (2000) New guidelines to evaluate the response to treatment in solid tumors. Journal of the National Cancer Institute, 92, 205-16.

[10] Karnofsky, D., and Burchenal, J.H. (1949) The clinical evaluation of chemotherapeutic agents in cancer. In: Evolution of Chemotherapeutic Agents (ed. C.M. Macleod). Columbia University Press, New York.

[11] Oken, M.M., Creech, R.H., Tormey, D.C., Horton, J., Davis, T.E., McFadden, E.T., and Carbone, P.P. (1982) Toxicity and response criteria of the Eastern Cooperative Oncology Group. American Journal of Clinical Oncology, 5, 649-55.

[12] International Union Against Cancer (1997) TNM classification of malignant tumours, 5th edition (eds. L.H. Sobin, and Ch. Wittekind) John Wiley, New York.

[13] Aaronson, N.K., Ahmedzai, S., Bergman, B., Bullinger, M., Cull, A., Duez, N.J., Filiberti, A., Flechtner, H., Fleishman, S.B., de Haes, J.C.J.M., Kaasa, S., Klee, M., Osoba, D., Razavi, D., Rofe, P.B., Schraubs, S., Sneeuw, K., Sullivan, M., and Takeda, F. for the European Organization for Research and Treatment of Cancer Study Group on Quality of Life. (1993) The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. Journal of the National Cancer Institute, 85, 365-76.

[14] Fayers, P., Aaronson, N., Bjordal, K., Curran, D., and Groenvold, M. (1999) EORTC QLQ-C30 scoring manual, second edition. Quality of Life Unit, EORTC Data Center, Brussels.

[15] Aaronson, N.K., Bullinger, M., and Ahmedzai, S. (1988) A modular approach to quality-of-life assessment in cancer clinical trials. Recent Results in Cancer Research, 111, 231-48.

[16] Sprangers, M.A.G., Cull, A., Bjordal, K., Groenvold, M., and Aaronson, N.K., for the EORTC Study Group on Quality of Life (1993) The European Organization for Research and Treatment of Cancer approach to quality of life assessment: guidelines for developing questionnaire modules. Quality of Life Research, 2, 287-95.

[17] Medicines Control Agency (1993) Medicines act 1968: guidance notes on applications for clinical trial exemptions and clinical trial certificates. Medicines Control Agency, London.

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