Lilly Suggests FDA Drug Communication Research Changes

Lilly says that the research objectives and study approach for an FDA study of character-space-limited online prescription drug communication generally seem reasonable. The research is to examine two hypotheses, it says in a comment letter. The first is that participants who see substantive risk information in character-space-limited communication, compared with link-only participants, will have greater retention of the risk included in the communication and higher perceived risk. The second hypothesis is that participants with a “search goal” compared with a “browse goal” will have greater retention of the benefit and risk information and higher perceived risk because they will be more likely to notice the character-space-limited communication and to link to the risk information.

The company offers several suggested improvements to the study questionnaire and study design.