Call for public comment (deadline 30 Nov) – ECMM/MSGERC Aspergillus and Mold Outcome Criteria Working Group

Dear Colleagues,

The ECMM and MSGERC have created 4 Collaborative Working Groups that have been re-defining fungal disease outcomes, as an update to previously published outcome criteria.

We are pleased to invite you to provide comments to our near final draft for the ECMM/MSGERC Aspergillus and Mold Outcome Criteria Working Group, entitled:

“Revised definitions of responses to therapy and study outcomes in clinical trials of aspergillosis and rare mould infections: Mycoses Study Group and European Confederation of Medical Mycology consensus criteria.”

Many of the criteria are unchanged, but subtle changes are listed below:

• Patient and clinician important outcomes: Emphasizing the importance of clinical response versus radiological and mycological response.
• Proposed measurements for clinical and safety responses.
• Refined the differentiation between partial and stable response (success versus failure).
• Proposed solutions for assessing attributable mortality.
• Inclusion of paediatric input.
• Inclusion of FDA, EMA and stakeholder input from Listening Sessions.
• Inclusion of patient involvement in draft reviews.

ACCESS:

Please note, documents are not enabled for editing or downloading in this view.  At this juncture, we are soliciting public feedback.

You may send your feedback by email to Headquarters@msgerc.org.  Please indicate “Aspergillus Feedback” in the subject of your email response. The documents will be viewable until November 30, 2024.

Sincerely,

Martin Hönigl, MD                                                                   Monica Slavin, MD
ECMM Aspergillus/Mold Co-Chair                                         MSGERC Aspergillus/Mold Co-Chair

for the PDF version of this item please click below:
Soliciting Public Comment FINAL 1nov24