Towards an Open Archival Information System Compliant Exchange Format to Ensure Reproducibility of Assays in Cancer Care

Recent studies by Amgen and Bayer showed that only 11% and 25% respectively of reviewed cancer research projects produced scientifically valid results. The awareness of this fact is accompanied by increasingly stringent regulations, which enforce compliance to ensure the ability to validate research results through its proper reproducibility. Furthermore, research undertakings in this field are expensive and the return on investment needs to be secured by research purchasers through proper management of the knowledge that is required for long term result reuse. For example, the provision of personalised medicine is tightly interwoven with the execution of laborious molecular diagnostic assays besides the comprehensive access to all constituents of it to enable full result reproducibility for its later validation. Hence, a key factor for successful utilization of assay findings is a comprehensive preservation support of assay results together with all relevant information that come into existence throughout the phases of an assay lifecycle. The provision of tools and services that provide comprehensive preservation functionalities will dramatically increase the effective support research of personalised medicine in cancer care through improved reproducibility capabilities for later validation.