Improving the Capture of Adverse Event Data in Clinical Trials: The Role of the International Atomic Energy Agency
Received 13 February 2007; received in revised form 25 April 2007; accepted 29 April 2007. published online 07 August 2007.
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.
∗Department of Clinical Oncology, Christie Hospital NHS Trust, Manchester, United Kingdom
†Division of Radiation Oncology, H. Lee Moffitt Cancer Center, University of South Florida, Tampa, FL
‡Dokuz Eylul University Oncology Institute, Izmir, Turkey
§Department of Radiation Oncology, Yonsei Cancer Center, Yonsei University Medical College, Seoul, South Korea
‖Institute of Radiotherapy and Oncology, Hospital Kuala Lumpur, Kuala Lumpur, Malaysia
¶Fundaçao Faculdade Federal de Ciencias Medicas de Porto Alegre, Servico de Radioterapia, Porto Alegre, Brazil
#International Atomic Energy Agency, Vienna, Austria
Reprint requests to: Susan E. Davidson, M.D., Department of Clinical Oncology, Christie Hospital NHS Trust, Wilmslow Road, Manchester M20 4BX, United Kingdom. Tel: (+44) 161-446-3410; Fax: (+44) 161-44-8014
The International Atomic Energy Agency (IAEA) Consultant's meeting was held October 15, 2005, Denver, CO. The IAEA provided financial support for this meeting.
ABSTRACT