Statistical Methods for Clinical Validation of Follow-On Companion Diagnostic Devices via an External Concordance Study

Statistics in Biopharmaceutical Research

Volumn 8, Issue 3, 2016, Pages 355-363

  Li, Meijuan ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

Comparator companion diagnostic device; Device drug clinical trial; Device s intended use population; Drug efficacy; Follow on companion diagnostic device; Personalized medicine

Indexed keywords

CLINICAL TRIAL; DRUG EFFICACY; HUMAN; PERSONALIZED MEDICINE; STATISTICAL ANALYSIS; VALIDATION PROCESS;

EID: 84987971505     PISSN: None     EISSN: 19466315     Source Type: Journal    
DOI: 10.1080/19466315.2016.1202859     Document Type: Article

References (9)

1. B.Efron, (1994), “Missing Data, Imputation, and the Bootstrap,” Journal of the American Statistics Association, 426, 463–475.
2. Food and Drug Administration (FDA) (2014), The US Food and Drug Administration:In Vitro Companion Diagnostic Devices Guidance for Industry and Food and Drug Administration Staff 2014. Available at http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm262327.pdf.
3. Food and Drug Administration (FDA) (2016), The US Food and Drug Administration:List of Cleared or Approved Companion Diagnostic Devices (In Vitro and Imaging Tools). Available at http://www.fda.gov/medicaldevices/productsandmedicalprocedures/invitrodiagnostics/ucm301431.htm.
4. W.Leisenring, T.Alonzo, and M.S.Pepe, (2000), “Comparisons of Predictive Values of Binary Medical Diagnostic Tests for Paired Designs,” Biometrics, 56, 345–351.
5. M.J.Li, (2015), “Statistical Consideration and Challenges in Bridging Study of Personalized Medicine,” Journal of Biopharmaceutical Statistics, 25, 397–407.
6. M.J.Li, T.H.Yu, and Y.F.Hu, (2015), “The Impact of Companion Diagnostic Device Measurement Performance on Clinical Validation of Personalized Medicine,” Statistics in Medicine, 34, 2222–2234.
7. C.S.Moskowitz, and M.S.Pepe, (2006), “Comparing the Predictive Values of Diagnostic Tests:Sample Size and Analysis for Paired Study Designs,” Clinical Trials, 3, 272–279.
8. R.G.Newcombe, (1998), “Improved Confidence Intervals for the Difference Between Binomial Proportion Based on Paired Data,” Statistics in Medicine, 17, 2635–2650.
9. Sharma, A., Zhang, G., Aslam, S., Yu, K., Chee, M., and Palma, J. F. (2016), “Novel Approach for Clinical Validation of the cobas KRAS Mutation Test in Advanced Colorectal Cancer,” Molecular Diagnosis and Therapy, 20, 231–240.