Physicians Should Be Critical of Adverse Event Reporting in Clinical Trials Interview with:

Paolo Bossi MD Medical Oncologist Head and Neck Cancer Department  IRCCS Istituto Nazionale dei Tumori Foundation Milan, Italy

Dr. Paolo Bossi

Paolo Bossi MD
Medical Oncologist
Head and Neck Cancer Department
IRCCS Istituto Nazionale dei Tumori Foundation
Milan, Italy What is the background for this study? What are the main findings?

Response: Precise, clear and unbiased reporting of adverse events (AE) is essential to ensure safety of the new drugs.

It is crucial also in engaging patients and physicians in a shared decision making: before starting a new treatment I need to discuss with my pt what are the expected benefits and what the toxicities of a new drugs.
However, in parallel to the discovery and development of new drugs, little attention has been paid to modernization of the way of collecting toxicities.

This line of reasoning is particularly true for new or “relatively new” drugs, such as immunotherapy (IT) and targeted agents (TT).

So, we analysed all the trials that lead to the approval of TT or IT from 2000 – 2015 retrieved by FDA database.

We found a low quality in reporting adverse events regarding the following fields:

– description of recurrent and late toxicities and duration of the AEs (in more than 90% of the trials);
– description of time of occurrence (86% of the trials) and indication of all AEs, instead of only those occurred with a frequency above a fixed threshold (75% of the trials)
– Limitations in methods for presenting adverse events, in description of the toxicities leading to therapy withdrawal and in follow up interval assessment were present in more than 50% of the analysed papers
– Dose reductions due to AEs were not reported in 1 out of 3 trials. What should readers take away from your report?

Response: I think that in reading the results of a new trial it is essential for a physician being critical and ask for higher quality in the report of adverse events.
Moreover, we should be aware that the dimension of time was the least considered one. I’m used to call it as the third axis. We always take into consideration severity and frequency, but not the third axis of duration when we speak about adverse events. What recommendations do you have for future research as a result of this study?

Response: It is important to consider the “toxicity over time” as a recent and clear paper published on Lancet Oncology suggested.

Moreover, listening to the patients’ voice, through the implementation of Patient Reported Outcome (PRO)-Common Toxicity Criteria for Adverse Events (CTCAE), a precious instruemnt, complementary and not alternative to physician-assessed adverse events. Thank you for your contribution to the community.

Citation: ESMO 2016 abstract

Systematic review of adverse events reporting in clinical trials leading to approval of targeted therapy and immunotherapy P. Bossi1, L. Botta2, P. Bironzo3, C. Sonetto3, G. Musettini4, A. Sbrana4, V. Di Giannantonio1, L. Locati1, M. Di Maio5, A. Antonuzzo4 1 Head & Neck Unit, Fondazione IRCCS – Istituto Nazionale dei Tumori, Milan, Italy, 2 Evaluative Epidemiology, Preventive and Predictive Medicine, Fondazione IRCCS – Istituto Nazionale dei Tumori, Milan, Italy, 3 Medical Oncology, Azienda Ospedaliero-Universitaria ASOU San Luigi Gonzaga, Orbassano, Italy, 4 Medical Oncology, Azienda Ospedaliera Universitaria S.Chiara, Pisa, Italy, 5 Medical Oncology, Università di Torino, Ospedale Mauriziano, Turin, Italy
Note: Content is Not intended as medical advice. Please consult your health care provider regarding your specific medical condition and questions.

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