Show simple item record

dc.contributor.authorDavidson, Susan E
dc.contributor.authorTrotti, Andy
dc.contributor.authorAtaman, Ozlem U
dc.contributor.authorSeong, Jinsil
dc.contributor.authorLau, Fen Nee
dc.contributor.authorda Motta, Neiro W
dc.contributor.authorJeremic, Branislav
dc.date.accessioned2009-06-22T13:25:49Z
dc.date.available2009-06-22T13:25:49Z
dc.date.issued2007-11-15
dc.identifier.citationImproving the capture of adverse event data in clinical trials: the role of the International Atomic Energy Agency. 2007, 69 (4):1218-21 Int. J. Radiat. Oncol. Biol. Phys.en
dc.identifier.issn0360-3016
dc.identifier.pmid17689027
dc.identifier.doi10.1016/j.ijrobp.2007.04.054
dc.identifier.urihttp://hdl.handle.net/10541/71159
dc.description.abstractPURPOSE: To report meetings of the Applied Radiation Biology and Radiotherapy section of the International Atomic Energy Agency (IAEA), organized to discuss issues surrounding, and develop initiatives to improve, the recording of adverse events (AE) in clinical trials. METHODS AND MATERIALS: A first meeting was held in Atlanta, GA (October 2004). A second meeting was held in Denver, CO (October 2005) and focused on AE data capture. The National Cancer Institute Common Terminology Criteria for Adverse Events, version 3 (CTCAE) was suggested during the first meeting as the preferred common platform for the collection and reporting of AE data in its clinical trials. The second meeting identified and reviewed the current weaknesses and variations in the capture of AE data, and proposals to improve the quality and consistency of data capture were discussed. RESULTS: There is heterogeneity in the collection of AE data between both institutions and individual clinicians. The use of multiple scoring systems hampers comparisons of treatment outcomes between centers and trials. There is often insufficient detail on normal tissue treatment effects, which leads to an underestimate of toxicity. Implementation of improved data capture was suggested for one of the ongoing IAEA clinical trials. CONCLUSIONS: There is a need to compare the quality and completeness of data between institutions and the efficacy of structured/directed vs. traditional passive data collection. Data collection using the CTCAE (with or without a questionnaire) will be investigated in an IAEA multinational trial of radiochemotherapy and high-dose-rate brachytherapy in cervical cancer.
dc.language.isoenen
dc.subject.meshClinical Trials as Topic
dc.subject.meshColorado
dc.subject.meshData Collection
dc.subject.meshDrug Therapy
dc.subject.meshHumans
dc.subject.meshInternational Agencies
dc.subject.meshNational Cancer Institute (U.S.)
dc.subject.meshNuclear Energy
dc.subject.meshObserver Variation
dc.subject.meshQuestionnaires
dc.subject.meshRadiotherapy
dc.subject.meshTerminology as Topic
dc.subject.meshUnited States
dc.titleImproving the capture of adverse event data in clinical trials: the role of the International Atomic Energy Agency.en
dc.typeArticleen
dc.contributor.departmentDepartment of Clinical Oncology, Christie Hospital NHS Trust, Manchester, United Kingdom. Susan.Davidson@christie-tr.nwest.nhs.uken
dc.identifier.journalInternational Journal of Radiation Oncology, Biology, Physicsen
html.description.abstractPURPOSE: To report meetings of the Applied Radiation Biology and Radiotherapy section of the International Atomic Energy Agency (IAEA), organized to discuss issues surrounding, and develop initiatives to improve, the recording of adverse events (AE) in clinical trials. METHODS AND MATERIALS: A first meeting was held in Atlanta, GA (October 2004). A second meeting was held in Denver, CO (October 2005) and focused on AE data capture. The National Cancer Institute Common Terminology Criteria for Adverse Events, version 3 (CTCAE) was suggested during the first meeting as the preferred common platform for the collection and reporting of AE data in its clinical trials. The second meeting identified and reviewed the current weaknesses and variations in the capture of AE data, and proposals to improve the quality and consistency of data capture were discussed. RESULTS: There is heterogeneity in the collection of AE data between both institutions and individual clinicians. The use of multiple scoring systems hampers comparisons of treatment outcomes between centers and trials. There is often insufficient detail on normal tissue treatment effects, which leads to an underestimate of toxicity. Implementation of improved data capture was suggested for one of the ongoing IAEA clinical trials. CONCLUSIONS: There is a need to compare the quality and completeness of data between institutions and the efficacy of structured/directed vs. traditional passive data collection. Data collection using the CTCAE (with or without a questionnaire) will be investigated in an IAEA multinational trial of radiochemotherapy and high-dose-rate brachytherapy in cervical cancer.


Files in this item

This item appears in the following Collection(s)

Show simple item record