title: [Rethinking clinical research in surgical oncology. From comic opera to quality control].
abstract: The evidence base for the effectiveness of surgical interventions is relatively poor and data from large, randomized prospective studies are rare with often a poor quality. Many efforts have been made to increase the number of high quality randomized trials in surgery and theoretical proposals have been put forward to improve the situation, but practical implementation of these proposals is seriously lacking. The consequences of this policy are not trivial; with very few patients included in surgical oncology trials, this represents wasted opportunity for advances in cancer treatment. In this review, we cover the difficulties inherent to clinical research in surgical oncology, such as quality control, equipoise, accrual, and funding and promote alternative designs to the randomized controlled trial. Although the classic randomized controlled trial has a valid but limited place in surgical oncology, other prospective designs need to be promoted as a new deal. This new deal not only implicates surgeons but also journal editors, tender jury, as well as regulatory bodies to cover legal gaps currently surrounding surgical innovation.
authors.affiliation: Université de Bordeaux, institut Bergonié, Inserm U1029, 229, cours de l'Argonne, 33076 Bordeaux, France. Electronic address: s.evrard@bordeaux.unicancer.fr.
authors.forename: Serge
authors.initials: S
authors.lastname: Evrard
mesh_terms: D035843:Biomedical Research / Q000191:economics / Q000592:standards; D002986:Clinical Trials as Topic; D006801:Humans; D008495:Medical Oncology / Q000191:economics / Q000592:standards; D009369:Neoplasms / Q000523:psychology / Q000601:surgery*; D018579:Patient Selection; D011446:Prospective Studies; D011786:Quality Control; D016032:Randomized Controlled Trials as Topic / Q000191:economics / Q000592:standards; D012107:Research Design; D012109:Research Support as Topic
keywords: Chirurgie oncologique; Clinical research; Essai pragmatique; Essai prospectif non randomisé; Essai randomisé; Non-randomised prospective study; Pragmatic trial; Randomised control trial; Recherche clinique; Surgical oncology