PACT: Category and Tag Definitions

These Categories and Tags were developed by AACP staff members, with the assistance of Texas A&M University researchers, and assigned to activities being conducted by schools and colleges of pharmacy to increase diversity of clinical trials.

Categories*

Education: A formal process targeting any group that involves the distribution or acquisition of knowledge, skills, values, beliefs and/or habits regarding any aspects of clinical trials or community engagement to increase clinical trial diversity. The tag(s) should include who provides the education and the target audience(s) of the education.

Research: A formal investigation into any aspect of clinical trial diversity or any clinical research that includes enhanced efforts to recruit diverse participants that has an established purpose(s) and/or research question(s), including generation of statistics, utilization of medication(s), perception(s), treatment effectiveness, new treatment(s), etc. 

Service: An activity that is initiated or maintained to address clinical trial diversity (including public outreach and awareness efforts) that is not formal training and includes efforts that are designed to address social determinants of health and improve access to care outside of the clinical trial research. 

*Categories are not mutually exclusive. Activities may be included in more than one category.

Tags

Collaborators and Partners

Internal Institutional Partners – activities involving faculty, students, or staff from multiple schools/colleges (e.g., pharmacy schools, medical schools, schools of public health) within one educational institution.
External Partners – activities involving faculty, students, or staff from an education institution and an outside entity (e.g., local business, faith-based organizations, health departments). Includes for-profit and non-profit organizations.

Disease States/Conditions

Cancer – activities focused on cancer screening, diagnosis, or treatment.
Chronic Disease – activities focused on any chronic disease state (e.g., hypertension, diabetes)
Infectious Disease – activities focused on illness(es) caused by bacteria, viruses, or fungi (e.g., COVID-19, influenza).
Rare Disease – activities focused on a disease or condition that affects less than 200,000 people in the United States (as defined by the Orphan Drug Act).
Substance Use Disorder – activities focused on any substance use disorder (e.g., opioid use disorder).
Pregnancy/Lactation
Behavioral Health

Engagement/Communication Strategies

Inclusive Study Design – Activities where research study design considers diverse and inclusive recruitmentand engagement strategies. (Support for inclusion – activities where health professionals, community members, or others involved in clinical trial recruitment are offered preparation or training on the use of engagement and communication strategies to increase clinical trial diversity.)
Appropriate language and translation services – activities where appropriate languages are utilized, and translation services are offered when needed. 
Culturally appropriate materials – activities where materials are created to reflect or incorporate the intended audience’s identities, cultures, mindsets, beliefs, and/or personal experiences. 
Community-Based Research – driven by an equitable partnership involving shared decision-making and ownership among community members, community-based organizations, and researchers throughout the research process.

Barriers to Increasing Diversity in Clinical Trials Addressed

Language - Language is defined as “the principal method of human communication, consisting of words used in a structure and conventional way and conveyed by speech, writing, or gesture.
Mistrust - distrust is the idea that the patient actively questions and doubts the motives, sincerity, genuineness, and trustworthiness of the specific provider, researcher, organization, or institution. 
Access (physical/geographical) - defined as the geographic proximity of providers and facilities in relation to an individual and reflects the capacity of medical service markets to adequately meet the needs of the local population.15,16
Access (time)
Knowledge - Knowledge is a familiarity, awareness or understanding of someone or something, such as facts, information, descriptions, or skills, which is acquired through experience or education by perceiving, discovering, or learning. 
Literacy - Literacy has multiple components, including oral literacy (listening and speaking skills), print literacy (writing and reading skills), numeracy (the ability to understand and work with numbers), and cultural and conceptual knowledge.
Health Literacy - Health literacy is the degree to which individuals can find, understand, and use information and services to inform health-related decisions and actions for themselves and others.
Funding – underrepresented researchers receiving clinical trial funding, etc. 

