Clinical Research Protocol, Data Management, and Analysis Model for Epidermolysis bullosa (EB) Biomedical Data Acquisitions Towards Precision Medicine of Indonesian Patients

Epidermolysis bullosa (EB), a rare genetic skin disorder, poses significant challenges in treatment management due to its complexity and rarity. In response to the pressing need for more precise treatment approaches, this study presents a robust research protocol, comprehensive data management, and an analytical model for collecting biomedical data from Indonesian EB patients and managing it with the SRIKANDI and InNA. The study, ethically approved by the BRIN Ethical Clearance Commission, aims to fill a critical gap in the skin microbiome data specific to Indonesian EB patients. The proposed methodology for data analysis involves a multidisciplinary approach, integrating bioinformatics and metagenomic analysis to explore the microbiome profile in EB patients. The anticipated results are expected to provide insights into a complex interplay between genetics, microbiome, and clinical manifestations, paving the way for advancements in precision medicine for EB patients. This paper outlines the regulatory framework, research design, population, and sample criteria, and details of data management and analysis. By presenting this research protocol, we aim to contribute to more appropriate treatment toward precision medicine for EB patients in the near future and can be the pilot study of similar research.