DTC Oncology Indication Study

The CDER Office of Prescription Drug Promotion (OPDP) is planning to conduct two studies examining presentation of oncology indications in direct-to-consumer (DTC) TV ads. A Federal Register notice says OPDP will accept comments on the studies for 60 days.

“Oncology indications are often complicated,” the notice says, “and supported by different clinical endpoints such as overall survival, overall response rate, and progression-free survival that are referenced in the DTC TV ads. The first objective of this project is to determine whether disclosing information about the nature of the endpoints that support the indications for oncology products help consumers understand the drug’s efficacy…. The second objective is to test whether consumers adequately comprehend indication statements when portions of the indication are presented only in the superimposed text of television ads while other information is included in the audio.”