Outcomes research in cancer clinical trial cooperative groups: the RTOG model.
BACKGROUND
The Radiation Therapy Oncology Group (RTOG), a National Cancer Institute sponsored cancer clinical trials research cooperative, has recently formed an Outcomes Committee to assess a comprehensive array of clinical trial endpoints and factors impacting the net effect of therapy.


METHODS
To study outcomes in a consistent, comprehensive and coordinated manner, the RTOG Outcomes Committee developed a model to assess clinical, humanistic, and economic outcomes important in clinical trials.


RESULTS
This paper reviews how the RTOG incorporates outcomes research into cancer clinical trials, and demonstrates utilization of the RTOG Outcomes Model to test hypotheses related to non-small-cell lung cancer (NSCLC). In this example, the clinical component of the model indicates that the addition of chemotherapy to radiotherapy (RT) improves survival but increases the risk of toxicity. The humanistic component indicates that esophagitis is the symptom impacting quality of life the greatest and may outweigh the benefits in elderly (> or =70 years) patients. The economic component of the model indicates that accounting for quality-adjusted survival, concurrent chemoRT for the treatment of NSCLC is within the range of economically acceptable recommendations.


CONCLUSIONS
The RTOG Outcomes Model guides a comprehensive program of research that systematically measures a triad of endpoints considered important to clinical trials research.
Radiation Therapy Oncology Group, Philadelphia, PA, USA. D_Watkins-Bruner@fccc.edu
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Bruner
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Movsas
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Konski
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Roach
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Bondy
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Scarintino
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Scott
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Curran
D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy / Q000191:economics / Q000401:mortality / Q000532:radiotherapy; D002986:Clinical Trials as Topic; D003362:Cost-Benefit Analysis; D005060:Europe; D017048:Health Care Costs; D006801:Humans; D008175:Lung Neoplasms; D008962:Models, Theoretical; D009369:Neoplasms / Q000188:drug therapy / Q000191:economics / Q000401:mortality / Q000532:radiotherapy*; D017063:Outcome Assessment, Health Care / Q000191:economics / Q000379:methods*; D011788:Quality of Life; D015996:Survival Rate; D014481:United States