The national biomarker development alliance: Confronting the poor productivity of biomarker research and development

Expert Review of Molecular Diagnostics

Volumn 15, Issue 2, 2015, Pages 211-218

  Poste, George ^a   Compton, Carolyn C ^a   Barker, Anna D ^a  

^a ARIZONA STATE UNIVERSITY   (United States)

Author keywords

biomarkers; biospecimens; regulatory; reimbursement; standards; systems approaches; validation

Indexed keywords

BIOLOGICAL MARKER;

CLINICAL LABORATORY; CLINICAL PRACTICE; CLINICAL PROTOCOL; CLINICAL RESEARCH; DIAGNOSTIC ACCURACY; DIAGNOSTIC TEST; FUNDING; HEALTH STATUS; HUMAN; MOLECULAR DIAGNOSIS; MOLECULAR DIAGNOSTICS; PERSONALIZED MEDICINE; PRACTICE GUIDELINE; REIMBURSEMENT; REVIEW; SCIENTIFIC LITERATURE; MEDICAL RESEARCH; METABOLISM; REPRODUCIBILITY; RESEARCH; STANDARD; STANDARDS;

BIOLOGICAL MARKERS; BIOMEDICAL RESEARCH; HUMANS; INDIVIDUALIZED MEDICINE; MOLECULAR DIAGNOSTIC TECHNIQUES; PRACTICE GUIDELINES AS TOPIC; REFERENCE STANDARDS; REPRODUCIBILITY OF RESULTS; RESEARCH;

EID: 84921323111     PISSN: 14737159     EISSN: 17448352     Source Type: Journal    
DOI: 10.1586/14737159.2015.974561     Document Type: Review

References (45)

