Investigator Global Assessment ScaleValidated Investigator Global Assessment for Atopic Dermatitis (VIGA-AD™) ScaleEli 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, available in several languages, can be downloaded below and is provided subject to the terms of the CC BY-ND 4.0 license to other companies or investigators. The training and certification exam are available through WCG's InvestigatorSpace® platform, and Lilly has given WCG permission to provide access to these materials for training investigators. 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 appropriate credit is given to Lilly as noted at the bottom of the scale and within the training modules. If developed, additional translations of the scale will also be made available. If new translations are needed, we ask that copies of the translations are created, and certification of the linguistic validation are 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.” The development drafts of this scale and its final version of the vIGA-AD™ were shared with the FDA for input, and FDA’s feedback was incorporated into the final morphological descriptors. 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. Modifications to the scale will need to be carefully considered considering 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 us or WCG Clinical directly at [email protected]. Access the EASI, BSA & TLSS Training Portal
For further reading regarding the vIGA-AD™, please see the following manuscript:
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