Optimal COA Measurement Strategy In Modern Oncology Trials

Since the FDA released preliminary instructions concerning the incorporation of patient-reported outcome measures (PROMs) in contemporary oncology investigations, Signant's internal specialists have compiled essential insights regarding the latest initiatives. In this whitepaper, the authors also provide crucial factors to contemplate for achieving an ideal Clinical Outcome Assessment (COA) measurement strategy. This encompasses the accurate selection, execution, and management of PROMs.

Within these pages, readers will grasp the fundamental domains that hold paramount significance to the regulatory agency during their evaluation of oncology PROM data. Furthermore, guidance will be offered on deriving optimal endpoints to substantiate regulatory choices and labeling decisions. Additionally, the text will offer recommendations for maintaining a balance between the frequency of PROM administration and the potential burden imposed on patients.

For more detailed information, download the document below.