Improving the capture of adverse event data in clinical trials: the role of the International Atomic Energy Agency.

2.50
Hdl Handle:
http://hdl.handle.net/10541/71159
Title:
Improving the capture of adverse event data in clinical trials: the role of the International Atomic Energy Agency.
Authors:
Davidson, Susan E; Trotti, Andy; Ataman, Ozlem U; Seong, Jinsil; Lau, Fen Nee; da Motta, Neiro W; Jeremic, Branislav
Abstract:
PURPOSE: 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.
Affiliation:
Department of Clinical Oncology, Christie Hospital NHS Trust, Manchester, United Kingdom. Susan.Davidson@christie-tr.nwest.nhs.uk
Citation:
Improving 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.
Journal:
International Journal of Radiation Oncology, Biology, Physics
Issue Date:
15-Nov-2007
URI:
http://hdl.handle.net/10541/71159
DOI:
10.1016/j.ijrobp.2007.04.054
PubMed ID:
17689027
Type:
Article
Language:
en
ISSN:
0360-3016
Appears in Collections:
All Christie Publications

Full metadata record

DC FieldValue Language
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.en
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

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