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

A major difference between preclinical drug development studies and early clinical biomarker development studies is that the latter are often conducted retrospectively using stored specimens collected in routine clinical care settings or in the context of research studies originally addressing diffe...

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Bibliographic Details
Published in:Clinical and translational science 2017-03, Vol.10 (2), p.58-60
Main Author: McShane, LM
Format: Article
Language:English
Subjects:
Accuracy
Bias
Biomarkers
Clinical outcomes
Clinical trials
Drug development
Epidemiology
Equator
Guidelines
Laboratories
Parameter estimation
Pharmacodynamics
Registration
Reproducibility
Sample size
Statistical analysis
Studies
Tumor markers
Tumors
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Summary:A major difference between preclinical drug development studies and early clinical biomarker development studies is that the latter are often conducted retrospectively using stored specimens collected in routine clinical care settings or in the context of research studies originally addressing different questions. [...]early clinical biomarker research has features of retrospective observational studies that extend beyond the experimentally controlled settings typical for preclinical drug development research. The clinical role for a biomarker‐based test typically falls into one or more of the following categories (see US Food and Drug Administration / National Institutes of Health glossary at https://www.ncbi.nlm.nih.gov/books/NBK326791/): diagnostic, monitoring, pharmacodynamics/response, predictive, prognostic, safety, and susceptibility/risk. Statistical analyses cannot rescue data that are corrupted or generated by terribly flawed study designs; in the opposite direction, inappropriate statistical analyses can lead to misleading results and inappropriate conclusions even when based on high‐quality data. Study sample size and precision of estimated effects or parameters of interest should be reported to indicate the strength of evidence; for example, to help distinguish nonsignificant from convincingly null findings.
ISSN:1752-8054
1752-8062
DOI:10.1111/cts.12449