Evaluation of selective outcome reporting bias in efficacy endpoints in print and television advertisements for oncology drugs.

e18179 Background: Drug advertisements marketed to consumers and healthcare providers have been the subject of recent debate, and the efficacy endpoints that underpin these advertisements may sway perceptions of drug efficacy. Methods: Using the AdPharm database we extracted data for oncology drug advertisements printed or aired between March 1, 2017 and September 1, 2018. Our primary objective was to evaluate endpoints from television and print advertisements and endpoints from the corresponding published papers. A secondary objective is to identify the frequency of drug advertisements that are aired or printed while overall survival data is immature. Results: We included 74 advertisements for 34 unique oncology drugs and 22 unique indications. Print ads were most common (n = 66) and most print ads were targeted to healthcare providers (n = 55, 83.3%). The 74 advertisements were underpinned by 48 published clinical trials. The primary endpoint of the 48 underpinning trials was most often PFS (n = 25), followed by OS (n = 11) and ORR (n = 7). Primary endpoints of underpinning trials were not reported in 8 (8/74, 10.8%) advertisements. Statistically significant endpoints were reported more often than nonsignificant endpoints (RR 1.42; 95% CI, 1.26 - 1.60). Thirty advertisements (42.3%) ran while OS data was immature. When OS and PFS were statistically significant, they were reported at a significantly higher rate than when not reported (each P < .001). ORR was not preferentially reported based on its statistical significance (RR 1.33; 95% CI, .94 - 1.87). Conclusions: Oncology drug advertisements appear to preferentially report statistically significant endpoints, which is highly suggestive of selective outcome reporting bias. By reporting only endpoints that achieve statistical significance, advertisers may encourage misconceived notions about a drug’s efficacy profile.

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Outcome Reporting bias in Exercise Oncology trials (OREO): a cross-sectional study

10.1101/2021.03.12.21253378 ◽

2021 ◽

Author(s):

Benjamin Singh ◽

Ciarán M Fairman ◽

Jesper F Christensen ◽

Kate A Bolam ◽

Rosie Twomey ◽

...

Keyword(s):

Cross Sectional Study ◽

Reporting Bias ◽

Selective Outcome Reporting ◽

Outcome Reporting Bias ◽

Cross Sectional ◽

Exercise Interventions ◽

Outcome Reporting ◽

Supervised Exercise ◽

Pubmed Database ◽

Exercise Oncology

Background: Despite evidence of selective outcome reporting across multiple disciplines, this has not yet been assessed in trials studying the effects of exercise in people with cancer. Therefore, the purpose of our study was to explore prospectively registered randomised controlled trials (RCTs) in exercise oncology for evidence of selective outcome reporting. Methods: Eligible trials were RCTs that 1) investigated the effects of at least partially supervised exercise interventions in people with cancer; 2) were preregistered (i.e. registered before the first patient was recruited) on a clinical trials registry; and 3) reported results in a peer-reviewed published manuscript. We searched the PubMed database from the year of inception to September 2020 to identify eligible exercise oncology RCTs clinical trial registries. Eligible trial registrations and linked published manuscripts were compared to identify the proportion of sufficiently preregistered outcomes reported correctly in the manuscripts, and cases of outcome omission, switching, and silently introduction of non- novel outcomes. Results: We identified 31 eligible RCTs and 46 that were ineligible due to retrospective registration. Of the 405 total prespecified outcomes across the 31 eligible trials, only 6.2% were preregistered complete methodological detail. Only 16% (n=148/929) of outcomes reported in published results manuscripts were linked with sufficiently preregistered outcomes without outcome switching. We found 85 total cases of outcome switching. A high proportion (41%) of preregistered outcomes were omitted from the published results manuscripts, and many published outcomes (n=394; 42.4%) were novel outcomes that had been silently introduced (median, min-max=10, 0-50 per trial). We found no examples of preregistered efficacy outcomes that were measured, assessed, and analysed as planned. Conclusions: We found evidence suggestive of widespread selective outcome reporting and non-reporting bias (omitted preregistered outcomes, outcome switching, and silently introduced novel outcomes). The existence of such reporting discrepancies has implications for the integrity and credibility of RCTs in exercise oncology.

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