OMB control number

Study of Oncology Indications in Direct-to-Consumer Television Advertising

OMB 0910-0885 · HHS/FDA.

OMB 0910-0885

This study will examine how oncology prescription drug indications are communicated to consumers in direct-to-consumer (DTC) promotional materials. We plan to conduct two rounds of in-person one-hour cognitive interviews (N = 9 in each), two pretests (N = 60 in each), and two main studies (N = 700 in Study 1; N = 520 in Study 2) not longer than 20 minutes, administered via Internet panel. In the first cognitive interview, pretest, and main study, we will vary the indication (hematology or solid tumor), the clinical endpoint (overall survival, overall response rate, or progression-free survival), and the presence of a disclosure in a television ad for a fictitious oncology prescription drug. In the second cognitive interview, pretest, and main study, we will vary the indication (hematology or solid tumor) and the presentation of material information in audio and superimposed text in a television ad for a fictitious oncology prescription drug. In each study, participants will view the television ad and then answer questions about the drug information.

The latest form for Study of Oncology Indications in Direct-to-Consumer Television Advertising expires 2023-02-28 and is listed under ICR 202007-0910-004.

All Historical Document Collections

Historical document collections
ReferenceFilingReceivedConcludedAction
202104-0910-001 No material or nonsubstantive change to a currently approved collection 2021-04-05 Approved with change
202007-0910-004 No material or nonsubstantive change to a currently approved collection 2020-07-08 Approved with change
202001-0910-013 New collection (Request for a new OMB Control Number) 2020-01-29 Approved with change

OMB Details

Cognitive Interview Screener

Federal Enterprise Architecture: Health - Consumer Health and Safety