OMB Generic ICR Request

FDA DOCUMENTATION FOR THE GENERIC CLEARANCE,

“Testing Communications on Drugs”
(0910-0695)

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TITLE OF INFORMATION COLLECTION: Rapid Message Testing with Consumer Panel—Clinical Trials Brochure

DESCRIPTION OF THIS SPECIFIC COLLECTION

1. Statement of need:

The purpose of this project is to conduct timely message testing of an FDA communication that encourages people to become a clinical trial research volunteer. Historically, the elderly, women (in some therapeutic areas), and racial/ethnic minorities have been underrepresented in clinical trials. In response to this concern, Congress included Section 907 in the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012, giving FDA direction to evaluate this issue and take action. FDA has responded in multiple ways, including a multi-media campaign highlighting the importance of clinical trial participation. The trifold brochure that FDA plans to test is part of this campaign, and it is designed to urge those underrepresented in clinical trials to find out more information and consider enrolling.

Communications science tells us that we must test messages with our intended audiences before communicating them. Thus, FDA plans to test this communication using online cognitive interviews with a small sample of 15 U.S. adults drawn from a diverse consumer panel.

This data collection is the first in a series of FDA rapid message testing projects. These projects are part of FDA’s effort to make consumer testing part of its routine communication development processes. In June 2016, OMB agreed to FDA flagging these projects for immediate OMB attention that reduces even the shortened generic clearance timeline.

This project is in keeping with the spirit of the 2015 Executive Order to improve how information is presented to consumers by applying behavioral science insights, and it meets repeated calls from FDA’s Risk Communication and Advisory Committee to conduct message testing with targeted samples of the general public.

2. Intended use of information:

FDA’s contractor Westat will test the clinical trials brochure with a small sample of target audience members to ensure the message meets its objectives without causing unintended negative effects. FDA will use the collected interview data to refine its messaging by improving the comprehensibility, enhancing the cultural appropriateness and sensitivity, and improving the personal relevance for a higher public health impact.

The data collected will not be statistically representative of the target audience population. Therefore, the data will not be used for making policy or regulatory decisions.

3. Description of respondents:

We will conduct 15 45-minute interviews with U.S. adults. Westat has partnered with Research Now Group, Inc., a global leader in digital data collection, to recruit respondents from its general population research panel and avoid “professional” panelists through proprietary recruitment and enrollment techniques.

We will use a participant screener to only recruit adults who have never participated in a clinical trial. To help ensure the brochure is understandable to those with lower health literacy, we will only recruit those with a high school education or less. To account for populations underrepresented in clinical trials, we will test the brochure with an oversampling of women and those aged 75 and older. We will test the brochure exclusively with racial/ethnic minorities, including an oversampling of African Americans and Hispanics. In addition, one third of the interviews (5 interviews) will be conducted in Spanish with Spanish-only speakers using a Spanish version of the brochure. The participant pool will be regionally diverse, and the Spanish-only speakers will also be diverse in terms of their country of origin. We will also try to recruit participants with health conditions that disproportionately impact minority populations (e.g., diabetes, sickle-cell anemia), although health condition will not be used as an eligibility requirement.

4. Date(s) to be Conducted:

We plan to conduct interviews in July/August 2017.

5. How the Information is being collected:

We will conduct all interviews remotely using telephone and screen sharing technology with participants on web-enabled devices such as desktop computers, laptops, tablets or mobile phones. We will ensure that any materials provided to the participants for the test are compatible with all devices. We will also send participants a hard copy of the brochure by postal mail so they can see the communication in its intended form as a trifold brochure.

For each 45-minute interview, a trained interviewer will lead the discussion using a semi-structured interview guide that ensures consistency in major topics but allows flexibility in probing each participant on particular questions. A trained interviewer fluent in Spanish will lead the discussion with Spanish speaking participants.

Note takers will chart their findings into a standardized reporting template so that all notes are organized in a consistent manner. With the consent of participants, we will audio record each interview. Although the notes will be taken in real time and the majority of the details captured during the interview session itself, note takers will consult the interview recording for any information they feel they may have missed or not captured completely during the interview session.

FDA staff will have the ability to listen to the interview sessions, and this will be made known to participants as part of the informed consent.

6. Confidentiality of Respondents:

We will provide all respondents with informed consent language that ensures they understand the project purpose, that their participation is voluntary, and that their responses will be kept confidential. As part of the consent procedure, respondents will be asked to allow audio recording of the interview. Recording will not begin before participants have had the opportunity to ask for any clarification and provide consent. Participants will be asked to again confirm their consent when recording begins.

No participant’s identifiable information such as name will be included in the interview notes. All interview materials will be stored on a secure network drive, which will only be accessible to individuals granted access to work on the project. Interview notes will be zipped electronically and password-protected for email or secure file transfer delivery. Prior to forwarding any data to FDA, Westat will destroy all names and contact information of participants to protect their personal identity. Additionally, the interview notes and interpretive report delivered to FDA after message testing will omit all information that could be used to identify respondents.

All electronic data storage media that contain confidential, private, or proprietary information will be maintained within secure areas. Data collected in hard copy will be kept in locked cabinets when not in use.

7. Amount and justification for any proposed incentive

We will provide $50 incentives to participants at the end of each 45-minute interview in the form of virtual currency. The virtual currency are redeemable for a wide range of award items, vouchers, and publications. Research Now’s incentive scale is based on set time increments and panelist profiles and is applied equally across all study topics, sponsors, and data collection modes. These rates are also in line with those used by government agencies conducting cognitive testing studies documented in the QBANK5 at CDC.

8. Questions of a Sensitive Nature

We do not anticipate asking any sensitive questions in the interviews. Instead, the questions will focus on individuals’ knowledge and attitudes toward clinical trials, and their reactions to the messages and material.

Nevertheless, respondents will be told that they may skip any question that they do not want to answer or may stop participating at any time.

9. Description of Statistical Methods

We do not plan to use formal statistical methods in this study but rather qualitative analysis methods. Our analysis approach is based on the Framework method, as described in Spencer et al (2003). Framework is a matrix-based approach to data management, which facilitates both case and theme based analysis. The Framework method allows for data reduction through summarization and synthesis yet retains links to original data, in this case the interview notes. We will use the qualitative analysis software NVivo, which has included a Framework functionality since 2011. The software will allow us import interview notes, create links between the notes and the Framework matrices, and develop new queries or matrices as needed.

The Framework method will allow us to recognize patterns within the data. Findings will be supported with verbatim participant quotes and grounded in accepted principles of health communications.

References:

Spencer, L., Ritchie, J., & O’Connor, W. (2003). Analysis practices, principles and processes. In J. Ritchie & J. Lewis (Eds.), Qualitative research practice. London: Sage Publications.

BURDEN HOUR COMPUTATION (Number of responses (X) estimated response or participation time in minutes (/60) = annual burden hours):

Type/Category of Respondent	No. of Respondents	Participation Time (minutes)	Burden (hours)
Screener	250	3	12.5
Interviews	15	45	11.25
		Total	23.75

REQUESTED APPROVAL DATE: July 25, 2017

NAME OF PRA ANALYST & PROGRAM CONTACT:

JonnaLynn Capezzuto

Paperwork Reduction Act Staff

[email protected]

(301)796-3794

Brian Lappin

Office of Planning

[email protected]

(301)796-9126

FDA CENTER: Office of Planning (Office of the Commissioner)

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