Researchers discovered misleading reporting of results — or “spin” — for most noninferiority cancer trials included in a systematic review. The team reported these findings in JAMA Network Open.
The researchers defined spin as the “use of specific reporting strategies… to highlight that the experimental treatment is beneficial, despite no statistically significant difference for the primary outcome, or to distract the reader from results that are not statistically significant.”
This distorted reporting suggests positive results despite the absence of statistically significant findings, the researchers noted.
The team examined 52 randomized controlled trials, found on PubMed, that were published between January 1, 2010 (when the US Food and Drug Administration published guidelines for noninferiority trials), and December 31, 2019.
The researchers identified spin in 75.0% of trial reports. Spin was observed in the abstract for 65.4% of studies and in the main text for 73.1% of studies.
Focusing on results of the secondary endpoint or subgroup analysis was the most common spin strategy.
In a univariate analysis, factors associated with higher spin prevalence included lack of data managers, lack of funding from for-profit sources, and novel experimental study treatments.
In a multivariate analysis, factors associated with spin included lack of for-profit funding (odds ratio [OR], 5.20; 95% CI, 1.21-22.29) and novel experimental study treatments (OR, 4.64; 95% CI, 0.98-22.02).
These findings suggest that the organizational structure of a trial might be important for ensuring proper reporting, according to the researchers.
“In this context, data managers might contribute not only to improving data reliability but to reducing the spin incidence in the reports,” the researchers wrote. The team added that journal editors’ efforts could also reduce spin in future trial reports.
Disclosures: One study author disclosed affiliations with several pharmaceutical companies. Please see the original reference for details.
Ito C, Hashimoto A, Uemura K, Oba K. Misleading reporting (spin) in noninferiority randomized clinical trials in oncology with statistically not significant results: A systematic review. Published online December 7, 2021. JAMA Netw Open. doi:10.1001/jamanetworkopen.2021.35765
Source: Medical Bag https://www.medicalbag.com/home/specialties/oncology/misleading-report-results-non-inferiority-cancer-trials-treatment-risk/