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Dose-finding clinical trials in oncology aim to estimate the maximumtolerated dose (MTD), based on safety traditionally obtained from theclinician's perspective. While the collection of patient-reported outcomes(PROs) has been advocated to better inform treatment tolerability, there is alack of guidance and methods on how to use PROs for dose assignments andrecommendations. The PRO continual reassessment method (PRO-CRM) has beenproposed to formally incorporate PROs to estimate the MTD, requiring completefollow-up of both clinician and patient toxicity information per dose cohort toassign the next cohort of patients. In this paper, we propose two extensions ofthe PRO-CRM, allowing continuous enrollment of patients and handling longertoxicity observation windows to capture late-onset or cumulative toxicities.The first method, the TITE-PRO-CRM, uses a weighted likelihood to include thepartial follow-up information from PRO in estimating the MTD during and at theend of the trial. The second method, the TITE-CRM+PRO, uses clinician'sinformation solely to inform dose assignments during the trial and incorporatesPRO at the end of the trial for dose recommendation. Simulation studies showthat the TITE-PRO-CRM performs similarly to the PRO-CRM in terms of doserecommendation and assignments during the trial while reducing trial duration.The TITE-CRM + PRO slightly underperforms compared to the TITE-PRO-CRM, butsimilar performance can be attained by requiring larger sample sizes. We alsoshow that the proposed methods have similar performance under higher accrualrates, different toxicity hazards, and correlated time-to-clinician toxicityand time-to-patient toxicity data.

Incorporating patient-reported outcomes in dose-finding clinical trials with continuous patient enrollment