Bishal Gyawali, Professor at Queen’s University, shared on LinkedIn:
“From our new editorial (led by Laure-Anne Teuwen and in collaboration with Nathan Cherny) just published in JNCI.
These are not ‘good to have’ items. These are a minimum set of items that should be reported to truly allow informed risk-benefit assessment and shared decision making with patients. I urge you all to ensure that these recommendations are heeded.
If you are writing a trial report, include these. If you are a reviewer, ask for these. If you are a journal editor, make sure these are included. If you are a conference organizer, include these in your guidance for presenters. Together, we can improve the quality of toxicity reporting. And this is the least we can do for our patients.
Box: Recommendations for Improved Adverse Event Reporting in Clinical Trials
- Avoid the use of subjective downplaying terms to describe toxicities.
- Capture toxicity grades, ideally using the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events.
- Report maximum severity as well as onset, duration, and adverse event load.
- Report dose reductions and treatment interruptions.
- Report incidence of serious and fatal adverse events.
- Report quality-of-life impact based on validated tools.”
Title: Improved Adverse Event Reporting: It’s About Time
Authors: Laure-Anne Teuwen, Nathan Cherny, Bishal Gyawali.
Read the full article.
You can also read:
FDA Final Guidances on Clinical Trial Safety Reporting: What Investigators and Sponsors Need to Know
