03425nam 2200697Ia 450 991096467240332120251117011940.01-315-58014-41-317-14191-11-317-14190-31-282-85767-397866128576761-4094-1242-3(CKB)2670000000048227(EBL)592377(OCoLC)679416674(SSID)ssj0000436024(PQKBManifestationID)12127384(PQKBTitleCode)TC0000436024(PQKBWorkID)10426074(PQKB)11774953(Au-PeEL)EBL592377(CaPaEBR)ebr10421628(CaONFJC)MIL922612(Au-PeEL)EBL5293633(CaONFJC)MIL285767(OCoLC)1027177913(MiAaPQ)EBC592377(MiAaPQ)EBC5293633(EXLCZ)99267000000004822720100907d2010 uy 0engur|n|---|||||txtccrePro electronic solutions for patient-reported data /edited by Bill Byrom and Brian Tiplady1st ed.Farnham, Surrey, England ;Burlington, VT Gowerc20101 online resource (297 p.)Description based upon print version of record.1-03-283791-8 0-566-08771-5 Includes bibliographical references and index.Cover; Contents; List of Figures; List of Tables; Foreword; About the Editors; List of Contributors; Introduction; 1 Recall Bias: Understanding and Reducing Bias in PRO Data Collection; 2 Cognitive Interviewing: The use of Cognitive Interviews to Evaluate ePRO Instruments; 3 Data Quality and Power in Clinical Trials: A Comparison of ePRO and Paper in a Randomized Trial; 4 Regulation and Compliance; 5 Selection of a Suitable ePRO Solution: Benefit, Cost and Risk; 6 Patient Compliance in an ePRO Environment; 7 Computerized Clinical Assessments8 Diary Design Considerations: Interface Issues and Patient Acceptability9 Equivalence Testing: Validation and Supporting Evidence When Using Modified PRO Instruments; 10 ePRO Applications and Personal Mobile Phone Use: Compliance Documentation and Patient Support; 11 Future Developments and Applications: Emerging Technologies and New Approaches to Patients; IndexRecently, there has been much open debate with the regulators around the use of ePRO in clinical drug submissions. US and European agencies have approved new drugs that have included ePRO data in the submission dossier, but there are many questions around the adoption of the technology that concern the community. Bill Byrom and Brian Tiplady's ePro addresses these questions, reviews the new FDA guidance, and provides a very contemporary view on this important subject.Clinical trialsData processingOutcome assessment (Medical care)Data processingClinical trialsData processing.Outcome assessment (Medical care)Data processing.610.285Byrom Bill1874494Tiplady Brian1874495MiAaPQMiAaPQMiAaPQBOOK9910964672403321EPro4485077UNINA