Bio-Specimen Sub-Core: is responsible for establishing, maintaining and the strategic planning for the MIHRA virtual bio-repository establishing bio-specimen tracking, storing and shipping infrastructure as well as working with global institutions arriving at policies and agreements for specimen use and transfer. This effort is co-led by Dr. Latika Gupta and Dr. Christian Lood with support from Childhood Arthritis & Rheumatology Research Alliance (CARRA), Cure JM, The Francis Crick Institute, Pediatric Rheumatology European Society (PReS), The Myositis Association (TMA), University of Birmingham-UK, University College London (UCL) Juvenile Dermatomyositis Cohort Biomarker Study and Repository (JDCBS), University of Washington Seattle Children’s Hospital, as well as collaborative efforts with our industry partners.
The MIHRA Bio-Specimen Sub-Core guides the establishment of standardized protocols and infrastructure to ensure high quality research samples for clinical projects. This is in contrast to the important work being done by other entities such as the Accelerating Medicines Partnership (AMP) Autoimmune & Immune-Mediated Disease Program (AIM). Whereby efforts like AMP/AIM focus is on utilizing biospecimen samples to understand cellular and molecular interactions leading to inflammation and autoimmunity. MIHRA goals are tied to identifying the degree to which varied procedural techniques retains a biospecimen’s highest correlation to clinical disease activity profiles, thus striving for testing procedures that render bio-sample testing results as accurate a reflection as possible of the clinical disease state to inform clinically meaningful outcomes coupled with clinical data. While at the same time understanding that the most accurate of procedures may or may not be globally feasible, accessible or cost-effective, MIHRA will thus seek global community guidance on these pivotal issues to inform guidelines that are feasible and also to resource mapping may help guide strategies to better resource collection sites.
These efforts will be carried out via:
1. A community-wide unmet need survey to assess current resources, identify prospective collection needs, evaluate sample quality, and determine confidence levels in various sample variables. By inventorying existing samples and documenting techniques used across labs, we will identify ready collaborators and collaborators needing assistance to create a comprehensive framework.
2. Protocol development for standardization of specimen collection, handling, analysis, and logistics (e.g. shipping, sharing, transfer) to ensure the highest level of specimen preservation insuring clinical meaningfulness.
The anticipated results of these phases are to secure the quality & accuracy of future natural history and clinical phenotyping projects:
Phase I: Biospecimen Processing and Storage for Rare Rheumatic Diseases: Year 0: Understand the needs and barriers experienced regarding biospecimen collection and storage. Achieve consensus on a data-driven protocol, endorsed by interdisciplinary experts, to harmonize the operations of future feasible biobanking efforts for rare disease research.
Phase II: Development of Standardized Protocol: Year 1: Test consensus protocols achieved above and determine optimized processing and storage conditions for serum and plasma samples with autoimmune muscle disease to acquire consistent high-quality data over a broad range of biomarkers of inflammation and autoimmunity.
Phase III: Validation of Standardized Protocol in Juvenile Dermatomyositis (JDM): Year 2: Using a well-defined JDM population to increase efficiency of discovery, the goal is to define the protocol with the most clinical significance, e.g. disease activity monitoring and/or patient stratification based on phenotype. A broad panel of biomarkers of inflammation and autoimmunity measured in plasma and serum from JDM patients (n=50) collected from US centers. MIHRA thanks The Myositis Association for their generous funding support for this project.
Phase IV: Decentralized Retrospective Biobank: Year 2-3: Establish a global biobanking network for IIM clinical research to address critical challenges: limited clinical data linkage, poor disease phenotype documentation, insufficient specimen variety for comprehensive pathway analyses, inadequate sample storage, lack of ethnic diversity, and absence of stratified samples representing various disease stages.
Phase IV: Decentralized Prospective Biobank: Year 3-5: Establish a global network of prospective biobanks using the harmonized, feasible biospecimen collection protocol for myositis clinical research to address critical challenges in the field. Large multi-site collaborations will (i) increase diversity and equity, (ii) augment the ability to stratify samples based on disease stage, (iii) identify rare subtypes of diseases, and (iv) move toward comprehensive pathway analyses.
MIHRA welcomes you & your team to participate in the consensus process, standardization collaboration, become a MIHRA community member and you will be notified in Jan/Feb 2025 upon engagement initiation and for more details contact the MIHRA leads. 