AACR-FDA-NCI Cancer Biomarkers Collaborative Consensus Report: Advancing the Use of Biomarkers in Cancer Drug Development

Recent discoveries in cancer biology have greatly increased our understanding of cancer at the molecular and cellular level, but translating this knowledge into safe and effective therapies for cancer patients has proved to be challenging. There is a growing imperative to modernize the drug development process by incorporating new techniques that can predict the safety and effectiveness of new drugs faster, with more certainty, and at lower cost. Biomarkers are central to accelerating the identification and adoption of new therapies, but currently, many barriers impede their use in drug development and clinical practice. In 2007, the AACR-FDA-NCI Cancer Biomarkers Collaborative stepped into the national effort to bring together disparate stakeholders to clearly delineate these barriers, to develop recommendations for integrating biomarkers into the cancer drug development enterprise, and to set in motion the necessary action plans and collaborations to see the promise of biomarkers come to fruition, efficiently delivering quality cancer care to patients. Clin Cancer Res; 16(13); 3299–318. ©2010 AACR.

[1]  M. Cronin,et al.  Gene expression and benefit of chemotherapy in women with node-negative, estrogen receptor-positive breast cancer. , 2006, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[2]  D. Bjorkman,et al.  University of Utah School of Medicine. , 2010, Academic medicine : journal of the Association of American Medical Colleges.

[3]  Peter J. Klenow,et al.  Sematech: purpose and performance. , 1996, Proceedings of the National Academy of Sciences of the United States of America.

[4]  David Moher,et al.  Towards complete and accurate reporting of studies of diagnostic accuracy: the STARD initiative. Standards for Reporting of Diagnostic Accuracy. , 2003, Clinical chemistry.

[5]  Laura A. Levit,et al.  Beyond the HIPAA Privacy Rule: Enhancing Privacy, Improving Health Through Research. Washington, DC: National Academies Press , 2009 .

[6]  Soonmyung Paik,et al.  Use of archived specimens in evaluation of prognostic and predictive biomarkers. , 2009, Journal of the National Cancer Institute.

[7]  Joseph A DiMasi,et al.  Economics of new oncology drug development. , 2007, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[8]  Van,et al.  A gene-expression signature as a predictor of survival in breast cancer. , 2002, The New England journal of medicine.

[9]  Stefan H. Thomke,et al.  Millennium Pharmaceuticals, Inc. , 1999, Personalized medicine.

[10]  J. Dancey,et al.  A Perspective on Challenges and Issues in Biomarker Development and Drug and Biomarker Codevelopment , 2009, Journal of the National Cancer Institute.

[11]  L. V. van't Veer,et al.  Validation and clinical utility of a 70-gene prognostic signature for women with node-negative breast cancer. , 2006, Journal of the National Cancer Institute.

[12]  Daniel J Sargent,et al.  Clinical trial designs for predictive biomarker validation: theoretical considerations and practical challenges. , 2009, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[13]  Katherine C Sexton,et al.  Development of the ISBER Best Practices for Repositories: Collection, Storage, Retrieval and Distribution of Biological Materials for Research. , 2012, Biopreservation and biobanking.

[14]  D. DeMets,et al.  Biomarkers and surrogate endpoints: Preferred definitions and conceptual framework , 2001, Clinical pharmacology and therapeutics.

[15]  H. Bartsch,et al.  International Agency for Research on Cancer. , 1969, WHO chronicle.

[16]  M. Cronin,et al.  A multigene assay to predict recurrence of tamoxifen-treated, node-negative breast cancer. , 2004, The New England journal of medicine.

[17]  M. Duffy,et al.  A personalized approach to cancer treatment: how biomarkers can help. , 2008, Clinical chemistry.

[18]  William D. Figg,et al.  Validation of Analytic Methods for Biomarkers Used in Drug Development , 2008, Clinical Cancer Research.

[19]  Susanne B Haga,et al.  Ethical, legal, and social implications of biobanks for genetics research. , 2008, Advances in genetics.

[20]  G. Gasparini,et al.  Is tailored therapy feasible in oncology? , 2006, Critical reviews in oncology/hematology.

[21]  International Society for Biological and Environmental Repositories , 2005 .

[22]  Richard Simon,et al.  The Use of Genomics in Clinical Trial Design , 2008, Clinical Cancer Research.

[23]  David Moher,et al.  Towards complete and accurate reporting of studies of diagnostic accuracy: The STARD Initiative. , 2003, Radiology.

[24]  A. Park,et al.  CENTER FOR DRUG EVALUATION AND RESEARCH , 2009 .

[25]  Daniel F Hayes,et al.  Prognostic and predictive factors revisited. , 2005, Breast.

[26]  M. Duffy,et al.  Predictive markers in breast and other cancers: a review. , 2005, Clinical chemistry.

[27]  Table of Valid Genomic Biomarkers in the Context of Approved Drug Labels , 2009 .

[28]  Helen M. Moore,et al.  2009 Biospecimen research network symposium: advancing cancer research through biospecimen science. , 2009, Cancer research.

[29]  Janice M. Reichert,et al.  Development trends for new cancer therapeutics and vaccines. , 2008, Drug discovery today.

[30]  Innovation OR Stagnation.  Challenge and Opportunity on the Critical Path to New Medical Products , 2004 .

[31]  J. Weinstein,et al.  Biomarkers in Cancer Staging, Prognosis and Treatment Selection , 2005, Nature Reviews Cancer.