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Editorials: open access
(viewed 650 times)
Abstract
Recently, two clinical trials of novel agents in metastatic ovarian
cancer were published: a phase 3 study of nintedanib and a phase 2 study
of volasertib. There seemed to be discordance between the results and
conclusions in the publication of both these trials. Despite not very
optimistic results, the studies concluded optimistically in favor of the
new agents under study. Using these examples, we point out the
discrepancies and the risks of concluding optimistically based on
statistical significance when the actual benefit is minimal. We also
appeal against conducting large phase 3 trials that require significant
resources without good phase 2 evidence for doing so.
Published: 17/08/2016
ReferencesConclusionAs a profession, we must learn to call a spade a spade. Ineffective drugs must be acknowledged as such by the oncology community. Additionally, conducting large phase III trials entails a huge sum of financial, logistic and human resources which is not worth spending on questions that are foolish, ill-supported or over-powered at the outset. Care must be made to clarify if results are statistically or clinically significant, and above all caution should always be observed during the interpretation of clinical trial data. The true lessons of negative trials in ovarian cancer apply broadly to all fields of oncology.
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