Abstract
The triangular test has been used to monitor survival data from a randomized trial in patients with small cell lung cancer. The results of consecutive interim analyses and the problems met by the data monitoring committee and the co-ordinators are described. The methods as well as the consequences of the early stopping on the analysis and the results of this trial are discussed. From this experience, we believe that statistical stopping rules--only one of the factors to be taken into account when deciding to stop a trial--should be used with caution. Independent data monitoring committees may be useful in helping to review the ongoing results and advise the participants in the trial.
Publication types
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Clinical Trial
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Randomized Controlled Trial
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Research Support, Non-U.S. Gov't
MeSH terms
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Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
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Carcinoma, Non-Small-Cell Lung / drug therapy*
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Carcinoma, Non-Small-Cell Lung / mortality
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Carcinoma, Non-Small-Cell Lung / radiotherapy
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Chemotherapy, Adjuvant
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Cisplatin / administration & dosage
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Cyclophosphamide / administration & dosage
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Data Interpretation, Statistical*
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Dose-Response Relationship, Drug
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Doxorubicin / administration & dosage
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Drug Administration Schedule
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Etoposide / administration & dosage
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Humans
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Lung Neoplasms / drug therapy*
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Lung Neoplasms / mortality
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Lung Neoplasms / radiotherapy
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Multicenter Studies as Topic / statistics & numerical data
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Radiotherapy, Adjuvant
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Radiotherapy, High-Energy
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Randomized Controlled Trials as Topic / statistics & numerical data*
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Survival Analysis*
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Survival Rate
Substances
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Etoposide
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Doxorubicin
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Cyclophosphamide
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Cisplatin