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EPro : electronic solutions for patient-reported data /
Recently, 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...
| Clasificación: | Libro Electrónico |
|---|---|
| Otros Autores: | , |
| Formato: | Electrónico eBook |
| Idioma: | Inglés |
| Publicado: |
Farnham :
Gower,
2010.
|
| Temas: | |
| Acceso en línea: | Texto completo |
MARC
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| 245 | 0 | 0 | |a EPro : |b electronic solutions for patient-reported data / |c edited by Bill Byrom and Brian Tiplady. |
| 260 | |a Farnham : |b Gower, |c 2010. | ||
| 300 | |a 1 online resource (200 pages) | ||
| 336 | |a text |b txt |2 rdacontent | ||
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| 588 | 0 | |a Print version record. | |
| 505 | 0 | |a Recall bias: understanding and reducing bias in PRO data collection / Alan L. Shields, Saul Shiffman and Arthur Stone -- Cognitive interviewing: the use of cognitive interviews to evaluate ePRO instruments / Paul C. Beatty -- Data quality and power in clinical trials: a comparison of ePRO and paper in a randomized trial / Allen L. Ganser, Stephen A. Raymond and Jay D. Pearson -- Regulation and compliance: scientific and technical regulatory issues associated with electronic capture of patient-reported outcome data / Sonya Eremenco and Dennis A. Revicki -- Selection of a suitable ePRO solution: benefit, cost and risk / Mikael Palmblad -- Patient compliance in an ePRO environment: methods for consistent compliance management, measurement and reporting / Alan L. Shields, Saul Shiffman and Arthur Stone -- Computerised clinical assessments: derived complex clinical endpoints from patient self-report data / Bill Byrom, Keith Wenzel and James Pierce -- Diary design considerations: interface issues and patient acceptability / Brian Tiplady -- Equivalence testing: validation and supporting evidence when using modified PRO instruments / Damian J. McEntegart -- ePRO applications and personal mobile phone use: compliance documentation and patient support / Breffni Martin -- Future developments and applications: emerging technologies and new approaches to patients / Brian Tiplady and Bill Byrom. | |
| 504 | |a Includes bibliographical references and index. | ||
| 520 | |a Recently, 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. | ||
| 546 | |a English. | ||
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| 650 | 0 | |a Clinical trials |x Data processing. | |
| 650 | 0 | |a Information storage and retrieval systems |x Medical care. | |
| 650 | 0 | |a Medical records |x Data processing. | |
| 650 | 0 | |a Self-report inventories |x Data processing. | |
| 650 | 0 | |a Outcome assessment (Medical care) |x Data processing. | |
| 650 | 1 | 2 | |a Electrical Equipment and Supplies |
| 650 | 1 | 2 | |a Outcome Assessment, Health Care |x methods |
| 650 | 2 | 2 | |a Clinical Trials as Topic |
| 650 | 2 | 2 | |a Medical Informatics |x instrumentation |
| 650 | 6 | |a Études cliniques |x Informatique. | |
| 650 | 6 | |a Évaluation des résultats (Soins médicaux) |x Informatique. | |
| 650 | 6 | |a Dossiers médicaux |x Informatique. | |
| 650 | 6 | |a Auto-évaluation |x Tests |x Informatique. | |
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| 650 | 7 | |a Information storage and retrieval systems |x Medical care. |2 fast |0 (OCoLC)fst00972944 | |
| 650 | 7 | |a Medical records |x Data processing. |2 fast |0 (OCoLC)fst01014552 | |
| 700 | 1 | |a Byrom, Bill. | |
| 700 | 1 | |a Tiplady, Brian. | |
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