The frequency of medical reversals in a cross-sectional analysis of high-impact oncology journals, 2009–2018

Abstract

Background Identifying ineffective practices that have been used in oncology is important in reducing wasted resources and harm. We sought to examine the prevalence of practices that are being used but have been shown in RCTs to be ineffective (medical reversals) in published oncology studies. Methods We cross-sectionally analyzed studies published in three high-impact oncology medical journals (2009–2018). We abstracted data relating to the frequency and characterization of medical reversals. Results Of the 64 oncology reversals, medications (44%) represented the most common intervention type (39% were targeted). Fourteen (22%) were funded by pharmaceutical/industry only and 56% were funded by an organization other than pharmaceutical/industry. The median number of years that the practice had been in use prior to the reversal study was 9 years (range 1–50 years). Conclusion Here we show that oncology reversals most often involve the administration of medications, have been practiced for years, and are often identified through studies funded by non-industry organizations.

Differential Treatment Effects of Subgroup Analyses in Phase 3 Oncology Trials From 2004 to 2020

“…Interestingly, in this study, trials that did not meet the primary end point seemed to conduct more subgroup effect tests than trials meeting the primary end point. Trialists should consider limiting the number of subgroup effects tested to those that are prespecified with directionality, biologically plausible, and supported by prior evidence, or if a larger number of effects are explored, controlling for type I error risk …”

“…Trialists should consider limiting the number of subgroup effects tested to those that are prespecified with directionality, biologically plausible, and supported by prior evidence, or if a larger number of effects are explored, controlling for type I error risk. 13,19,42,[52][53][54][55] While subgroup analyses were prevalent, most subgroup analyses in this study were not associated with DTE claims. This finding was similar to a prior study 10 evaluating forest plots presented at ASCO annual meetings.…”

Frequency and Characteristics of Trials Using Medical Writer Support in High-Impact Oncology Journals

“…have used these journals in a previous study. 7 We searched for studies published between May 1, 2021, and May 1, 2022. Included studies needed to (1) report on a cancer trial, (2) report original research, and (3) evaluate a tumor-targeting treatment.…”

Where are randomized trials necessary: Are smoking and parachutes good counterexamples?

“…The lawsuits surrounding Wyeth Pharmaceutical's hormone therapies, Premarin and Prempro, are emblematic of this issue, as the corporation failed to adequately disclose the dangers associated with its medicines, resulting in patient harm, a loss of faith in physicians prescribing them and concern about national healthcare recommendations supporting their use 18 . Elsewhere, we have detailed hundreds of instances of medical reversal and its associated harms in recent decades, reversals that may have been averted had rigorous randomized data been cultivated prior to widespread adoption 9,13,19,20 …”

“…18 Elsewhere, we have detailed hundreds of instances of medical reversal and its associated harms in recent decades, reversals that may have been averted had rigorous randomized data been cultivated prior to widespread adoption. 9,13,19,20 Why, then, do people often assert that RCTs are unfeasible, despite the danger associated with adopting therapies without randomized data? How is it appropriate to use smoking and parachutes as counterexamples?…”