Studies with negative results often presented in not-negative ways at conferences
Even when trial results are formally negative, they are often presented in a not-negative way during oral presentations at medical conferences, according to a research letter published in JAMA Oncology.
In this quality improvement analysis, researchers reviewed oral presentations of phase 3 randomized clinical trials presented at the American Society of Clinical Oncology and European Society for Medical Oncology congresses from 2017 through 2019.
Formally negative trials were classified according to the reasons of not-negative conclusions: numerically better outcome in the experimental arm, despite a nonsignificant P value; emphasis on positive subgroup(s); emphasis on positive secondary end point(s); and noninferiority interpretation of a negative superiority trial.
Of the 208 randomized clinical trials analyzed, 91 had formally negative results, and 26 had a not negative conclusion. In these studies, authors emphasized a numerically better outcome in the experimental arm in 50% of cases, the positive result in ≥1 subgroups in 46%, and the positive result in ≥1 secondary end points in 38%. In 27% of cases, authors interpreted post hoc the study as a noninferiority design.
In 2017, 2018, and 2019, the proportion of negative studies with not-negative conclusions was 22%, 13%, and 47%, respectively. Not-negative conclusions were noted in 30% of nonprofit studies and 26% of for-profit studies.
“Each of the reasons used to underline positive aspects of a formally negative result should be presented with caution, avoiding diffusion of methodologically equivocal statements,” wrote the authors.
Di Maio M, Audisio M, Cardone C, et al. The Use of Not-Negative Conclusions to Describe Results of Formally Negative Trials Presented at Oncology Meetings. JAMA Oncol. 2020;6(6):926–927. doi:10.1001/jamaoncol.2020.0475