LEADER 03399nam  2200673Ia 450 
001 9910459535203321
005 20200520144314.0
010   $a1-317-14191-1
010   $a1-317-14190-3
010   $a1-282-85767-3
010   $a9786612857676
010   $a1-4094-1242-3
035   $a(CKB)2670000000048227
035   $a(EBL)592377
035   $a(OCoLC)679416674
035   $a(SSID)ssj0000436024
035   $a(PQKBManifestationID)12127384
035   $a(PQKBTitleCode)TC0000436024
035   $a(PQKBWorkID)10426074
035   $a(PQKB)11774953
035   $a(MiAaPQ)EBC592377
035   $a(MiAaPQ)EBC5293633
035   $a(Au-PeEL)EBL592377
035   $a(CaPaEBR)ebr10421628
035   $a(CaONFJC)MIL922612
035   $a(Au-PeEL)EBL5293633
035   $a(CaONFJC)MIL285767
035   $a(OCoLC)1027177913
035   $a(EXLCZ)992670000000048227
100   $a20100907d2010      uy             0
101 0 $aeng
135   $aur|n|---|||||
181   $ctxt
182   $cc
183   $acr
200 00$aePro$b[electronic resource] $eelectronic solutions for patient-reported data /$fedited by Bill Byrom and Brian Tiplady
210   $aFarnham, Surrey, England ;$aBurlington, VT $cGower$dc2010
215   $a1 online resource (297 p.)
300   $aDescription based upon print version of record.
311   $a0-566-08771-5 
320   $aIncludes bibliographical references and index.
327   $aCover; 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 Assessments
327   $a8 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; Index
330   $aRecently, 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.
606   $aClinical trials$xData processing
606   $aOutcome assessment (Medical care)$xData processing
608   $aElectronic books.
615  0$aClinical trials$xData processing.
615  0$aOutcome assessment (Medical care)$xData processing.
676   $a610.285
701   $aByrom$b Bill$0891020
701   $aTiplady$b Brian$0891021
801  0$bMiAaPQ
801  1$bMiAaPQ
801  2$bMiAaPQ
906   $aBOOK
912   $a9910459535203321
996   $aEPro$91990285
997   $aUNINA