Bias in reporting of end points of efficacy and toxicity in randomized, clinical trials for women with breast cancer.

@article{VeraBadillo2013BiasIR,
  title={Bias in reporting of end points of efficacy and toxicity in randomized, clinical trials for women with breast cancer.},
  author={Francisco Emilio Vera-Badillo and Roman Shapiro and Alberto Oca{\~n}a and Eitan Amir and Ian F. Tannock},
  journal={Annals of oncology : official journal of the European Society for Medical Oncology},
  year={2013},
  volume={24 5},
  pages={
          1238-44
        }
}
BACKGROUND Phase III randomized, clinical trials (RCTs) assess clinically important differences in end points that reflect benefit to patients. Here, we evaluate the quality of reporting of the primary end point (PE) and of toxicity in RCTs for breast cancer. METHODS PUBMED was searched from 1995 to 2011 to identify RCTs for breast cancer. Bias in the reporting of the PE and of toxicity was assessed using pre-designed algorithms. Associations of bias with the Journal Impact Factor (JIF… 

Figures and Tables from this paper

Bias in reporting of randomised clinical trials in oncology.

Impact of spin in the abstracts of articles reporting results of randomized controlled trials in the field of cancer: the SPIIN randomized controlled trial.

TLDR
Spin in abstracts can have an impact on clinicians' interpretation of the trial results and there was no statistically significant difference in the clinicians' rating of the importance of the study or the need to run another trial.

Quality of adverse event reporting in phase III randomized controlled trials of breast and colorectal cancer: A systematic review

TLDR
The quality of adverse event (AE) reporting and abstract quality in phase III randomized controlled trials of systemic therapies in breast and colorectal cancer is evaluated.

Adverse event reporting in cancer clinical trial publications.

TLDR
Reporting of adverse events in oncology publications of randomized trials is suboptimal and characterized by substantial selectivity and heterogeneity, which should be established to ensure consistency and provide critical information required for medical decision-making.

Benefit and Harms of New Anti-Cancer Drugs

TLDR
Phase III randomized controlled trials (RCTs) assess clinically important differences in endpoints that reflect benefit to and harm of patients, and there are several examples where reports of new toxicities could only be found in drug labels.

Evaluation of spin in oncology clinical trials.

Inferences about drug safety in phase 3 trials in oncology: Examples from advanced prostate cancer.

TLDR
Rigorous comparison of drug safety was precluded by heterogeneity in AE reporting, variation in AE risks in the placebo arms, and lack of inferential statistical methodology, underscoring considerable opportunities to improve how AE data are collected, analyzed, and interpreted in oncology trials.

Do Contemporary Randomized Controlled Trials Meet ESMO Thresholds for Meaningful Clinical Benefit?

TLDR
Less than one-third of contemporary RCTs with statistically significant results meet ESMO thresholds for meaningful clinical benefit, and this represents only 15% of all published trials.
...

References

SHOWING 1-10 OF 32 REFERENCES

Consistency in the analysis and reporting of primary end points in oncology randomized controlled trials from registration to publication: a systematic review.

  • B. YouH. GanG. PondE. Chen
  • Medicine
    Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • 2012
TLDR
The rates of trial registration and of trials with clearly defined PEPs have improved over time; however, 14% of these trials reported a different PEP in the final publication, highlighting the need for investigators, peer reviewers, and readers to exercise increased awareness and scrutiny of reporting outcomes of oncology RCTs.

Reporting of safety results in published reports of randomized controlled trials.

TLDR
Important heterogeneity and variability in the reporting of harm-related results in publications of RCTs is revealed, especially when results are statistically significant.

Empirical evidence for selective reporting of outcomes in randomized trials: comparison of protocols to published articles.

TLDR
The reporting of trial outcomes is not only frequently incomplete but also biased and inconsistent with protocols and Published articles, as well as reviews that incorporate them, may therefore be unreliable and overestimate the benefits of an intervention.

Factors associated with failure to publish large randomized trials presented at an oncology meeting.

TLDR
A substantial number of large phase 3 trials presented at an international oncology meeting remain unpublished 5 years after presentation, suggesting bias against publishing nonsignificant results is a problem even for large randomized trials.

The impact of outcome reporting bias in randomised controlled trials on a cohort of systematic reviews

TLDR
Outcome reporting bias is an under-recognised problem that affects the conclusions in a substantial proportion of Cochrane reviews and individuals conducting systematic reviews need to address explicitly the issue of missing outcome data for their review to be considered a reliable source of evidence.

Reporting Bias in Drug Trials Submitted to the Food and Drug Administration: Review of Publication and Presentation

TLDR
The publication rate of efficacy trials submitted to the Food and Drug Administration in approved New Drug Applications (NDAs) is determined and the trial characteristics as reported by the FDA with those reported in publications are compared.

When are "positive" clinical trials in oncology truly positive?

The approval of a new drug for cancer treatment by the regulatory authorities, such as the United States Food and Drug Administration or European Medicines Agency, is usually based on the positive

Frequency and reasons for outcome reporting bias in clinical trials: interviews with trialists

TLDR
The prevalence of incomplete outcome reporting is high and affects trial design, conduct, analysis, and reporting and a general lack of consensus regarding the choice of outcomes in particular clinical settings was evident.

Endpoints for assessing drug activity in clinical trials.

TLDR
Compared with overall survival and time to progression, which must be evaluated in randomized trials, response rates can be accurately assessed using a single-arm trial and are optimally evaluated by assessing tumor progression in a randomized trial.

Systematic Review of the Empirical Evidence of Study Publication Bias and Outcome Reporting Bias

TLDR
There is strong evidence of an association between significant results and publication; studies that report positive or significant results are more likely to be published and outcomes that are statistically significant have higher odds of being fully reported.