In Pursuit of Greater Reproducibility and Credibility of Early Clinical Biomarker Research

Parkinson's Disease Biomarkers: Where Are We and Where Do We Go Next?

“…Proteomics shares some of these challenges, but has nevertheless yielded promising biomarkers as discussed below. A major confounder with “‐omics” techniques is batch effect, in which measures vary by the batch tested, resulting at least in part from susceptibility to even minor changes in testing conditions . Finally, genotyping and gene expression profiling is another route for unbiased biomarker discovery.…”

“…Replication and reproducibility within the context of biomarker development involves re‐demonstration of the performance of a putative biomarker in different cohorts and by different investigators. Assay standardization is essential to minimize the impact of technical differences in biomarker measurement on reported results . Application of appropriate statistical analyses, public sharing of datasets, and transparent reporting of methods will be key to replication and reproducibility.…”

“…A major confounder with "-omics" techniques is batch effect, in which measures vary by the batch tested, resulting at least in part from susceptibility to even minor changes in testing conditions. 10 Finally, genotyping and gene expression profiling is another route for unbiased biomarker discovery. For example, untargeted transcriptomics (analysis of mRNA patterns) can help identify differential patterns of gene expression that could be specific to the PD population, as described further below.…”

“…Assay standardization is essential to minimize the impact of technical differences in biomarker measurement on reported results. 10 Application of appropriate statistical analyses, public sharing of datasets, and transparent reporting of methods will be key to replication and reproducibility. Higher standards for publication of first-reported biomarkers are needed, especially in the case of biomarkers identified through an unbiased approach.…”

“…Higher standards for publication of first-reported biomarkers are needed, especially in the case of biomarkers identified through an unbiased approach. 9,10 Other important considerations are ease of use, accessibility, and requirements for dissemination of a given biomarker. If a biomarker performs well yet is costly, requires unwieldy equipment, and/or necessitates extensive personnel training, these impracticalities may prevent widespread adoption.…”