Rx-to-OTC Switch Expertise
Consultation
Labeling development
LABEL
Comprehension
Technology development
SELF SELECTION
Self-Selection
IQVIA Consumer Health has designed and conducted many customized self-selection and/or self-diagnosis studies. These studies are based on best practices in consumer research and on Regulatory Agency guidelines. The study design is based on the needs of the program.
Each program is customized to the sponsor’s goals and needs. Often the testing begins with pre-testing and proceeds to pilot testing and finally to quantitative testing. Self-selection testing can be accomplished in a variety of ways including combining the testing with either label comprehension or actual use studies or conducting a stand-alone self-selection study.
If you have proprietary name and umbrella brand needs, have specialized testing that we have developed, Discernment Testing, which will assist you identifying potential areas of consumer confusion so that the labeling for your new product can be clear to consumers of normal and low literacy.
IQVIA Consumer Health has developed labeling for a variety of products and conducted nearly 500 comprehension studies that have been submitted to regulatory authorities.
IQVIA Consumer Health can assist in developing your labeling. We have developed many types of labeling including:
• Drug Facts Labels (DFL)
• Instructions for Use (IFU)
• Consumer Leaflets
• Educational materials
• Medical Guides
Our first-pass design can save you time and money in your testing by starting with labeling that is in consumer-friendly language.
Our experienced consultants will work with you to create a regulatory strategy and a development program strategy for your product. This includes reviewing any Regulatory Agency communications and planning for upcoming meetings and Advisory Committees. The goals of the program will be met through iterative programs to evaluate label comprehension, self-selection and actual use studies. Some programs require additional clinical studies to be conducted; we can design and conduct your clinical trials too
Consultation
Proprietary Name/
Umbrella Brand Testing
Self-selection
Actual use
IQVIA Consumer Health has designed and conducted nearly 30 actual use studies of studies for pivotal Switches, including some of the most recent and complex Switches.
We have conducted nearly 200 consumer use studies for various needs including claims and Phase IV commitments. We evaluate the needs of the program and then customize the design for your actual use study. We have conducted a range of studies from small and targeted studies to large-scale actual use studies in special populations. Most studies range from 500 to 1500 subjects and include a home use period in which the consumer uses the product in an unsupervised OTC environment.
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Rx-to-OTC Switch Expertise
Regulatory strategy and program design
Labeling development
Drug facts labeling, consumer and instruction for use leaflets, educational materials or medication guides
IQVIA Consumer Health has also developed a novel and accelerated approach to initiate the testing. Ask about our ACE© (Accelerated and Compressed Evaluation) Testing.
Targeted label comprehension studies are sometimes required after data has been analyzed from pilot and quantitative testing and prior to NDA submission. IQVIA Consumer Health is very experienced in recruiting special populations for targeted testing. This may include pediatric, adolescent or geriatric populations, various literacy levels, or populations with special medical conditions.
Proprietary name and umbrella brand label testing
Self-diagnosis
A self-diagnosis confirmation can be added to the design if there is a concern about whether the consumer can correctly identify the condition for which the product is intended. This testing may involve examinations from medical professionals and/or diagnostic testing as a confirmation to the consumer’s decision-making.
Self-selection and self-diagnosis
If your program requires both self-selection and self-diagnosis testing and confirmations, IQVIA Consumer Health has a novel approach for combining the needs of both endpoints, an S3 Study which combines self-selection, self-diagnosis and a confirmation of both by a medical professional.
IQVIA Consumer Health will work with you to create the design that will best meet the needs of your program and supply the data needed for your defense to Regulatory Agency committees.
We utilize a variety of research sites from simulated retail environments to actual retail environments and in some cases clinical sites are utilized if clinical measurements are required. When actual retail environments are utilized, we use our drug/food/mass stores that reflect the settings in which most consumers purchase their OTC products.
Each program is customized to the sponsor’s goals and needs. Self-selection can be incorporated into the actual use study or studied in a separate study. IQVIA Consumer Health will work with you to create the design that will best meet the needs of your program and supply the data needed for your defense
ACTUAL
USE
Technology Development
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Utilizing technology to support safe use of a product if labelling is not sufficient is a growing opportunity for consumer health companies. IQVIA Consumer Health has the experience and expertise to help you identify and validate the right technology to provide decision-support algorithms, education and guidance that can support your switch application.
Proprietary name and umbrella brand label testing
Actual use
Proprietary name/Umbrella brand testing
Label Comprehension
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Label Comprehension studies are conducted in iterative stages to evaluate and optimize the language related to the product uses, warnings, precautions and directions.
IQVIA Consumer Health has designed and conducted hundreds of label comprehension studies, based on best practices in consumer research and on the FDA’s “Guidance for Industry: Label Comprehension Studies for Nonprescription Drug Products” (August 2010). Studies are often conducted in an iterative fashion by testing various label versions in rounds of testing.
Proprietary name and umbrella brand label testing
Proprietary name/Umbrella brand testing