[en] 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.
Disciplines :
Oncology
Author, co-author :
Paesmans, Marianne; Institut Jules Bordet, Université Libre de Bruxelles, Brussels, Belgium. > Data Centre
Grigoriu, Bogdan
Ocak, Sebahat
Roelandts, Martine
Lafitte, Jean-Jacques
Holbrechts, Stéphane
Berghmans, Thierry
Meert, Anne-Pascale
Moretti, Luigi
Danyi, Sophie ; Université de Liège > Bibliothèque des Sciences de la vie
Pasleau, Françoise ; Université de Liège > Bibliothèque des Sciences de la vie
Lieveke, Ameye
Van Meerhaeghe, Alain
Sculier, Jean-Paul; Institut Jules Bordet, Université Libre de Bruxelles, Brussels, Belgium. > Thoracic Oncology and Intensive Care Dept
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