Send Feedback To Inform NIAID’s Approach on Key Immunologic Events in Autoimmune Diseases

Through the Request for Information (RFI): Inviting Comments and Suggestions on the Identification of Key Events in Autoimmune Diseases, NIAID seeks comments from the scientific community about state-of-the-art sampling and analysis techniques to identify key immunologic events underlying the onset, flare, remission, and progression of autoimmune diseases.

NIAID is interested in studying immunologic events during the period preceding an autoimmune disease diagnosis as well as the events that precede a flare or progression. A better understanding could enable faster, more accurate disease diagnosis; earlier, more personalized therapeutic decisions; and opportunities to delay or prevent onset of disease.

Recent studies indicate that autoimmune disease patients can perform minimally invasive self-sampling that is sufficient to describe relevant immune pathways in active autoimmune disease, which raises the possibility that this approach in an at-risk cohort might be a viable approach to elucidating immunologic events in the preclinical period.

Information Requested

NIAID is seeking input on two broad topics:

1. The utility, feasibility, and potential approaches to establishing a cohort of subjects at risk of developing autoimmune diseases and obtaining longitudinal samples from this cohort to identify immunologic events that drive disease onset in a productive, cost-effective, and minimally invasive manner.
2. The feasibility of, potential approaches to, and impact of studies of autoimmune disease patient cohorts to define immunologic events that drive flares and remissions.

Send us feedback on any or all of the following points of interest:

• Autoimmune diseases that exhibit the greatest need for better definition of the preclinical phase, diseases that will yield the greatest impact from this study, and advances in understanding that are achievable in any specific disease
• Autoimmune diseases that exhibit the greatest need for better understanding of the flare-remission cycle, diseases that will yield the greatest impact from this study, and advances in understanding that are achievable in any specific disease
• Immunologic events, phenotypes, or trends that may be most informative in understanding the preclinical and immediate pre-flare period
• Size, composition, and characteristics of at-risk cohorts that are needed to define key immunologic events leading to emerging clinical autoimmune disease or flares
• Recruitment, retention, sampling (e.g., self-sampling vs. centralized sampling vs. a combined approach), and monitoring of cohorts for development of autoimmune diseases
• Nature and frequency of samples that can be self-collected and the corresponding quality of immunologic information extracted from these samples
• Challenges and limitations in assessing cellular immune responses from self-collected samples; priorities that should be assigned when studying the samples; and advances in sample procurement, shipping, processing, storage, and analysis that may be possible now or in the near future to aid studies of this nature
• Frequency of sampling and clinical monitoring appropriate for different autoimmune diseases, given the rate at which at-risk subjects convert to frank disease and the time lag between sampling and diagnosis
• Means for guiding participants to seek appropriate care should autoimmune disease symptoms develop during the study period
• Other topics relevant to efforts to elucidate the immunology of the preclinical phase and flare-remission cycles of autoimmune diseases

How To Submit a Response and Contact Information

Submit comments electronically to NIAID_AutoimmEvents@nih.gov by March 15, 2021.

Take care not to include any proprietary, classified, confidential, or sensitive information.

If you have questions about this RFI, contact Dr. Thomas Esch, NIAID’s scientific research contact.