Statistics in the world of medical devices: The contrast with pharmaceuticals

Journal of Biopharmaceutical Statistics

Volumn 18, Issue 1, 2008, Pages 4-19

  Campbell, Gregory ^a  

^a CENTER FOR DEVICES AND RADIOLOGICAL HEALTH   (United States)

Author keywords

Bayesian clinical trials; Diagnostic test evaluation; Pharmacogenomics; Regulatory statistics

Indexed keywords

BAYES THEOREM; CLINICAL EVALUATION; CLINICAL STUDY; DEVICE; EVALUATION; GOVERNMENT REGULATION; INDUSTRY; MARKET; PRIORITY JOURNAL; REVIEW; STATISTICAL ANALYSIS; STATISTICS;

BAYES THEOREM; CLINICAL TRIALS AS TOPIC; EQUIPMENT AND SUPPLIES; HUMANS; PHARMACEUTICAL PREPARATIONS; TECHNOLOGY, MEDICAL;

EID: 37549053304     PISSN: 10543406     EISSN: 15205711     Source Type: Journal    
DOI: 10.1080/10543400701668225     Document Type: Review

References (36)

1. Begg, C. G. (1987). Biases in the assessment of diagnostic tests. Stat. Med. 6:411-423.
2. 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.
3. 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.
4. 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).
5. Campbell, G. (2004). Some issues in the statistical evaluation of genetic and genomic tests. J. Biopharm. Stat. 14:539-552.
6. Campbell, G. (2005). The experience in the FDA's center for devices and radiological health with Bayesian strategies. Clin. Trials 2:359-363.
7. 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.
8. Cook, J. A., Ramsay, C. R., Fayers, P. (2004). Statistical evaluation of learning curve effects in surgical trials. Clin. Trials 1:421-427.
9. DeMets, D. L. (2000). The role of surrogate outcome measures in evaluating medical devices. Surgery 128:379-385.
10. DuMouchel, W. (1999). Bayesian data mining in large frequency tables, with an application to the FDA spontaneous reporting system. Am. Stat. 53:177-202.
11. Fleming, T. R., DeMets, D. L. (1996). Surrogate endpoints in clinical trials: a re we being misled? Ann. Intern. Med. 125:605-613.
12. 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).
13. Food and Drug Administration (2005). Drug-Diagnostic Co-Development Concept Paper. (Available at http://www.fda.gov/cder/genomics/ pharmacoconceptfn.pdf).
14. Food and Drug Administration (2006a). Critical Path Opportunities List. (Available at http://www.fda.gov/oc/initiatives/criticalpath/reports/ opplist.pdf).
15. 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).
16. 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).
17. 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).
18. International Conference on Harmonisation (1998). E9: Statistical Principles for Clinical Trials. (Available at http://www.fda.gov/cber/gdlns/ ichclinical.txt).
19. 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.
20. 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.
21. Lao, C. S. (2000). Statistical issues involved in medical device post-marketing surveillance. Drug Inf. J. 34:483-493.
22. Linnet, K., Kondratovich, M. (2004). A partly nonparametric approach for determination of the limit of detection. Clin. Chem. 50:732-740.
23. 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.
24. Pepe, M. S. (2003). The Evaluation of Diagnostic Tests and Biomarkers. London: Oxford Press.
25. 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.
26. Scott, P. E., Campbell, G. (1997). Interpretation of subgroup analyses in medical device clinical trials. Drug Inf. J. 32:213-220.
27. Shi, L. et al. (2006). The microarray quality control (MAQC) project shows inter-and intra-platform reproducibility of gene expression measurements. Nat. Biotechnol. 24:1151-1161.
28. 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.
29. Simon, R. (2006). Development and evaluation of therapeutically relevant predictive classifiers using gene expression profiling. J. Natl. Cancer Inst. 98:1169-1171.
30. 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).
31. 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).
32. Wittes, J. (2001). Clinical trials of the effectiveness of devices: An analogy with drugs. Surgery 129:517-523.
33. 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.
34. 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.
35. Zhou, X.-H., Obuchowski, N. A., McClish, D. K. (2002). Statistical Methods in Diagnostic Medicine. New York: John Wiley and Sons.
36. Zweig, M. H., Campbell, G. (1993). Receiver operating characteristic plots: a fundamental evaluation tool in clinical medicine. Clin. Chem. 39:561-577.