Table 1.

The AACR-FDA-NCI Cancer Biomarkers Collaborative consensus recommendations in eight critical areas to advance the use of biomarkers in cancer drug development

Biospecimens
    Establish quality standards and promote routine quality assessment of biospecimens acquired for research
    Develop a publicly available national oncology resource of biospecimen reference standards for biospecimen quality assessment and analytic validation
    Promote an infrastructure and climate supportive of biospecimen research
Analytic Performance
    Develop best practices for analytic validation of various analytes and technologies
    Define and implement quality systems for use in assay validation
    Develop universal physical reference standards
Standardization and Harmonization
    Harmonize biomarker validation and qualification terminology
    Develop a set of common data standards in which the community has influence and input
    Define a universal data element set to accompany all high-quality biospecimens
    Create a simple, standard, and efficient informed consent process and document
Bioinformatics
    Implement a common workspace in a federated application environment
    Establish a collection of use cases (i.e., working models) for biomarker development to facilitate the development of appropriate bioinformatics tools
Collaboration and Data Sharing
    Form a model pre-competitive consortium to facilitate sharing scientific information and research operations
    Develop incentives to encourage collaborations among drug sponsors, clinical research sponsors, and regulatory authorities
    Encourage contribution of biospecimen methods data and experimental data to public databases
Regulatory Issues
    Develop best practices on codevelopment of therapeutics and diagnostics
    Develop best practices on evidentiary standards for changes in drug labeling and developing companion diagnostics
    Develop best practices for biomarker assays based on a composite of multiple individual biomarkers
    Develop best practices for retrospective-prospective study designs for clinical qualification of biomarkers
    Develop best practices on adaptive clinical trial designs for using biomarkers in drug development
    Develop best practices on alternative prospective trial designs for companion diagnostics
Stakeholder Education and Communication
    Educate patients and health care providers about the value and need for biospecimen collection
    Increase awareness and understanding of the importance of analytic validation and quality control
    Educate stakeholders in regulatory pathways to accelerate codevelopment of therapeutics and diagnostics
Science Policy
    Identify areas and/or processes that could enhance the environment for biomarker development
    Explore ways to improve reimbursement for biospecimen handling and diagnostic tests
    Address the barriers to biomarker research produced by the HIPAA Privacy Rule