Recent Statistical Contributions to Medical Device Development

Therapeutic Innovation & Regulatory Science
Brian L WiensScott M Berry

Abstract

Clinical trials in the development of new medical device products are in many ways analogous to clinical trials in the development of new drug or biologic products. However, the differences are important and not always intuitive to a statistician with only experience supporting development of drug and biologic products. In this paper we discuss some of the interesting differences with focus on the statistical innovation that is coming out of the medical device area. We discuss examples of the differences in clinical trial design and effects of these differences on clinical development programs.

References

Dec 29, 2007·Journal of Biopharmaceutical Statistics·Gregory Campbell
Dec 29, 2007·Journal of Biopharmaceutical Statistics·Heng Li, Lilly Q Yue
Dec 29, 2007·Journal of Biopharmaceutical Statistics·Brian P Hobbs, Bradley P Carlin
Dec 29, 2007·Journal of Biopharmaceutical Statistics·Gene Pennello, Laura Thompson
Aug 20, 2010·Journal of Biopharmaceutical Statistics·Boris G Zaslavsky
Feb 1, 2011·Contemporary Clinical Trials·Hanna KuusistoTapani Keränen
Nov 24, 2011·Journal of Cataract and Refractive Surgery·Marie-José TassignonVeva De Groot
Sep 15, 2012·Analytical Sciences : the International Journal of the Japan Society for Analytical Chemistry·Yuichi IwakiRyuichi Arakawa
Mar 26, 2013·Biostatistics·Noah Simon, Richard Simon

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Citations

Nov 17, 2015·The New England Journal of Medicine·Jordan J FeldUNKNOWN ASTRAL-1 Investigators

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