A 15 Year Review (2006-2020) of Patient-Reported Outcomes (PRO) in United States Oncology Product Labeling and Trends in Sponsor Size and Oncology Experience

Abstract BackgroundDespite wide use of patient reported outcomes (PRO) tools in clinical development, resulting data is rarely incorporated into the US label. This study reviewed oncology product labels approved by the Food and Drug Administration (FDA) between 2006 and 2020 to determine if the rate of PRO inclusion in labeling has meaningfully changed. Sponsors were assessed to identify demographic trends in achieving PRO label success. MethodsFDA-approved drugs were searched utilizing the Drugs@FDA database by month from January 2006 to December 2020 for novel drug and biologic approvals. Labels and product summary basis of approval (SBA) were reviewed for inclusion of PRO data. Sponsor size and experience were determined for each product in the year of initial approval. Results155 oncology products received initial approval between 2006-2020, of which only 7 contained PRO data in the label. More than half (53.5%) of products had PRO data described in the SBA. Over time, PRO information increasingly been included in the product marketing application. Sponsors utilizing PRO data tend to be experienced in oncology development and larger in size. ConclusionsThere has been no meaningful change in inclusion of PRO data in oncology product labeling over the past 15 years. Recent FDA guidance and initiatives may provide additional clarification to support appropriate PRO tools to support label inclusion as well as another forum for distributing PRO data publicly.