Statistics in the World of Medical Devices: The Contrast with Pharmaceuticals

REFERENCES

• Begg , C. G. ( 1987 ). Biases in the assessment of diagnostic tests . Stat. Med. 6 : 411 – 423 .
   PubMed Web of Science ®Google Scholar
• Beiden , S. V. , Wagner , R. F. , Campbell , G. ( 2000 ). Components-of-variance models and multiple bootstrap experiments: an alternative methodology for random-effects, receiver operating characteristic analysis . Acad. Radiol. 7 : 341 – 349 .
   PubMed Web of Science ®Google Scholar
• Benjamini , Y. , Hochberg , Y. ( 1995 ). Controlling the false discovery rate: A practical and powerful approach to multiple testing . J. Roy. Stat. Soc. B. Met. 57 : 289 – 300 .
   Web of Science ®Google Scholar
• Berry , D. ( 1997 ). Using a Bayesian Approach in Medical Device Development, Technical Report 97-21 . Durham , NC : Duke University Institute of Statistics and Decision Sciences . (Available at http://ftp.isds.duke.edu/WorkingPapers/97-21.ps) .
   Google Scholar
• Campbell , G. ( 2004 ). Some issues in the statistical evaluation of genetic and genomic tests . J. Biopharm. Stat. 14 : 539 – 552 .
   PubMedGoogle Scholar
• Campbell , G. ( 2005 ). The experience in the FDA's center for devices and radiological health with Bayesian strategies . Clin. Trials 2 : 359 – 363 .
   PubMed Web of Science ®Google Scholar
• Campbell , G. , Irony , T. Z. , Lao , C. S. , Li , H. , Pennello , G. , Vishnuvajjala , R. L. , Yue , L. Q. ( 2005 ). Medical devices . Encyclopedia Biostat. 5 : 3119 – 3137 .
   Google Scholar
• Cook , J. A. , Ramsay , C. R. , Fayers , P. ( 2004 ). Statistical evaluation of learning curve effects in surgical trials . Clin. Trials 1 : 421 – 427 .
   PubMedGoogle Scholar
• DeMets , D. L. ( 2000 ). The role of surrogate outcome measures in evaluating medical devices . Surgery 128 : 379 – 385 .
   PubMed Web of Science ®Google Scholar
• DuMouchel , W. ( 1999 ). Bayesian data mining in large frequency tables, with an application to the FDA spontaneous reporting system . Am. Stat. 53 : 177 – 202 .
   Web of Science ®Google Scholar
• Fleming , T. R. , DeMets , D. L. ( 1996 ). Surrogate endpoints in clinical trials: a re we being misled? Ann. Intern. Med. 125 : 605 – 613 .
   PubMed Web of Science ®Google Scholar
• Food and Drug Administration ( 2004 ). Challenge and Opportunity on the Critical Path to New Medical Products . (Available at http://www.fda.gov/oc/initiatives/criticalpath/whitepaper.pdf) .
   Google Scholar
• Food and Drug Administration ( 2005 ). Drug-Diagnostic Co-Development Concept Paper . (Available at http://www.fda.gov/cder/genomics/pharmacoconceptfn.pdf) .
   Google Scholar
• Food and Drug Administration ( 2006a ). Critical Path Opportunities List . (Available at http://www.fda.gov/oc/initiatives/criticalpath/reports/opplist.pdf) .
   Google Scholar
• Food and Drug Administration . ( 2006b ). Guidance for Clinical Trial Sponsors on the Establishment and Operation of Clinical Trial Data Monitoring Committees . (Available at http://www.fda.gov/cber/gdlns/clintrialdmc.htm) .
   Google Scholar
• Food and Drug Administration . ( 2006c ). Draft Guidance for Industry and FDA Staff: Guidance on the Use of Bayesian Statistics for Medical Devices Trials . (Available at http://www.fda.gov/cdrh/osb/guidance/1601.pdf) .
   Google Scholar
• Food and Drug Administration ( 2007 ). Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests; Guidance for Industry and FDA Reviewers . (Available at http://www.fda.gov/cdrh/osb/guidance/1620.html) .
   Google Scholar
• International Conference on Harmonisation ( 1998 ). E9: Statistical Principles for Clinical Trials . (Available at http://www.fda.gov/cber/gdlns/ichclinical.txt) .
