The European Medicines Agency (EMA) defines a biomarker as “a biological molecule found in blood, other body fluids, or tissues that can be used to follow body processes and diseases in humans and animals”. Given the therapeutic potential of the human microbiomes in the clinical setting, microbiome-based biomarkers could help understanding, predicting, and treating both intestinal and extra-intestinal diseases.

The Human Microbiome Action project, funded by the European Commission through the Horizon 2020 programme, is seeking experts in microbiome-based biomarker development to participate in a Delphi survey. The goal of the survey is to assess multiple stakeholders’ knowledge and perceptions of the definition and qualification procedures of microbiome-based biomarkers, as well as the factors limiting translation from discovery into qualification and clinical implementation.

The call is for researchers, healthcare professionals, government institutions and private companies involved in microbiome research and development

The question of discovery, qualification, demonstration of clinical relevance and implementation of microbiome-based biomarkers is seen as crucial for improving clinical decision-making processes and the robustness of microbiome-based drug development. The Delphi survey is therefore necessary, considering the current lack of sufficient data from the literature on the topic.

In this research practice, experts reach a consensus on a topic through a series of questionnaires that are refined and developed over time. The Delphi questionnaire will be organized into two rounds, where participants respond to a set of questions within a designated time frame. The results of the first round of responses will be analysed and sent back to the same participants for a second round, during which experts will have the opportunity to reassess and justify their answers if they fall outside the group’s median. It is important to note that the Delphi survey is completely anonymous to ensure fair and unbiased responses from all participants.

Who qualifies for participation as an expert? The call is for individuals with significant experience and knowledge in microbiome-based biomarker discovery and qualification, including researchers, healthcare professionals, government institutions and private companies involved in microbiome research and development.

The results of the survey will be published in a position paper, providing insights on the state of the art of microbiome-based biomarkers, identifying the challenges and proposing recommendations to address them. That information will help guide future research and development efforts in the field, leading to a more effective process for bringing microbiome-based biomarkers to the clinic.

If you are an expert in microbiome-based biomarker development, we encourage you to take part in the survey by emailing delphi@pharmabiotic.org. And don’t forget to help with reaching more experts by spreading the word to your network.

 

About the Human Microbiome Action project

Human Microbiome Action is an EU-funded Horizon 2020 project (grant agreement No 964590) aimed at maximising the impact of European microbiome research and innovation to tackle the epidemics of chronic diseases. At the core of the project’s mission is the ambition to create coherence and harmony in the way microbiome research is and will be performed. By aligning, structuring and providing direction to EU microbiome research, the project will contribute to achieving a healthcare system that takes into consideration the human microbiome. The Human Microbiome Action project will develop a range of guidance documents and recommendations for researchers, public health officials and industry stakeholders to provide roadmaps for necessary foundations and key actions that allow for aligned microbiome research in the future. The project will last for three years (2021–2024) and is coordinated by Joël Doré from the French National Research Institute for Agriculture, Food and the Environment (INRAE).

For further information, please visit the Human Microbiome Action website or sign up to the Human Microbiome Action newsletter.