Funding source 

Primarily External Funding
For-profit Funding – activities that received funding, including materials and gifts-in-kind, from for-profit entities such as pharmaceutical companies and retail pharmacies; activities in which pharmacy faculty or students partnered with a for-profit entity to create a product were excluded from this tag.
Government Funding – activities that received funding from Federal, State or local (city, county or municipal) sources.
​​Clinical and Translational Science Awards – activities that received funding from any clinical and translational science awards program (i.e., CTSA/CTSI/CTSC) through the National Institutes of Health (NIH).
Non-profit Funding – activities that received funding, including materials and gifts-in-kind, from non-profit entities such as community coalitions, foundations; includes local and municipal entities such as school boards and sanitation departments. 

Includes Internal Funding

Internal Funding – activities paid for by funds from the college or school of pharmacy or its parent institution; includes activities paid for by community donations.

Target Audiences

Racial/Ethnic Population – Unspecified

Racial/Ethnic Population – Specified
American Indian or Alaska Native – activities focused on people having origins in any of the original peoples of North and South America (including Central America), and who maintains tribal affiliation or community attachment.
Asian – activities focused on people having origins in any of the original peoples of the Far East, Southeast Asia, or the Indian subcontinent, including, for example, Cambodia, China, India, Japan, Korea, Malaysia, Pakistan, the Philippine Islands, Thailand, and Vietnam. 
Black or African American – activities focused on people having origins in any of the black racial groups of Africa.
Native Hawaiian or Other Pacific Islander – activities focused on people having origins in any of the original peoples of Hawaii, Guam, Samoa, or other Pacific Islands.
White – activities focused on people having origins in any of the original peoples of Europe, the Middle East, or North Africa. 
Hispanic or Latino – activities focused on people of Cuban, Mexican, Puerto Rican, South or Central America, or other Spanish culture or origin, regardless of race.  \

LGBTQIA+ - activities focused on individuals identifying as lesbian, gay, bisexual, transgender, queer/questioning, intersex, asexual, or “plus” to signify all of the gender identities and sexual orientation not yet fully described by words or letters (adapted from the definition from The Lesbian, Gay, Bisexual & Transgender Community Center).

Health Professionals

Pharmacists – activities are focused on researching or engaging with pharmacists in any setting. 
Student Pharmacists – activities focused on researching or engaging with student pharmacists, defined as any individual actively enrolled in a PharmD program.

Other Health Professionals 

Investigators – activities are focused on individuals involved in planning, executing, or analyzing research
Patients – activities are focused on researching patients or engaging with patients, where patients are defined as a person receiving or registered to receive medical care. 
Community Members – activities are focused on individuals in the community who are not considered patients, health professionals, or investigators
​
Special Populations

​Pregnant/Lactating Women – activities are focused on individuals who are currently pregnant or lactating
​Pediatric – activities are focused on individuals younger than 18 years old
Adults – activities are focused on individuals 18 - 64
​Older Adults – activities are focused on individuals 65 years of age or older 
Medicaid Population - low-income individuals, children, pregnant women, adults, individuals with disabilities and people aged 65 and older. Activities aimed to serve individuals eligible or receiving Medicaid benefits at the state these activities are taking place.
Medicare Population – older adults aged 65 and older, individuals with disabilities, and those with end stage renal disease.

Social Vulnerability Index

Indvidual's below federal poverty line – activities focused on individuals or groups meeting the poverty guidelines set by the Census Bureau at the time of the activity.

Health Professional Shortage Area – activities focused on geographic areas, populations, or facilities that have a shortage of primary, dental, or mental health care providers (as defined by HRSA). 

Rural – activities focused on individuals or groups living in a rural area as defined by HRSA (all non-metro counties; all metro census tracts with Rural-Urban Commuting Area (RUCA) codes 4-10 and large area metro census tracts of at least 400 sq. miles in area with population density of 35 or less per sq. mile with RUCA codes 2-3; all outlying metro counties without an Urbanized Area (UA) to be rural). 

Urban- activities focused on individuals living in urbanized areas with a population of 50,000 or more. Or individuals living in Urban clusters with at least 5,000 but fewer than 50,000.