These are the first recommendations for harms reporting in clinical trial manuscripts on drugs specific to osteoarthritis (OA); however, they may also apply to other diseases, particularly for anti-OA drugs that are also used in other fields.

The European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO) safety working group emphasizes that all treatment-emergent adverse events (AEs) should always be considered for harms reporting, with no frequency threshold; any interpretation of a relationship between an AE and the treatment studied should only be included in the discussion section of the manuscript, when comparing the results with findings from other clinical trials or meta-analyses.

Clear and specific guidance is provided for the reporting of each type of AE, with particular emphasis that all specific severe and serious events should always be reported; henceforth, information on adverse drug biological effects should also be reported.