AmeriTrial specializes in designing and conducting large-scale OTC ‘switch’ trials; OTC actual use studies; post approval OTC product comparison/marketing studies and OTC label comprehension studies.  OTC trials are conducted in actual retail sites located in large shopping centers.  This is in compliance with FDA guidance calling for OTC research to be conducted in non-medical ‘naturalistic’ sites.  In these 'naturalistic' retail sites, actual consumer behavior in self-selecting, de-selecting and using OTC products can be observed and documented.

AmeriTrial develops two types of 'naturalistic' retail sites in which OTC trials are conducted.  The two types are 1) Large chain and independent retail pharmacies, and 2) Actual retail storefronts.  Both pharmacy and storefront sites are located in large shopping centers disbursed regionally throughout the United States.  Sponsors make the final decision on which type retail site is used based on protocol-specific requirements.  See Pharmacy and Storefront links for a verbal and visual summary of how these retail sites are developed and operated based on trial-specific requirements.

Types of OTC Trials/Studies Conducted by AmeriTrial

Rx-to-OTC Switch Trials: Trials required by FDA to support application to switch a product from prescription to over-the-counter status. These trials test the participant's ability to appropriately self-select, de-select and self administer OTC type products.

The pivotal Rx-to-OTC switch trial is usually a two-arm parallel design that collects and compares the efficacy and safety of the test drug when acquired in a traditional medical Rx environment versus a retail OTC environment.

Actual Use Trial: In actual use trials, researchers observe actual product use patterns and evaluate the study participant's ability to self-select and de-select OTC products.

Said another way, in a use study, actual consumer behavior can be observed and tested as participants purchase and use OTC products in a real-life, retail environment.

Head-to-Head Comparison Studies: Compares efficacy, safety and consumer preferences in actual use of two or more OTC and/or potential OTC products.

Product Crossover Comparison Studies: Measures consumer preferences in using multi-products within the same therapeutic area.

Post Approval Marketing Studies: Develops marketing data in post approval stage of product marketing and distribution.

Label Comprehension:  Develops and tests levels of consumer comprehension of OTC product labels.

OTC Trial Services Offered

• Pre-planning
• Study Design
• Protocol Development
• OTC Site Development
• Regulatory Approval
• OTC Site Staffing*
• Investigator Meeting/Training
• OTC Site Staff Training
• Site Monitoring
• Trial Management/Data Management
• Report Writing
• Quality Assurance Auditing

(*Investigators are nurses, pharmacists or physicians.)

OTC Geographic Scope: Entire USA

• Storefront OTC Retail Sites:  Developed quickly in any geographic region of U.S.
• Pharmacy OTC Sites:  Located regionally or nationally in any demographic or geographic market in U.S.
• Regional and National Database:  Sites incorporate untapped geographic areas.
• Regional Patient Recruiting:  Emphasis on untapped geographic areas and naive patients.
• Rx-to-OTC Switch Trials:  Storefront retail sites paired with Rx medical sites in each geographic market.
• OTC Actual Use Studies:  Sites are actual storefronts and/or retail pharmacies.

Examples of Recent OTC Trials/Studies

Type of Study	Indication
Rx-to-OTC Switch	Cholesterol Lowering
Head-to-Head Product Comparison	Nicotine Replacement
Head-to-Head Product Comparison	Nicotine Replacement
Head-to-Head Product Comparison	Dermatology
Open Label Self-Selection	Dermatology
Open Label Self-Selection	Pain Management
Restricted Access Use Trial	Cholesterol Lowering
Restricted Access Use Trial	Cholesterol Lowering
Open Shelf Use Trial	Gastroenterology
Preference Cross Over (3 products)	Nicotine Replacement
Head-to-Head Product Comparison	Gastroenterology
Product Comparison	Allergy
Rx-to-OTC Switch	Nicotine Replacement