Minimal requirement for clinical metadata and sample processing in microbiome clinical studies

By Published On: April 30, 2024

IHMCSA Consortium finalized the two-rounds Delphi process to suggest “Minimal requirement for clinical metadata and sample processing in microbiome clinical studies”, aiming at finalizing SOPs on required clinical data and pre-analytics to design clinical trials.

The procedure involved 72 scientists and experts worldwide along the first round, 61 in the second round, with a 85% participation rate from Round 1 to Round 2.

With the emergence of “omics” technologies, indeed, thousands of datasets derived from microbiome research have been deposited: despite the availability of data in public depositories, generalization of microbiome research findings is still difficult.

The main reason for this situation is a lack of common standards for data and metadata in microbiome research which is further exacerbated by missing or insufficient metadata in general. With the recently closed Delphi Survey, the Human Microbiome Action Consortium aimed at standardizing metadata collection, standards, procedures and outcomes for data generation and sharing.

Several topics were analysed, among which the selection of a set of clinical metadata, dietary information and laboratory data that have to be documented in microbiome-based clinical studies, standardizable operating procedures for samples’ treatment and processing, and the collection of direct and indirect microbiome-related outcomes.

With the proposed Delphi process, the consensus was reached for the majority of topics. EF-CLIF, EMBL, EBRIS, OUH and PRI preliminary presented the results yesterday, April 29th, during the workshop organized in Barcelona, at EF-CLIF headquarters. Based on the outcome of the Delphi survey, Human Microbiome Action Consortium will provide recommendations that can be taken up by the community at large to promote coherence and harmony in the way microbiome clinical research is and will be performed.

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