AE "worsening of underlying disease" not reportabel per study protocol. What to do if event fulfills Seriousness criteria?
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Nanda Brattinga-van Roekel
In our clinical study protocols (mainly oncology trials) we include the following statement "Worsening of the subject's condition for which the study treatment is being used, is not considered an AE.". However what would you do if the subject is hospitalized for a procedure/surgery to treat the event "worsening of underlying disease."? Would you ask the investigator to report this as an SAE? In this particular case it concerns a bronchoscopy for bronchial obstruction caused by the tumor mass.
Thank you for your thoughts.
Interesting question, which is frequently stated in protocols for oncology and life-threatening conditions. The current statement only applies to an AE, unless it is also mentioned somewhere else in the protocol that death, life-threatening worsening of subject’s condition and hospitalisation follow that rule. The protocol and its associated CRF must ensure that worsening of subject’s condition, whatever its seriousness, is adequately collected by the investigational site. If the current protocol limits the condition to AEs, therefore, any SAE should be reported as per normal practice. As the site is also aware that the subject worsened because of a bronchial obstruction caused by the tumour mass, the sponsor medical team should assess medically that event and complies with Detailed guidance on the collection, verification and presentation of adverse event/reaction reports arising from clinical trials on medicinal products for human use (‘CT-3’), section 7.11.4, paragraph 121, “Events may occur during a clinical trial which do not fall within the definition of SUSAR and thus are not subject to the reporting requirements for SUSARs, even though they may be relevant in terms of subject safety.”
D Chesnais have provided a quite correct response from guidelines perspective. Yes, worsening of the condition is required to be considered as SAE and collected in safety database. However, if your protocol mentions not to collect such AE then such SAE may not be shared with HA/IEC.