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Year 2017, Volume: 3 Issue: 2, 106 - 110, 04.07.2017
https://doi.org/10.18621/eurj.284433

Abstract

References

  • [1] Institute NC. "biomarker". NCI Dictionary of Cancer Terms.
  • [2] Colburn W, DeGruttola V, DeMets D, Downing G, Hoth D, Oates J, et al. Biomarkers and surrogate endpoints: preferred definitions and conceptual framework. Biomarkers Definitions Working Group. Clin Pharmacol Ther 2001;69:89-95.
  • [3] Jenkins M, Flynn A, Smart T, Harbron C, Sabin T, Ratnayake J, et al. A statistician's perspective on biomarkers in drug development. Pharm Stat 2011;10:494-507.
  • [4] Schilsky RL, Halabi S. Oncology Clinical Trials: Successful Design, Conduct and Analysis: Demos Medical Publishing; 2009.
  • [5] Mayeux R. Biomarkers: potential uses and limitations. NeuroRx 2004;1:182-8.
  • [6] Gosho M, Nagashima K, Sato Y. Study designs and statistical analyses for biomarker research. Sensors (Basel) 2012;12:8966-86.
  • [7] Mandrekar SJ, Sargent DJ. Clinical trial designs for predictive biomarker validation: theoretical considerations and practical challenges. J Clin Oncol 2009;27:4027-34.
  • [8] Mandrekar SJ, Sargent DJ. Clinical trial designs for predictive biomarker validation: one size does not fit all. J Biopharm Stat 2009;19:530-42.
  • [9] Simon R. Biomarker based clinical trial design. Chin Clin Oncol 2014;3:39.
  • [10] Simon R, Maitournam A. Evaluating the efficiency of targeted designs for randomized clinical trials. Clin Cancer Res 2004;10:6759-63.
  • [11] Freidlin B, Simon R. Adaptive signature design: an adaptive clinical trial design for generating and prospectively testing a gene expression signature for sensitive patients. Clin Cancer Res 2005;11:7872-8.
  • [12] Jiang W, Freidlin B, Simon R. Biomarker-adaptive threshold design: a procedure for evaluating treatment with possible biomarker-defined subset effect. J Natl Cancer Inst 2007;99:1036-43.
  • [13] Wang SJ, O'Neill RT, Hung H. Approaches to evaluation of treatment effect in randomized clinical trials with genomic subset. Pharm Stat 2007;6:227-44.
  • [14] Zhou X, Liu S, Kim ES, Herbst RS, Lee JJ. Bayesian adaptive design for targeted therapy development in lung cancer--a step toward personalized medicine. Clin Trials 2008;5:181-93.
  • [15] Pencina MJ, D'Agostino RB, Steyerberg EW. Extensions of net reclassification improvement calculations to measure usefulness of new biomarkers. Stat Med 2011;30:11-21.
  • [16] Pencina MJ, D'Agostino RB, Vasan RS. Evaluating the added predictive ability of a new marker: from area under the ROC curve to reclassification and beyond. Stat Med 2008;27:157-72.

Study designs in biomarker research

Year 2017, Volume: 3 Issue: 2, 106 - 110, 04.07.2017
https://doi.org/10.18621/eurj.284433

Abstract

In order to advances in
technology, nowadays science is facing to a large variety of biomarkers. Issues
of selecting appropriate study design for biomarkers, facing with a large
number of biomarkers, multiple biomarkers, and usefulness of a new biomarker the
today is more complicated. Current study is an overview of the issues discussed
in studies of biomarkers. 

References

  • [1] Institute NC. "biomarker". NCI Dictionary of Cancer Terms.
  • [2] Colburn W, DeGruttola V, DeMets D, Downing G, Hoth D, Oates J, et al. Biomarkers and surrogate endpoints: preferred definitions and conceptual framework. Biomarkers Definitions Working Group. Clin Pharmacol Ther 2001;69:89-95.
  • [3] Jenkins M, Flynn A, Smart T, Harbron C, Sabin T, Ratnayake J, et al. A statistician's perspective on biomarkers in drug development. Pharm Stat 2011;10:494-507.
  • [4] Schilsky RL, Halabi S. Oncology Clinical Trials: Successful Design, Conduct and Analysis: Demos Medical Publishing; 2009.
  • [5] Mayeux R. Biomarkers: potential uses and limitations. NeuroRx 2004;1:182-8.
  • [6] Gosho M, Nagashima K, Sato Y. Study designs and statistical analyses for biomarker research. Sensors (Basel) 2012;12:8966-86.
  • [7] Mandrekar SJ, Sargent DJ. Clinical trial designs for predictive biomarker validation: theoretical considerations and practical challenges. J Clin Oncol 2009;27:4027-34.
  • [8] Mandrekar SJ, Sargent DJ. Clinical trial designs for predictive biomarker validation: one size does not fit all. J Biopharm Stat 2009;19:530-42.
  • [9] Simon R. Biomarker based clinical trial design. Chin Clin Oncol 2014;3:39.
  • [10] Simon R, Maitournam A. Evaluating the efficiency of targeted designs for randomized clinical trials. Clin Cancer Res 2004;10:6759-63.
  • [11] Freidlin B, Simon R. Adaptive signature design: an adaptive clinical trial design for generating and prospectively testing a gene expression signature for sensitive patients. Clin Cancer Res 2005;11:7872-8.
  • [12] Jiang W, Freidlin B, Simon R. Biomarker-adaptive threshold design: a procedure for evaluating treatment with possible biomarker-defined subset effect. J Natl Cancer Inst 2007;99:1036-43.
  • [13] Wang SJ, O'Neill RT, Hung H. Approaches to evaluation of treatment effect in randomized clinical trials with genomic subset. Pharm Stat 2007;6:227-44.
  • [14] Zhou X, Liu S, Kim ES, Herbst RS, Lee JJ. Bayesian adaptive design for targeted therapy development in lung cancer--a step toward personalized medicine. Clin Trials 2008;5:181-93.
  • [15] Pencina MJ, D'Agostino RB, Steyerberg EW. Extensions of net reclassification improvement calculations to measure usefulness of new biomarkers. Stat Med 2011;30:11-21.
  • [16] Pencina MJ, D'Agostino RB, Vasan RS. Evaluating the added predictive ability of a new marker: from area under the ROC curve to reclassification and beyond. Stat Med 2008;27:157-72.
There are 16 citations in total.

Details

Subjects Health Care Administration
Journal Section Reviews
Authors

Robab Ahmadian

Gokhan Ocakoglu This is me

Publication Date July 4, 2017
Submission Date January 5, 2017
Acceptance Date January 10, 2017
Published in Issue Year 2017 Volume: 3 Issue: 2

Cite

AMA Ahmadian R, Ocakoglu G. Study designs in biomarker research. Eur Res J. July 2017;3(2):106-110. doi:10.18621/eurj.284433

e-ISSN: 2149-3189 


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