Reproducibility or Bust: Design and Methodological Considerations for Biomarker Validation

• Activity Number: 343
• Type: Topic Contributed
• Date/Time: Tuesday, August 11, 2015 : 10:30 AM to 12:20 PM
• Sponsor: Section on Statistics in Genomics and Genetics
• Author(s): Shannon McWeeney*
• Companies: Oregon Health & Science University
• Keywords: Biomarker ; Validation ; FDA ; genomics ; Reproducibility ; regulatory

Abstract

High throughput '-omics' holds great promise for precision medicine. Recent widely publicized cases of premature translation into a clinical setting have many calling for a more thorough examination into the field of translational omics and emphasizing the need for transparency, reproducibility, accuracy, and reliability in biomarker validation. The apparent lack of a transparent pathway for biomarker validation and qualification has been perceived as a barrier to a faster pace of discovery. Highlighting both best practices and "lessons learned", recommendations are presented with regard to both experimental design and methodological considerations throughout this process.