1. Harris TJ, McCormick F. The molecular pathways of cancer. Nat Rev Clin Oncol 2010;7:251-65
2. Kelloff GJ, Sigman CC. Cancer biomarkers selecting the right drug for the right patient. Nat Rev Drug Discov 2012;11:201-14
3. Poste G. Biospecimens, biomarkers and burgeoning data: the imperative for more rigorous research standards. Trends Mol Med 2012;18:717-22
4. Van Roosbroeck K, Pollet J, Calin GA. miRNAs and long noncoding RNAs as biomarkers in human disease. Expert Rev Mol Diag 2013;13:183-204
5. National Research Council. Towards precision in medicine. Building a knowledge network for biomedical research and a new taxonomy of disease. National Academies Press, Washington, DC; 2011
6. Kern SG. Why your new cancer biomarker may never work: recurrent patterns and remarkable diversity in biomarker failures. Cancer Res 2012;72:6097-101
7. Drucker G, Krapfenbauer K. Pitfalls and limitations in translation from biomarker discovery to clinical utility in predictive personalised medicine. The EPMA Journal 2013;4:7
8. Pavlou MD, Diamindis EP, Blaustig IM. The long journey of cancer biomarkers from bench to the clinic. Clin Chem 2012;159: 147-57
9. Ransohoff DF, Gourlay ML. Sources of bias in specimens for research about molecular markers for cancer. J Clin Oncol 2010;28: 698-704
10. Hayes DF, Allen J, Compton C, et al. Breaking a vicious cycle. Science Trans Med 2013;5:196-203
11. Poste G, Carbone DP, Parkinson DR, et al. Leveling the playing field: bringing development of biomarkers and molecular diagnostics up to the standards for drug development. Clin Cancer Res 2012;18: 1515-23
12. Lindor RA, Alloco SJ, Cheatham L, et al. Regulatory and reimbursement regulation. Sci Trans Med 2013;5(176):p176cm3
13. Poste G. Bring on the biomarkers. Nature 2011;496:156-7
14. NBDA. Available from: www.NBDAbiomarkers.com
15. Compton C. Getting to personalized cancer medicine. Taking out the garbage. Cancer 2007;110:1641-3
16. Ransohoff DF. Lessons from controversy: ovarian cancer screening and serum proteomics. J. Nat. Cancer Inst 2005;97: 315-19
17. Hewitt SM, Badre SS, Trude LD. Impact of preanalytic factors on the design and application of integral biomarkers from discovery therapy. Clin Cancer Res 2012;18:1524-9
18. Moore HM, Compton CC, Alper J, Vaught JB. International approaches to advancing biospecimen science. Cancer Epidemiol Biomarkers Prev 2011;20:729-32
19. Fullerton SM, Anderson NR, Guzauskas G, et al. Meeting the governance challenges of next generation biorepository research. Sci Trans Med 2010;2:1-4
20. Thompson M, Werner C. Wireless and mobile monitoring: bringing healthcare home. Medtech Insight 2011;13:33-42
21. Begley CG, Ellis LM. Drug development: raise standards for preclinical cancer research. Nature 2012;483:531-3
22. Prinz F, Schlange T, Asadullah K. Believe it or not: how much can we rely on published data on potential drug targets. Nat Rev Drug Disc 2011;10:712-19
23. National Research Council. Evolution of translational omics: lessons learned and the path forward. National Academies Press; Washington, DC: 2012
24. Alberts B, Kirschner MW, Tilghman S, et al. Rescuing US biomedical research from its systemic flaws. Proc Nat Acad Sci USA 2014;111:5773-7
25. Veeraraghavalu K, Zhang C, Miller C, et al. Comment on Apo-E directed therapeutics rapidly clear b- Amyloid and reverse deficits in AD mouse models. Science 2013;340: 924-6
26. Fang FC, Steen RG, Casadevali A. Misconduct accounts for the majority of retracted scientific publications. Proc Natl Acad Sci USA 2012;109:17028-33
27. Rifai N, Altman DG, Bossuyt PM. Reporting bias in diagnostic and prognostic studies. Time for action. Clin Chem 2008;54:1101-3
28. Andre F, McShane LM, Micheils S, et al. Biomarker studies: a call for comprehensive biomarker study registry. Nat Rev Clin Oncol 2011;8:171-6
29. Sridharan L, Greenland P. Editorial policies and publication bias: the importance of negative studies. Arch Int Med 2009;169: 1022-3
30. Reitsma JB, Moous KG, Bossuyt DM, et al. Systematic reviews of studies quantifying the accuracy of diagnostic tests and markers. Clin Chem 2012;58:1534-5
31. DeAngelis CD, Drazen JM, Frizelle FA, et al. Clinical trial registration: a statement from the International Committee of Medical Journal Editors. JAMA 2005;292: 1363-4
32. Korevaar DA, Ochodo EA, Bossuyt PMM, et al. Publication and reporting of test accuracy studies registered in ClinicalTrials. gov. Clin Chem 2014;60:651-9
33. National Research Council. Digital Infrastructure for the Learning Health System. National Academies Pres. Washington, DC; 2011
34. National Research Council. Refining processes for the co-development of genome-based therapeutics and companion diagnostic tests: workshop summary. National Academies Press; Washington, DC: 2014
35. Koboldt DC, Steinberg KM, Larson DE, et al. The next-generation sequencing revolution and its impact on genomics. Cell 2013;155:27-38
36. Green RC, Berg JS, Grody WW, et al. ACMG recommendations for reporting incidental findings in clinical exome and genome sequencing. Genet Med 2013;15: 565-74
37. Berg JS, Adams M, Nassar N, et al. An informatics approach to analyzing the Incidentalome. Genet Med 2013;15:36-44
38. Whirl-Carrillo M, McDonagh EM, Hebert JM, et al. Pharmacogenetics knowledge for personalized medicine. Clin Pharmacol Ther 2012;92:414-17
39. Lam HY, Clark MJ Chen R, et al. Performance comparison of whole-genome sequencing platforms. Nat Biotechnol 2012;30:78-82
40. Dewey FG, Grove MG, Pan C, et al. Clinical interpretation and implications of whole genome sequencing. JAMA 2014;311:1035-44
41. National Science Foundation. Cyberinfrastructure for 21st Century Science and Engineering (CIF21). Available from: http://www.nsf.gov/pubs/2012/nsf12051.pdf
42. Joly Y, Dove Es, Knoppers BM, et al. Data sharing in the post-genome world: the experience of the International Cancer Genome Consortium (ICGC) data access compliance office (DACO). PLOS Comp. Biol 2012;8:e1002549
43. Stein DT, Terry SF. Reforming biobank consent policy: a necessary move away from broad consent toward dynamic consent. Genet Tests Mol Biomarkers 2013;17:855-6
44. Borgman CL. The conundrum of sharing research data. J Am Soc Inf Sci Technol 2011;6:1059-78
45. Kaye J, Hawkins N. Data sharing policy design for consortia: challenges for sustainability. Genome Med 2014;6:4-8