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Showing content from https://pubmed.ncbi.nlm.nih.gov/26967260/ below:

The Scientific Impact of Positive and Negative Phase 3 Cancer Clinical Trials

. 2016 Jul 1;2(7):875-81. doi: 10.1001/jamaoncol.2015.6487. The Scientific Impact of Positive and Negative Phase 3 Cancer Clinical Trials

Affiliations

¹ SWOG Statistical Center, Fred Hutchinson Cancer Research Center, Seattle, Washington.
² Fred Hutchinson Cancer Research Center, Seattle, Washington.
³ SWOG Group Chair's Office/Knight Cancer Institute, Oregon Health and Science University, Portland.
⁴ Columbia University, New York, New York.

PMID: 26967260
PMCID: PMC4945370
DOI: 10.1001/jamaoncol.2015.6487

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The Scientific Impact of Positive and Negative Phase 3 Cancer Clinical Trials

Joseph M Unger et al. JAMA Oncol. 2016.

. 2016 Jul 1;2(7):875-81. doi: 10.1001/jamaoncol.2015.6487. Affiliations

¹ SWOG Statistical Center, Fred Hutchinson Cancer Research Center, Seattle, Washington.
² Fred Hutchinson Cancer Research Center, Seattle, Washington.
³ SWOG Group Chair's Office/Knight Cancer Institute, Oregon Health and Science University, Portland.
⁴ Columbia University, New York, New York.

PMID: 26967260
PMCID: PMC4945370
DOI: 10.1001/jamaoncol.2015.6487

Item in Clipboard

Abstract

Importance: Positive phase 3 cancer clinical trials are widely hailed, while trials with negative results are often interpreted as scientific failures. We hypothesized that these interpretations would be reflected in the scientific literature.

Objective: To compare the scientific impact of positive vs negative phase 3 cancer clinical treatment trials.

Design, setting, and participants: We examined the phase 3 trial history of SWOG, a national cancer clinical trials consortium, over a 30-year period (1985-2014). Scientific impact was assessed according to multiple publication and citation outcomes. Citation data were obtained using Google Scholar. Citation counts were compared using generalized estimating equations for Poisson regression. Any trial that was formally evaluated for the randomized treatment comparison was included for analysis of publication and citation outcomes. Trials were categorized as positive if they achieved a statistically significant result in favor of the new experimental treatment for the protocol-specified primary end point. Trials were categorized as negative if they achieved a statistically significant result in favor of standard therapy or a null result with no statistically significant benefit for either the experimental or standard therapy.

Main outcomes and measures: Impact factors for the journals publishing the primary trial results, and the number of citations for the primary trial articles and all secondary articles associated with the trials.

Results: Ninety-four studies enrolling n = 46 424 patients were analyzed. Twenty-eight percent of trials were positive (26 of 94). The primary publications from positive trials were published in journals with higher mean (SD) 2-year impact factors (28 [19] vs 18 [13]; P = .007) and were cited twice as often as negative trials (mean per year, 43 vs 21; relative risk, 2.0; 95% CI, 1.1-3.9; P = .03). However, the number of citations from all primary and secondary articles did not significantly differ between positive and negative trials (mean per year, 55 vs 45; relative risk, 1.2; 95% CI, 0.7-2.3; P = .53).

Conclusions and relevance: The scientific impact of the primary articles from positive phase 3 randomized cancer clinical trials was twice as great as for negative trials. But when all of the articles associated with the trials were considered, the scientific impact between positive and negative trials was similar. Positive trials indicate clinical advances, but negative trials also have a sizeable scientific impact by generating important scientific observations and new hypotheses and by showing what new treatments should not be used.

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Conflict of interest statement

Conflict of Interest Disclosures: The authors have no disclosures.

Figures
Figure 1

Number of citations by calendar…

Figure 1

Number of citations by calendar year for primary manuscripts (Panel A), secondary manuscripts…

Figure 1

Number of citations by calendar year for primary manuscripts (Panel A), secondary manuscripts (Panel B), and the combination of primary and secondary manuscripts (Panel C). Calendar year was truncated at 1995 for presentation purposes. The number of publications that were at risk of citation are shown below each panel.

Figure 2

Average citations by year after…

Figure 2

Average citations by year after primary manuscript publication for primary manuscripts (Panel A)…

Figure 2

Average citations by year after primary manuscript publication for primary manuscripts (Panel A) and both primary and secondary manuscripts (panel B). The solid blue lines show the model fitted results for positive trials, and the solid red lines show the model fitted results for negative trials. The blue crosses indicate observed mean number of citations for positive trials, and the red dots indicate observed mean number of citations for negative trials. The observed and fitted values occurring prior to the primary manuscript publication year were due to citations from secondary publications associated with a given trial (for instance, articles reporting on the trial design). Citation counts for the first 20 years after primary manuscript publication were included for the analysis of primary manuscripts only. For the analysis of primary and secondary manuscripts, citation counts from 5 years prior to primary manuscript publication to 20 years after primary manuscript publication were included.