Do the Challenges With Assessment of PROs in Oncology Trials Really Outweigh the Benefit?

PURPOSE:

Whereas patient-reported outcomes (PROs) are seldom included in early phase oncology studies and are often included in later phase studies, the measurement, and data capture strategy of PROs in oncology clinical trials has frequently come under criticism. This workshop will examine the challenges associated with the assessment of PROs throughout oncology drug development, and taking account of recent guidance from regulators, will also provide workable solutions.

DESCRIPTION:

Workshop attendees will gain a working knowledge of the benefits of using PROs across oncology drug development programs. Drs. Byrom, Sen and Gnanasakthy will explore approaches to assessing tolerability and aiding optimal dose selection with newer targeted therapies in cancer drug development, particularly in early phase studies. Through case studies, they will illustrate the increasing importance of PRO data in better characterizing the dose-tolerability relationship during the early development phase of oncology drug development. Inviting audience contributions, they will discuss pragmatic approaches to collecting symptomatic PRO data in early phase studies, especially where there is little prior knowledge of the treatment's side effect profile.

For later phase studies, exploring the implementation of the FDA draft guidance on core PRO measures in cancer trials, Drs. Byrom, Sen and Gnanasakthy will examine unanswered questions crucial to the success of this approach. Inviting audience commentary, they will debate whether implementing subscales of larger measures independently might alter the context of question administration and affect the measurement properties of the standalone subscales. Using published examples, the audience will be invited to provide their views on the impact of subscale context. Finally, they will examine the possible burden on patients of more frequent at-home PROM assessments—what data do we have to evaluate the impact of more frequent assessments, and what gaps remain in our understanding of what drives unrealistic burden?