Online ISSN: 2149-3189
2015
Monthly
Nicaea Medical Publishing
Türkiye

Study designs in biomarker research

Robab Ahmadian, Gokhan Ocakoglu
  • Robab Ahmadian (Author) Uludag University
  • Gokhan Ocakoglu (Author) Uludag University
DOI
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. 
Keywords
Biomarker, study design, trial
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 references in total.
How to Cite
1.
Ahmadian R, Ocakoglu G. Study designs in biomarker research. Eur Res J. 2017;3(2):106-110. doi:10.18621/eurj.284433
License
Creative Commons License

Copyright (c) 2017 The European Research Journal
This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.

View Vol. 3 No. 2 (2017)

Vol. 3 No. 2 (2017)

Article Information

  • Article Type Review
  • Submitted February 21, 2026
  • Published July 3, 2017
  • Issue Vol. 3 No. 2 (2017)
  • Section Review
  • File Downloads 1154
  • Abstract Views 637
  • Altmetrics
  • Share
Download data is not yet available.