Voglio sapere a riguardo di…

lotter on DSK11XQN23PROD with NOTICES1

50892

Federal Register / Vol. 86, No. 174 / Monday, September 13, 2021 / Notices
cognitive testing, we have revised the question to more specifically assess potential misperceptions of the claim;
drug name is for weight loss Questions 15 and 16 are intended to assess perceptions about the magnitude of the drugs benefitwith regard to both the indication reduction in A1C
levels and the secondary claim weight lossbased on the information in the website. Based on cognitive testing, we have revised these questions to read How much do you think drug name would lower A1C levels for patients with type 2 diabetes? and How much do you think drug name would help with weight loss for patients with type 2 diabetes? It is a proper subject for FDA research to study whether particular framing of statements contributes to an HCPs accurate understanding or to misunderstanding about drugs to inform their prescribing decisions in the course of their practice of medicine.
Comment 23 One comment suggested deleting or clarifying Phase 1
Question 11 to refer to type 1 or type 2 diabetes rather than other health conditions. This comment also suggested revising Phase 1 Questions 12
to 16 to indicate they are focused on diabetic patients.
Response 23 We have deleted Question 11 and have revised the other items to refer specifically to type 2
diabetes to improve question clarity.
Comment 24 One comment suggested deleting or revising Phase 1
Question 10 to read Drug X is approved for helping people without diabetes lose weight.
Response 24 We have deleted this question.
Comment 25 One comment recommended deleting Phase 1
Questions 17 to 23 and Questions 35 to 38 because responses could be influenced by many reasons and it is unclear how these questions relate to the study objectives.
Response 25 These items measure perceived efficacy and attitude toward the drug. Attitude toward the drug and perceived efficacy can influence other outcomes such as the intention to take the drug or mention it to the doctor.
Thus, we believe it is important to assess these variables. Given that we are randomizing participants to experimental conditions, we suspect that differences between experimental conditions are due to the experimental manipulations rather than participants background and experiences.
Additionally, we also included several variables to measure participants experience with diabetes and weight loss, as well as medications for these
VerDate Sep<11>2014

17:39 Sep 10, 2021

Jkt 253001

conditions. If these variables are related to perceived efficacy and attitude toward the drug, we plan to include them as covariates in analyses.
Comment 26 One comment suggested deleting Phase 1 Questions 32
to 34 because these questions ask about perceived risks and side effects that are not within the stated study objectives.
Response 26 The goal of the study is to examine the impact of the presence of the comparative claim and type of disclosures; it is possible for participants to form different and potentially distorted risk perceptions based on the presence or absence of the comparative claim or type of disclosure.
Assessing this outcome will allow us to determine whether risk perceptions vary based on exposure to study manipulations.
Comment 27 One comment suggested deleting or revising Phase 2
Questions 4 to 11 and Questions 14 to 18 because participants will not be able to evaluate the safety and efficacy of, or make decisions about, their intended course of action related to the fictitious drug.
Response 27 The promotional material will include information on primary and secondary endpoints as well as an important safety information section. We acknowledge that in a clinical setting patients and HCPs may use additional information. However, the intent of these items is to understand whether exposure to different types of information related to the comparative claim and disclosure results in different comprehension or behavioral intention. All participants will have the same level of information regarding the fictitious drug with the only difference being the manipulated content. So, we would expect that all participants will be equally informed about the fictitious drug and differences between conditions could be attributed to the manipulations. Items 4 to 11
assess participant comprehension of promotional material.
Comment 28 One comment suggested deleting all Phase 2 questions about the advertising statement, questions assessing participants understanding of how prescription drugs and biologic products work, familiarity with similar treatments, and attitudes about pharmaceutical companies; in particular, Questions 3, 27 to 30, and 36.
Response 28 The answers to these questions may help contextualize differences between the experimental conditions. There is some evidence that prior attitudes toward prescription drugs and pharmaceutical companies have an impact on attitudes and
PO 00000

Frm 00022

Fmt 4703

Sfmt 4703

perceptions of particular prescription drugs and DTC ads Ref. 13. Question 3 assesses attitudes toward the disclosure. For instance, it is possible that participants exposed to a certain disclosure may have more favorable attitudes towards the drug because they viewed the disclosure as trustworthy.
Questions 27 to 30 and 36 will also help us contextualize the findings by understanding participants prior beliefs about prescription drugs, biosimilars, and pharmaceutical companies that may influence their responses and how they process the disclosure, in which case we would include them as controls in our analyses.
Comment 29 One comment suggested moving Phase 2 Questions 27
to 38 to the beginning of the questionnaire, before the participant views the stimuli.
Response 29 These questions are included to contextualize the findings and obtain an understanding of participants prior beliefs and perceptions about biosimilars and more broadly prescription drug promotion.
We ask these questions after the main study outcomes are assessed so that we do not contaminate participants thoughts and perceptions of the promotional material. In addition, we do not want to prime the participants in the control condition who are not told the drug is a biosimilar to think the drug is a biosimilar, which would be equivalent to one of the other study conditions.
Comment 30 One comment suggested adding a response option to capture a neutral or no reaction response to questions.
Response 30 There are benefits and drawbacks to including a neutral or no reaction response in survey research, and the decision to use a neutral midpoint depends on the goal of the measures. For items assessing comprehension of disclosure language, we include a do not know option as this response would indicate some level of uncertainty about the meaning of the disclosure, which is meaningful and actionable information. However, when assessing perceptions and attitudes towards disclosures, our objective is to force a selection and have participants choose a leaning towards agreement or disagreement with the statement.
Inclusion of a neutral response option in these instances could potentially encourage satisficingcuing participants to select a neutral response under uncertainty because it is offered Ref. 14.
Comment 31 One comment suggested clarifying Phase 2 Question 28 to make clear it refers to the
E:FRFM13SEN1.SGM

13SEN1