TRIANGULAR TEST AND RANDOMIZED TRIALS - PRACTICAL PROBLEMS IN A SMALLLUNG-CANCER TRIAL

The triangular test has been used to monitor survival data from a rand omized trial in patients with small cell lung cancer. The results of c onsecutive interim analyses and the problems met by the data monitorin g committee and the co-ordinators are described. The methods as well a s the consequences of the early stopping on the analysis and the resul ts 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. I ndependent data monitoring committees may be useful in helping to revi ew the ongoing results and advise the participants in the trial.