Results from a literature review of oncology trials conducted by members of the US Food and Drug Administration indicate that more clarity and consistency is needed in the reporting of patient-reported outcomes (PROs) and quality-of-life data.1

Researchers identified 15 published manuscripts that reported PROs or health-related quality of life (HRQoL) from randomized clinical trials. Manuscripts were assigned to project team members who reviewed them using a checklist that included required items from CONSORT-PRO and additional reporting information from the FDA. CONSORT-PRO is a checklist that provides guidance for authors of trials describing patient-reported outcomes.

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Overall, the reviewers found that results for PRO and HRQoL were heterogeneous across all manuscripts.

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“A few identified issues include: shortening the y-axis length to amplify small differences between treatment arms, unclear sample size for PRO analyses and statistical summaries of the data, including missing point estimates and confidence intervals,” the researchers wrote.

These results indicate that despite the availability of CONSORT-PRO, it is applied inconsistently in trials featuring PROs. The researchers recommended that “a clearly defined research objective that uses attributes from the recently published International Council on Harmonization (ICH) estimand guideline E9(R1) addendum would help clarify who is being assessed, what is being measured, and how and what auxiliary events are being considered and in what manner.”


Merzoug L, et al. PROs in clinical trials (1096) reporting of patient-reported outcomes and quality of life data in oncology drug development trials: a literature review. Presented at: 26th Annual Conference of the International Society for Quality of Life Research; September 4, 2019. Qual Life Res. 2019;28(suppl 1):1. doi: 10.1007/s11136-019-02257-y