Study Says Clinical Trial Data Needs More Transparent Reporting of Toxicities

Language used to describe adverse events (AEs) experienced in clinical trials often downplays the potential harms, according to a study published in The BMJ. 

Researchers evaluated 122 randomized trials published in 2016 in five top-tier clinical journals (New England Journal of MedicineLancetLancet OncologyJAMA, and Journal of Clinical Oncology) and found that 43% (n=53) used the following words to describe AEs: tolerable, favorable, acceptable, manageable, feasible, and safe. Fourteen did not report any data on severe AEs, 22 had no data on serious events, and two had no data on deaths. 

“We consider the lack of harms reporting and the use of subjective terms to describe harms to be poor reporting practice,” said lead author Bishal Gyawali, MD, PhD, of Brigham and Women’s Hospital at Harvard Medical School in Boston. 

In 39 trials that reported AE data, the rates of serious AEs were higher in the experimental arm than in the control arm in 30 trials (77%), serious AEs were higher in 26 of 31 trials (84%), and deaths were higher in 34 of 51 trials (66%). “Thus, despite using terms such as ‘favorable’ and ‘tolerable’ to describe the harms profiles of new treatments, the trials often showed a greater number of harms than in the control arms,” the authors wrote. 

“Not fully reporting the harms of cancer drugs is of particular concern because cancer drugs usually provide modest benefits at high costs—in terms of both price and toxicities,” the researchers concluded. “Describing harms as acceptable or tolerable in trials is unacceptable, irrespective of incidence and risk, as it makes a subjective judgment. Whether harms are acceptable is for individual patients to decide rather than physicians or trial stakeholders, and the threshold for tolerability to harms will differ from person to person.” 

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Source: The BMJ