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Fig. 1 | BMC Medical Research Methodology

Fig. 1

From: Practicalities in running early-phase trials using the time-to-event continual reassessment method (TiTE-CRM) for interventions with long toxicity periods using two radiotherapy oncology trials as examples

Fig. 1

Graphic illustration of the TiTECRM method. The first plot shows the recruited participants over time. We illustrate the observation window T for each recruit; y3 has experienced a toxicity hence omitting presenting the full observation window. The dose allocated for participant 5, at the current time point, is decided by accounting for all of the available data, which includes the toxicity status and weights of participants 1–4. These will be accounted for in the calculation of the updated dose-toxicity curve. The table shows the weight that each participant contributes in updating the dose-toxicity curve when participant 5 is recruited onto the trial. Although participant 3 has not completed the observation window, they have experienced a toxicity event, so their contributed weight to the model is 1. The second plot presents the dose allocation for each participant. In this scenario, once a toxicity is observed, the model recommends de-escalating to dose level 2. As participant 4 was not on the trial for long when participant 5 was recruited, the model recommends the same dose for participant 5. This figure reflects the example code and (fictitious) data presented in the Additional file 1

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BMC Medical Research Methodology

ISSN: 1471-2288

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