Editorial: Negative trials in ovarian cancer: is there such a thing as too much optimism? (popular article by # views)

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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

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 Conclusion

As 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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