Kerri Fitzgerald

DocwireNews

Language used to describe adverse events (AEs) experienced in clinical trials often downplays the&nbsp;potential harms, according to a study published in&nbsp;The&nbsp;BMJ.&nbsp;Researchers evaluated&nbsp;122&nbsp;randomized trials published&nbsp;in 2016&nbsp;in five top-tier clinical journals&nbsp;(New England Journal of Medicine,&nbsp;Lancet,&nbsp;Lancet Oncology,&nbsp;JAMA, and&nbsp;Journal of Clinical Oncology)&nbsp;and found&nbsp;that 43%&nbsp;(n=53)&nbsp;used&nbsp;the following&nbsp;words to describe AEs:&nbsp;tolerable, favorable,&nbsp;acceptable, manageable, feasible, and&nbsp;safe.&nbsp;Fourteen did not report any data on severe&nbsp;AEs, 22 had no data on serious events, and two had no data on deaths.&nbsp;<blockquote class="twitter-tweet" data-width="500" data-dnt="true">
Reporting harms more transparently in trials of <a href="https://twitter.com/hashtag/cancer?src=hash&amp;ref_src=twsrc%5Etfw">#cancer</a> drugs &#8294;<a href="https://twitter.com/bmj_latest?ref_src=twsrc%5Etfw">@bmj_latest</a>&#8297; Yes, toxic effects can be brutal-let's get real &amp; report/describe accurately <a href="https://twitter.com/hashtag/meded?src=hash&amp;ref_src=twsrc%5Etfw">#meded</a> <a href="https://twitter.com/hashtag/oncology?src=hash&amp;ref_src=twsrc%5Etfw">#oncology</a> &#8294;<a href="https://twitter.com/subatomicdoc?ref_src=twsrc%5Etfw">@subatomicdoc</a>&#8297; <a href="https://twitter.com/hashtag/btsm?src=hash&amp;ref_src=twsrc%5Etfw">#btsm</a> &#8294;<a href="https://twitter.com/BTSMchat?ref_src=twsrc%5Etfw">@BTSMchat</a>&#8297; <a href="https://t.co/Smn1SilonP">https://t.co/Smn1SilonP</a>
&mdash; Hedy Wald (@hedy_wald) <a href="https://twitter.com/hedy_wald/status/1061587214994415616?ref_src=twsrc%5Etfw">November 11, 2018</a>
</blockquote><script async src="https://platform.twitter.com/widgets.js" charset="utf-8"></script>&ldquo;We consider the lack of harms reporting and the use of subjective terms to describe harms&nbsp;to be poor reporting practice,&rdquo;&nbsp;said lead author&nbsp;Bishal&nbsp;Gyawali, MD, PhD,&nbsp;of Brigham and Women&rsquo;s&nbsp;Hospital&nbsp;at Harvard Medical School in&nbsp;Boston.&nbsp;<blockquote class="twitter-tweet" data-width="500" data-dnt="true">
An excellent analysis by <a href="https://twitter.com/oncology_bg?ref_src=twsrc%5Etfw">@oncology_bg</a> Never take any thing at its face value.. Analyse every article critically before it changes your practice <a href="https://twitter.com/hashtag/nofalsehopes?src=hash&amp;ref_src=twsrc%5Etfw">#nofalsehopes</a> <a href="https://twitter.com/ESSOnews?ref_src=twsrc%5Etfw">@ESSOnews</a> Reporting harms more transparently in trials of cancer drugs <a href="https://t.co/8i1now4zZZ">https://t.co/8i1now4zZZ</a>
&mdash; Dr Pankaj K Garg (@DrPankajGarg) <a href="https://twitter.com/DrPankajGarg/status/1059653437472808960?ref_src=twsrc%5Etfw">November 6, 2018</a>
</blockquote><script async src="https://platform.twitter.com/widgets.js" charset="utf-8"></script>In 39 trials&nbsp;that&nbsp;reported AE&nbsp;data,&nbsp;the rates of serious&nbsp;AEs were higher in the experimental arm than in the control arm in 30 trials (77%),&nbsp;serious&nbsp;AEs were higher in 26 of 31 trials (84%), and deaths were higher in 34 of 51 trials (66%).&nbsp;&ldquo;Thus, despite using terms such as &lsquo;favorable&rsquo;&nbsp;and&nbsp;&lsquo;tolerable&rsquo;&nbsp;to describe the harms profiles of new treatments, the trials often showed a greater number of harms than in the control arms,&rdquo;&nbsp;the authors wrote.&nbsp;<a href="https://twitter.com/ColeWayant_OK/status/1058538365144969216">https://twitter.com/ColeWayant_OK/status/1058538365144969216</a>&ldquo;Not fully reporting the harms of cancer drugs is of&nbsp;particular concern&nbsp;because cancer drugs usually provide modest benefits at high costs&mdash;in terms of both price and toxicities,&rdquo; the researchers concluded. &ldquo;Describing harms as acceptable or tolerable in trials is unacceptable, irrespective of incidence and risk, as it makes a subjective judgment.&nbsp;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.&rdquo;&nbsp;<a href="https://proddocwire.wpengine.com/docwire-pick/immune-checkpoint-inhibitors-fatal/">With the increased use of immune checkpoint inhibitors, fatal toxicities continue to occur.</a>&nbsp;<a href="https://proddocwire.wpengine.com/hematology-oncology/fda-approves-biosimilar-agent-to-reduce-risk-of-infection-in-patients-with-cancer/">FDA approves biosimilar agent to reduce the risk of infection in patients with cancer.</a>&nbsp;Source:&nbsp;<a href="https://www.bmj.com/content/363/bmj.k4383">The&nbsp;BMJ</a>

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

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