Investigator Global Assessment Scale
Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD™) Scale
Eli Lilly and Company (Lilly) has worked with numerous atopic dermatitis experts, including International Eczema Council advisors and Industry experts, to develop the Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD™) scale for use in clinical trials.
As part of this collaborative effort, Lilly has offered to make the vIGA-AD™ scale and the investigator training modules available to other companies and academic groups. The final version of the vIGA-AD™ scale can be downloaded from the link below, and is provided subject to the terms of the CC BY-ND 4.0 license to other companies or investigators (see https://creativecommons.org/licenses/by-nd/4.0/). The training video and certification exam are stored at Trifecta (www.trifectaclinical.com), and Lilly has given Trifecta permission to provide access to these materials for training investigators. Trifecta can add slides preceding the training video with information pertaining to the sponsor and their study. To access the training video and certification please contact Trifecta directly (Brent Smith, firstname.lastname@example.org, or Eric Zudak, email@example.com).
To ensure harmonization in the assessment of atopic dermatitis patients, no additional modifications can be made to the vIGA-AD™ scale without Lilly’s written consent. This royalty-free non-exclusive license will allow all to use the vIGA-AD™ scale in clinical studies, as long as they give credit to Lilly as already stated at the bottom of the scale and in the training video. Any translations of the scale developed by Lilly will also be made available. In the event that new translations are needed, we ask that copies of the translations created, and certification of the linguistic validation, be provided back to Lilly and IEC, in order to be made available to all and ensure consistency in the use of the scale across geographies.”
Please note that during the development of this scale, drafts as well as the final version of the vIGA-AD™ were shared with the FDA for input, and FDA’s feedback was incorporated into the final morphological descriptors. Subsequently the FDA indicated that the final vIGA-AD™ scale was adequate to assess the efficacy of one of Lilly’s products being developed for the treatment of atopic dermatitis. If a company chooses to use the vIGA-AD™ in their clinical programs, they should contact Lilly if the FDA or another health authority requests changes to the scale. Such additional modifications to the scale will need to be carefully considered in light of the goal of this collaborative harmonization effort.
The IEC and Lilly would like to thank all of the Academic and Industry experts who participated in the development and validation of the vIGA-AD™ scale. If there are any questions regarding the use of the vIGA-AD™ scale and training module, please contact the IEC or Eli Lilly and Company (www.lilly.com; Fabio Nunes, firstname.lastname@example.org).