   Google Scholar
• Irony , T. Z. , Pennello , G. A. (2001). Choosing an appropriate prior for Bayesian medical device trials in the regulatory setting. In: Proceedings of the Biopharmaceutical Section . Vol. M, #85. Alexandria , Virginia : American Statistical Association.
   Google Scholar
• Kaptchuk , T. J. , Goldman , P. , Stone , D. A. , Stason , W. B. ( 2000 ). Do medical devices have enhanced placebo effects? J. Clin. Epidemiol. 53 : 786 – 792 .
   PubMed Web of Science ®Google Scholar
• Lao , C. S. ( 2000 ). Statistical issues involved in medical device post-marketing surveillance . Drug Inf. J. 34 : 483 – 493 .
   Web of Science ®Google Scholar
• Linnet , K. , Kondratovich , M. ( 2004 ). A partly nonparametric approach for determination of the limit of detection . Clin. Chem. 50 : 732 – 740 .
   PubMed Web of Science ®Google Scholar
• O'Malley , A. J. , Normand , S. T. , Kuntz , R. E. ( 2003 ). Application of models for multivariate mixed outcomes to medical device trials: Coronary artery stenting . Stat. Med. 22 : 313 – 336 .
   PubMed Web of Science ®Google Scholar
• Pepe , M. S. ( 2003 ). The Evaluation of Diagnostic Tests and Biomarkers . London : Oxford Press .
   Google Scholar
• Sargent , D. J. , Conley , B. A. , Allegra , C. , Collette , L. ( 2005 ). Clinical trial designs for predictive marker validation in cancer treatment trials . J. Clin. Oncol. 23 : 2020 – 2027 .
   PubMed Web of Science ®Google Scholar
• Scott , P. E. , Campbell , G. ( 1997 ). Interpretation of subgroup analyses in medical device clinical trials . Drug Inf. J. 32 : 213 – 220 .
   Web of Science ®Google Scholar
• et al. . ( 2006 ). The microarray quality control (MAQC) project shows inter- and intra-platform reproducibility of gene expression measurements . Nat. Biotechnol. 24 : 1151 – 1161 .
   PubMed Web of Science ®Google Scholar
• Siegel , J. P. , O'Neill , R. T. , Temple , R. , Campbell , G. , Foulkes , M. A. ( 2004 ). Independence of the statistician who analyzes unmasked data . Stat. Med. 23 : 1527 – 1529 .
   PubMedGoogle Scholar
• Simon , R. ( 2006 ). Development and evaluation of therapeutically relevant predictive classifiers using gene expression profiling . J. Natl. Cancer Inst. 98 : 1169 – 1171 .
   PubMedGoogle Scholar
• U.S. Code, Title 21, Federal Food, Drug and Cosmetic Act, Part 321(h) (Available at http://www.fda.gov/opacom/laws/fdcact/fdcact1.htm) .
   Google Scholar
• U.S. Code of Federal Regulations, Title 21 (Food and Drugs) (2001). Washington DC: U.S. Government Printing Office, Part 860.7. (Available at http://www.gpoaccess.gov/cfr/index.html) .
   Google Scholar
• Wittes , J. ( 2001 ). Clinical trials of the effectiveness of devices: An analogy with drugs . Surgery 129 : 517 – 523 .
   PubMed Web of Science ®Google Scholar
• Yue , L. Q. ( 2001 ). Design issues in non-inferiority medical device clinical trials . In: Proceedings of the Biopharmaceutical Section . Vol. M. #451 . Alexandria , Virginia : American Statistical Association .
   Google Scholar
• Yue , L. Q. ( 2007 ). Statistical and regulatory issues with the application of propensity score analysis to nonrandomized medical device clinical studies . J. Biopharm. Stat. 17 : 1 – 13 .
   PubMed Web of Science ®Google Scholar
• Zhou , X.-H. , Obuchowski , N. A. , McClish , D. K. ( 2002 ). Statistical Methods in Diagnostic Medicine . New York : John Wiley and Sons .
   Google Scholar
• Zweig , M. H. , Campbell , G. ( 1993 ). Receiver operating characteristic plots: a fundamental evaluation tool in clinical medicine . Clin. Chem. 39 : 561 – 577 .
   PubMed Web of Science ®Google Scholar
• *The views expressed in this paper are those of the author; no official endorsement of this paper by the Food and Drug Administration is intended or should be inferred.
   Google Scholar