Voglio sapere a riguardo di…

lotter on DSK11XQN23PROD with NOTICES1

Federal Register / Vol. 86, No. 174 / Monday, September 13, 2021 / Notices Comment 12 One comment suggested Phase 1 and Phase 2 be converted to separate studies.
Response 12 Phase 1 and Phase 2 are intended to be two separate studies that are being examined concurrently for efficiency. We will make this distinction clear in any discussion of results.
Comment 13 One comment recommended FDA narrow the scope of the research to questions within its jurisdiction and eliminate overlap with other ongoing research.
Response 13 As explained earlier, the Public Health Service Act authorizes FDA to conduct research relating to health information, and the FD&C Act authorizes FDA to conduct research relating to drugs and other FDA
regulated products in carrying out the provisions of the FD&C Act. The study is within FDAs authority, and it will help to inform OPDPs work to help ensure that prescription drug information is truthful, balanced, and accurately communicated, so that HCPs and consumers can make informed decisions. While the comment did not identify any specific ongoing research as overlapping, we note that in general, OPDP may conduct concurrent or overlapping studies on similar topics to serve these goals.
Comment 14 One comment suggested participants be permitted to refer back to the stimuli while answering questions.
Response 14 For this study we will instruct participants to read the material carefully and alert them that they will be answering several questions about the content that they just saw. The goal of this study is not to assess participants comprehension of detailed, verbatim information in the stimuli, for which repeated exposures to study stimuli may be more appropriate.
Rather, our study will determine if experimental manipulation of the disclosure language influences gist understanding of the information, attitudes, and perceptions Ref. 8.
Allowing for multiple exposures to the stimuli could potentially influence these outcomes. A large body of literature supports presence of a mere exposure effects in social science research, where more exposure enhances processing and increases positive affect towards stimuli Refs. 9
and 10.
Comment 15 One comment stated the research lacks practical utility because it treats the secondary benefit claim as not related to the products indicated uses, and the comment recommends that FDA revise Phase 1 of the study to reflect that secondary endpoints are not inherently
VerDate Sep<11>2014

17:39 Sep 10, 2021

Jkt 253001

unapproved uses and to focus instead on comprehension of what is a primary versus secondary endpoint in the data supporting a drugs approval.
Response 15 In this study, we are not making a generalization about the approval status of secondary endpoints.
We are examining the specific case of a disclosure about a secondary endpoint that, while it may be related to the products primary indication, is not in itself an indication for the product and was not evaluated in such a way to support the drawing of conclusions about the products effect on that endpoint. In this scenario, a disclosure about the secondary claim may help the audience interpret the secondary claim and provide context. The purpose of this study is to evaluate such disclosures about this specific type of secondary claim and measure the impact on perceptions of and attitudes toward the product, the secondary claim, and the disclosure. For instance, we will vary such elements as the presence of quantitative information about the secondary claim and the presence of comparative information see table 1 for full design. We note that there are examples of prescription drug ads currently in use that contain language similar to what we are evaluating in order to qualify secondary endpoints, thus highlighting the practical utility of this research.
Comment 16 One comment suggested changes to the instructions for Phase 2 to state that the study is intended to assess your understanding of and reactions to biosimilar biologic drug disclosures.
Response 16 The control condition does not identify the product as biosimilar. To maintain the internal validity of the study and avoid potentially biasing participants responses, we will keep the instructions as they are.
Comment 17 One comment suggested changing the dosage route and strength of the reference product to be consistent with currently marketed biologics.
Response 17 We have made this change.
Comment 18 Two comments asked that the name of the reference product be changed to one that is fictitious.
Response 18 We have made this change and will use a fictitious reference product name.
Comment 19 One comment suggested stratifying the sample on several variables. The comment suggested that obesity and diabetes diagnosis be considered specifically for Phase 1, as well as variables like disease severity, treatment history e.g., patients
PO 00000

Frm 00021

Fmt 4703

Sfmt 4703

50891

who have never received a biologic versus biologic-experienced patients, and knowledge of the studied condition for both phases.
Response 19 Typically, stratified randomization is used if there are prognostic variables that correlate with outcome measures and researchers are concerned about such factors not being evenly distributed across groups Ref.
11. We have no reason to believe that we will not achieve adequate balance of prognostic variables given the large sample size proposed for this study Ref.
11. Random assignment will help to produce groups that are, on average, probabilistically similar to each other.
Because randomization eliminates most other sources of systematic variation, we can be reasonably confident that any effect that is found is the result of the intervention and not some preexisting differences between the groups Ref. 12.
Our survey includes several questions about health and medical demographics that will enable us to assess their association with our outcomes and statistically control for them if necessary.
Comment 20 One comment suggested using consistent scales throughout the study and adding based on the ad you just saw to many of the questions.
Response 20 As suggested, we have added statements in the instructions for respondents to answer based on the promotion they just saw for clarification. Where possible, we have used validated measures and have retained the scale endpoints of those measures. We do not believe that these varied types of questions will pose difficulties for respondents as we did not find evidence of difficulties in cognitive testing.
Comment 21 One comment suggested deleting or revising Phase 1
Questions 4 to 7 to focus on whether the participant understands that the secondary use is linked to the approved primary indication.
Response 21 Our collection of constructs and measures, grounded in behavioral theory Refs. 1 to 3, assesses perceptions, attitudes, understanding, and intentions around prescription drug disclosures. Based on cognitive testing, we have removed these questions.
Comment 22 One comment suggested deleting Phase 1 Questions 9, 15, and 16 because they deal with the practice of medicine.
Response 22 The intent of Question 9 is to assess understanding of the secondary claim disclosure, which explains that even though the drug is not indicated for weight loss, that it can help some people lose weight. Based on
E:FRFM13SEN1.SGM

13SEN1