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.
Latest Forms, Documents, and Supporting Material
All Historical Document Collections
| Reference | Filing | Received | Concluded | Action |
|---|---|---|---|---|
| 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