What can we learn from oncology surgical trials?
Conducting high-quality prospective clinical trials in surgical oncology remains a challenge, and many seemingly well-designed trials lack this high quality because of inadequate recruitment accrual, lack of clinician interest, or evolution of treatment strategy during the many years over which such trials are conducted. In this Perspectives we examine some of the failures in published surgical oncology trials and discuss why they failed, and we make a critical assessment of the established prospective trial methodology in oncological practice (that is, phase 0, I, II, III and IV trials, and large prospective comparative audits) and how these methods might be used more effectively in future evaluation of cancer-surgery practice.
Institut Bergonie, 229 cours de l'Argonne, Bordeaux 33000, France.
Serge
S
Evrard
Institut Bergonie, 229 cours de l'Argonne, Bordeaux 33000, France.
Pippa
P
McKelvie-Sebileau
Department of Surgery, Leiden University Medical Centre, Albinusdreef 2, 2300 RC, Leiden, Netherlands.
Cornelis
C
van de Velde
Hopital Ambroise Pare, Department of Surgery, 9 Avenue Charles de Gaulle, 92104 Boulogne-Billancourt, France.
Bernard
B
Nordlinger
Department of Surgery, School of Translational Studies, University of Liverpool, and Department of Surgery, Aintree University Hospital, Liverpool L9 7AL, UK.
Graeme
G
Poston
D001943:Breast Neoplasms / Q000175:diagnosis / Q000601:surgery; D002170:Canada; D002986:Clinical Trials as Topic; D055088:Early Detection of Cancer; D006801:Humans; D033183:Interdisciplinary Communication; D009369:Neoplasms / Q000175:diagnosis* / Q000401:mortality / Q000601:surgery*; D016019:Survival Analysis