Misleading Reporting (Spin) in Noninferiority Randomized Clinical Trials in Oncology With Statistically Not Significant Results

Ito, Chiyo; Hashimoto, Atsushi; Uemura, Kohei; Oba, Koji

doi:10.1001/jamanetworkopen.2021.35765

Cited by 16 publications

(23 citation statements)

References 89 publications

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“…This misleading reporting in clinical trials has been termed “spin.” 10 A recent systematic review of oncologic noninferiority clinical trials that did not meet statistical significance for noninferiority showed that 75% had spin. 11 Compared with a previous review of spin, the authors reported the prevalence of spin in noninferiority clinical trials was higher than superiority clinical trials. Spin strategies included emphasizing trends for primary endpoints, conclusions based on secondary endpoints, or conclusions based on subgroup analyses.…”

Section: Discussionmentioning

confidence: 83%

Ensuring Superior Reporting of Radiation Therapy Noninferiority Trials: A Systematic Review

Arifin¹,

Tan²,

Yan

et al. 2023

Advances in Radiation Oncology

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Section: Discussionmentioning

confidence: 83%

Ensuring Superior Reporting of Radiation Therapy Noninferiority Trials: A Systematic Review

Arifin¹,

Tan²,

Yan

et al. 2023

Advances in Radiation Oncology

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“…Our findings also underscore that all RCTs comparing BCT and TM outcomes were not originally designed to test equivalence or non-inferiority between BCT and TM. It is not ideal to use such RCT findings to establish noninferiority [23,24]. Logistically, not being able to reject the hypothesis that BCT is the same as TM in OS (as designed in a superiority trial) does not provide the desired evidence to establish equivalence of the two arms with pre-defined type I and type II error rates.…”

Section: Discussionmentioning

confidence: 99%

Effectiveness Without Efficacy: Cautionary Tale from a Landmark Breast Cancer Randomized Controlled Trial

Shen¹,

Ning²,

Lin³

et al. 2023

J. Cancer

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Background: "Old" randomized controlled trials established breast conserving therapy (BCT) and total mastectomy (TM) equivalence for treating early breast cancer, whereas recent literature report improved survival with BCT. To reconcile this, we performed a simulation study and re-analyzed B-06 trial data. Methods: We estimated the distributions for overall survival (OS), cumulative incidence functions for breast-cancer-specific death (BCSD) and other causes-specific death (OCSD) by BCT and TM. The restricted mean survival time (RMST) difference and hazard ratio between the two arms were estimated. Given the estimated distributions, we simulated cause-specific death times from each arm, evaluating the power to test treatment difference in OS, BCSD, and OCSD with different sample sizes, follow-up times, and a modified setting by simulating BCT-arm OCSD times from the distribution of patients not receiving radiation. Results: With 200 months follow-up, the average BCT-over-TM gain measured by RMST was 3.7 months for OS and 4.5 months for BCSD. Increasing the trial size to 5,000 per arm, there is a 79.2% chance to detect the OS benefit with RMST and 92.4% for BCSD. A nonproportional increase of OCSD in BCT compared to TM was observed after 144 months, and particularly after 200 months post treatments. When OCSD times of BCT were simulated using patients not receiving radiation, the estimated OS gain increased to 4.4 months, and the power increased to 92.2%. Conclusions:The late excess other-cause-death, likely due to radiation, in the BCT arm and sample size constraints limited the power to report BCT superiority. Given radiation delivered in the era of B-06 trial, BCT and TM remain largely equivalent.

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“…In a scoping review of comparisons between abstracts and full reports in primary biomedical research, Li et al 25 found that the level of consistency ranged from 55% to 95%, which included consistency in designating a primary outcome measure 25. On a related note, some studies looked at the prevalence of spin in the medical literature and a systematic review found that 75% of non-inferiority oncology trials had evidence of misleading reporting (spin) 26. Another study identified spin in 34.5% of abstracts of systematic reviews and meta-analyses in emergency medicine 27.…”

Section: Discussionmentioning

confidence: 99%

Consistency between trials presented at conferences, their subsequent publications and press releases

Rowhani-Farid

Hong

Grewal

et al. 2022

BMJ EBM

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ObjectiveThis study examined the extent to which trials presented at major international medical conferences in 2016 consistently reported their study design, end points and results across conference abstracts, published article abstracts and press releases.DesignCross-sectional analysis of clinical trials presented at 12 major medical conferences in the USA in 2016. Conferences were identified from a list of the largest clinical research meetings aggregated by the Healthcare Convention and Exhibitors Association and were included if their abstracts were publicly available. From these conferences, all late-breaker clinical trials were included, as well as a random selection of all other clinical trials, such that the total sample included up to 25 trial abstracts per conference.Main outcome measuresFirst, it was determined if trials were registered and reported results in an International Committee of Medical Journal Editors-approved clinical trial registry. Second, it was determined if trial results were published in a peer-reviewed journal. Finally, information on trial media coverage and press releases was collected using LexisNexis. For all published trials, the consistency of reporting of the following characteristics was examined, through comparison of the trials’ conference and publication abstracts: primary efficacy endpoint definition, safety endpoint identification, sample size, follow-up period, primary end point effect size and characterisation of trial results. For all published abstracts with press releases, the characterisation of trial results across conference abstracts, press releases and publications was compared. Authors determined consistency of reporting when identical information was presented across abstracts and press releases. Primary analyses were descriptive; secondary analyses included χ2tests and multiple logistic regression.ResultsAmong 240 clinical trials presented at 12 major medical conferences, 208 (86.7%) were registered, 95 (39.6%) reported summary results in a registry and 177 (73.8%) were published; 82 (34.2%) were covered by the media and 68 (28.3%) had press releases. Among the 177 published trials, 171 (96.6%) reported the definition of primary efficacy endpoints consistently across conference and publication abstracts, whereas 96/128 (75.0%) consistently identified safety endpoints. There were 107/172 (62.2%) trials with consistent sample sizes across conference and publication abstracts, 101/137 (73.7%) that reported their follow-up periods consistently, 92/175 (52.6%) that described their effect sizes consistently and 157/175 (89.7%) that characterised their results consistently. Among the trials that were published and had press releases, 32/32 (100%) characterised their results consistently across conference abstracts, press releases and publication abstracts. No trial characteristics were associated with reporting primary efficacy end points consistently.ConclusionsFor clinical trials presented at major medical conferences, primary efficacy endpoint definitions were consistently reported and results were consistently characterised across conference abstracts, registry entries and publication abstracts; consistency rates were lower for sample sizes, follow-up periods, and effect size estimates.RegistrationThis study was registered at the Open Science Framework (https://doi.org/10.17605/OSF.IO/VGXZY).

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Misleading Reporting (Spin) in Noninferiority Randomized Clinical Trials in Oncology With Statistically Not Significant Results

Cited by 16 publications

References 89 publications

Ensuring Superior Reporting of Radiation Therapy Noninferiority Trials: A Systematic Review

Ensuring Superior Reporting of Radiation Therapy Noninferiority Trials: A Systematic Review

Effectiveness Without Efficacy: Cautionary Tale from a Landmark Breast Cancer Randomized Controlled Trial

Consistency between trials presented at conferences, their subsequent publications and press releases

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