Studies of new cancer treatments, such as immunotherapies, often fail to report adverse events adequately, a European conference was told yesterday.
Immunotherapies and targeted treatments may trigger unexpected adverse events – but an analysis of studies suggests that most score "poorly" in the way they report recurrent or late-occurring side-effects.
The findings were reported to the conference of the European Society of Medical Oncology in Copenhagen, Denmark.
Italian researchers studied 81 trials of treatments for solid tumours approved by the US Food and Drugs Administration.
They say that more than 90% scored poorly for their reporting of adverse events. Some 86% failed to report adequately when adverse events.
And, they say, 75% only reported adverse events that occurred above a fixed threshold.
Dr Paolo Bossi, from the Istituto Nazionale dei Tumori, Milan, said there were signs of improvement in reporting in recent years, calling for the use of patient reported outcome measures.
He said: “Toxicities of targeted agents and immunotherapy are obviously different from the toxicities we are used to observing and treating due to chemotherapy, and there are some aspects of the toxicities of these newer agents that we are not so well informed about.”
Dr Nathan Cherny, from the Shaare Zedek Medical Center, Jerusalem, Israel, called for "radical" re-evaluation of collection and reporting of adverse events data.
He said: “It is worth noting however, that the published reports of studies represent a summary of a dataset that may not necessarily represent the full data set submitted to licensing authorities for purposes of drug approval and registration.”
Abstract 320 P Systematic review of adverse events reporting in clinical trials leading to approval of targeted therapy and immunotherapy
Leave a Reply