FDA1081735_MockCopyTest.pdf

Attachment 1: Mock Copy Test

A.1.1. Instructions - Offerors shall respond to questions under 1, 2, and 3, including completing Tables 1-3. The first question will count as 20 points, the second question will count as 50 points, and the third question will count as 30 points, for a cumulative score of 100 points.

A.1.2. Description of hypothetical copy test

A.1.2.1. This is a simplified example of the type of copy tests FDA requires. For the purpose of this exercise, there are fewer participants, only one open-ended question, and fewer analyses to conduct than will be expected in an actual copy test.

A.1.2.2. An ad for Drug X (a hormone therapy) claims that the drug is natural and that it is the #1 prescribed drug of its kind. We want to test whether these claims imply that the drug is safe and/or effective. To do so, we randomly assigned participants to view one of three versions of the ad: (1) the original ad, which includes both claims; (2) a version of the original ad with the “natural” claim deleted; and (3) a version of the original ad with the “#1 prescribed” claim deleted. The target population is women 45-65 years of age.

A.1.3. Calculate the response rate and cooperation rate, given the following information:

400 Completed surveys 18 Partial surveys (not considered sufficient for a completed survey) 37 Refusals 12 Contacted but not eligible 0 Not contacted but eligible 796 Unknown eligibility 6 Other (eligible but did not complete the survey for reasons other than refusal)

1a. What is the response rate? _____________________ Include the equation used. ____________________

1b. What is the cooperation rate? ___________________ Include the equation used. ____________________

A.1.4. Analyze the mock dataset, including:

2a. Report frequencies and percents of demographic characteristics (gender, age, race, ethnicity, education). Complete Table 1.

2b. Identify any outliers (defined as 3 standard deviations above or below the mean) on total time taken to complete the survey (variable name = totaltime). If any outliers are identified, remove them from the remainder of the analyses.

2b.1. How many outliers were identified? _____________________

2c. There is one open-ended question in the dataset (variable name = adsay). Code the open-ended responses into the following categories (0 = no mention, 1 = any mention):

Risky: any mention of the drug being risky, including mentions of risks or side effects Safe: any mention of the drug being safe

Natural: any mention of the drug being natural Number one: any mention of the drug being number one.

Superior: any mention of the drug being superior to other drugs (e.g., more effective, safer);

this does not include mentioning that the drug is “#1.”

Codes are not mutually exclusive; for example, a statement such as “this drug is safer than others” would receive a code of “1” for the Safe category and “1” for the Superior category.

2c.1. What are the frequencies and percents for each category? Complete Table 2.

2d. Using analysis of variance (ANOVA), test whether condition (variable name = condition) affected perceived efficacy (variable name = workwell) and perceived risk (variable name = risk). Specifically, test whether there were differences between the original ad (value label = original ad) and the ad with the #1 claim deleted (value label = no #1 claim), and whether there were differences between the original ad (value label = original ad) and the ad with the natural claim deleted (value label = no natural claim). For the purpose of this exercise, please act as if all the assumptions of ANOVA have been met (e.g.

normality). Report the means, standard deviations, test statistics, and p-values in Table 3.

2e. Repeat the analyses in 2d with age and ethnicity included in the model as covariates. Report the test statistics and p-values in Table 3.

A.1.5. Provide a brief write-up of the analyses conducted and results (from sections 1 and 2 above) in APA (American Psychological Association) style (http://www.apastyle.org/).

Clarity and organization of the write-up (including grammar, punctuation, and spelling) are important.

A.1.6. Tables

A.1.6.1. Table 1: Demographic Characteristics A.1.6.2. Table 2: Coded Responses to “What does this ad say or suggest about this product?”

A.1.6.3. Table 3: Raw Mean (standard deviation) perceived efficacy and perceived risk by condition.

[Space intentionally left blank for formatting] http://www.apastyle.org/

Table 1. Demographic characteristics (n = ___) Characteristics Number Percent

Gender Male Female Ethnicity Hispanic or Latino Not Hispanic or Latino Race American Indian or Alaska Native Asian Black or African American Native Hawaiian or Pacific Islander White Other Multi-racial Prefer not to answer Education Some high school Completed high school Some college Completed college Graduate school or more

Mean (Standard Deviation)

Range Age

Table 2. Coded responses to “What does this ad say or suggest about this product?” (n = ___)

Category Frequency Percent Risky Safe Natural Number One Superior

Table 3. Raw Mean (Standard Deviation) perceived efficacy and perceived risk by condition.

Ad Condition

ANOVA Test Statistic

ANCOVA Test Statistic

(1) vs.

(2)

(1) vs.

(3)

(1) vs. (2) (1) vs. (3)

Dependent Variable

(1) Original

(2) No #1 Claims

(3) No Natural Claims

F(__,__), F(__,__), F(__,__), F(__,__), p-value p-value p-value p-value Perceived Efficacy

Perceived Risk