title: Systematic qualitative review of randomised trials conducted in nonsmall cell lung cancer with a noninferiority or equivalence design.
abstract: The use of noninferiority randomised trials for patients with advanced non-small cell lung cancer has emerged during the past 10-15 years but has raised some issues related to their justification and methodology. The present systematic review aimed to assess trial characteristics and methodological aspects. All randomised clinical trials with a hypothesis of noninferiority/equivalence, published in English, were identified. Several readers extracted a priori defined methodological information. A qualitative analysis was then performed. We identified 20 randomised clinical trials (three phase II and 17 phase III), 11 of them being conducted in strong collaboration with industry. We highlighted some deficiencies in the reports like the lack of justification for both the noninferiority assumption and the definition of the noninferiority margin, as well as inconsistencies between the results and the authors' conclusions. CONSORT guidelines were better followed for general items than for specific items (p<0.001). Improvement in the reporting of the meth"odology of noninferiority/equivalence trials is needed to avoid misleading interpretation and to allow readers to be fully aware of the assumptions underlying the trial designs. They should be restricted to limited specific situations with a strong justification why a noninferiority hypothesis is acceptable.
authors.affiliation: Data Centre, Institut Jules Bordet, Université Libre de Bruxelles, Brussels, Belgium marianne.paesmans@bordet.be.
authors.forename: Marianne
authors.initials: M
authors.lastname: Paesmans
authors.affiliation: Thoracic Oncology Dept, Regional Institute of Oncology Iasi, University of Medicine and Pharmacy, "Gr. T. Popa", Iasi, Romania.
authors.forename: Bogdan
authors.initials: B
authors.lastname: Grigoriu
authors.affiliation: Pneumology Dept, CHU Mont-Godinne, Université Catholique de Louvain, Yvoir, Belgium.
authors.forename: Sebahat
authors.initials: S
authors.lastname: Ocak
authors.affiliation: Radiotherapy Dept, Institut Jules Bordet, Université Libre de Bruxelles, Brussels, Belgium.
authors.forename: Martine
authors.initials: M
authors.lastname: Roelandts
authors.affiliation: Pneumology Dept, CHU Lille, University of Lille 2, Lille, France.
authors.forename: Jean-Jacques
authors.initials: JJ
authors.lastname: Lafitte
authors.affiliation: Medical Oncology Dept, CHU Ambroise Paré, Mons, Belgium.
authors.forename: Stéphane
authors.initials: S
authors.lastname: Holbrechts
authors.affiliation: Thoracic Oncology and Intensive Care Dept, Institut Jules Bordet, Université Libre de Bruxelles, Brussels, Belgium.
authors.forename: Thierry
authors.initials: T
authors.lastname: Berghmans
authors.affiliation: Thoracic Oncology and Intensive Care Dept, Institut Jules Bordet, Université Libre de Bruxelles, Brussels, Belgium.
authors.forename: Anne-Pascale
authors.initials: AP
authors.lastname: Meert
authors.affiliation: Radiotherapy Dept, Institut Jules Bordet, Université Libre de Bruxelles, Brussels, Belgium.
authors.forename: Luigi
authors.initials: L
authors.lastname: Moretti
authors.affiliation: Library of Life Sciences, Université de Liège, Liège, Belgium.
authors.forename: Sophie
authors.initials: S
authors.lastname: Danyi
authors.affiliation: Library of Life Sciences, Université de Liège, Liège, Belgium.
authors.forename: Françoise
authors.initials: F
authors.lastname: Pasleau
authors.affiliation: Data Centre, Institut Jules Bordet, Université Libre de Bruxelles, Brussels, Belgium.
authors.forename: Lieveke
authors.initials: L
authors.lastname: Ameye
authors.affiliation: Pneumology Department, CHU Charleroi, Charleroi, Belgium.
authors.forename: Alain
authors.initials: A
authors.lastname: Van Meerhaeghe
authors.affiliation: Thoracic Oncology and Intensive Care Dept, Institut Jules Bordet, Université Libre de Bruxelles, Brussels, Belgium.
authors.forename: Jean-Paul
authors.initials: JP
authors.lastname: Sculier
mesh_terms: D000465:Algorithms; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy*; D017322:Clinical Trials, Phase II as Topic; D017326:Clinical Trials, Phase III as Topic; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy*; D008495:Medical Oncology / Q000379:methods; D016032:Randomized Controlled Trials as Topic; D015203:Reproducibility of Results; D012107:Research Design; D012306:Risk
chemical_list: D000970:Antineoplastic Agents