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Over the past two to three decades, NCI has collected Quality of Life (QOL) data from patients on our clinical trials. Early efforts allowed us to understand that we could indeed collect this data and use that data to provide descriptive information. We have evolved from merely collecting the descriptive data to the need to see a reason for that data (the hypothesis generated inclusion of the HRQOL or PROs). However, just the inclusion of the hypothesis or rationale for collecting PRO/HRQOL data has not led to integration of that information into the overall treatment effect. In some cases, the PRO endpoints could provide important input into the assessment of efficacy (reduction of disease specific symptoms) or the assessment of toxicity (better capture of the symptomatic toxicities).

With the dual issues of reduced resources coupled with the increasing demand for a variety of endpoints to be included in NCI Clinical Trials, we now need to set a framework for the inclusion of HRQOL and PROs in NCI Clinical Trials. This framework will be designed as a guide to delineate the key priorities for the inclusion of PRO and HRQOL information and thus, guide our investigators, Disease and Modality Steering Committee members and internal NCI staff.  While this framework will be developed for NCI trials, we should be mindful and include language about the FDA guidance for PROs in a labeling indication as well as their qualification process. This does not need to be our primary focus, but if an NCI trial is being designed under an IND or NDA, then we need to at least point to the FDA for their input/etc.



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