Improving the Capture of Adverse Event Data in Clinical Trials: The Role of the International Atomic Energy Agency

• Published in: International journal of radiation oncology, biology, physics Vol. 69; no. 4; pp. 1218 - 1221
• Main Authors: Davidson, Susan E., M.D, Trotti, Andy, M.D, Ataman, Özlem U., M.D., Ph.D, Seong, Jinsil, M.D., Ph.D, Lau, Fen Nee, M.D, da Motta, Neiro W., M.D., Ph.D, Jeremic, Branislav, M.D., Ph.D
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 15.11.2007
• Subjects: Adverse events reporting; BRACHYTHERAPY; CLINICAL TRIALS; Clinical Trials as Topic - standards; Colorado; CTCAE; Data Collection - methods; Data Collection - standards; DOSE RATES; Drug-Related Side Effects and Adverse Reactions; Hematology, Oncology and Palliative Medicine; Humans; IAEA; International Agencies; National Cancer Institute (U.S.) - standards; NEOPLASMS; Nuclear Energy; Observer Variation; RADIOBIOLOGY; Radiology; RADIOLOGY AND NUCLEAR MEDICINE; Radiotherapy - adverse effects; Surveys and Questionnaires - standards; Terminology as Topic; TOXICITY; United States; United States; Colorado; CTCAE; Adverse events reporting
• ISSN: 0360-3016; 1879-355X
• DOI: 10.1016/j.ijrobp.2007.04.054

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.