There are practical and operational barriers that prevent routine participation of underrepresented, underserved, and diverse populations in clinical research. These must be addressed to promote change. While many challenges exist, for each section, we provide a key summary and recommendations to address appropriate representation in clinical research.
These section are interdependent and dynamic. We have much to learn to implement and sustain change.
Promoting diverse representation and inclusion in clinical research is a shared responsibility by all stakeholders in the research enterprise.
Clinical interventions and research aim to improve disease diagnosis, treatment, and/or prevention to promote health. Active engagement of patients and participants, their families and caregivers, advocacy groups, the community, and health care providers is necessary for successful implementation of clinical research.
A diverse workforce is also necessary to support, promote, and exemplify diversity.
Study Design, Conduct, and Implementation
Issues related to study design, conduct, and implementation should be considered through the lens of including diverse populations. These topics include but are not limited to:
- Product lifecycle
- Research question
- Study design
- Eligibility (inclusion/exclusion) criteria
- Recruitment plans
- Feasibility assessments
- Retention issues
- Logistics of study conduct
- Participant payments
Data Standards and Analysis
How data are collected, reported, and analyzed are specific to the disease or condition and to the research study. The collection, reporting and analysis of the data, relevant for diverse populations, should be planned.
Data variables, collection, and reporting. Primary data should be collected with the greatest specificity possible so that it can be categorized, shared, and/or analyzed in different ways for different purposes. Once the specific data are known, then any risks of that collection, specific to the subgroup and population, can be identified, mitigated, and explained to potential participants.
Data analysis. Analysis should include subgroup identification and analysis.
Stakeholder Commitments and the Future
Stakeholders involved in the clinical research enterprise include funders, sponsors, CROs, research institutions and sites, investigators and their study teams, patient and patient advocacy groups, and others. Stakeholders are also institutional review boards/research ethics committees, human research protection programs, journal editors, and others.
No single entity can achieve or is responsible for diversity alone. Everyone shares responsibility for inclusion of diverse populations in clinical research.
Stakeholders rely on, and must be comfortable with holding, another entity accountable and help one another to achieve success.
Shared accountability may be formalized by contract or informally through conversation and common alignment.
We offer the following set of initial questions for an organization to consider:
The following questions highlight the internal structure, messaging, and coordination across and throughout the organization to promote diversity in research
- Has the organization posted a public statement of commitment to diversity and inclusion in clinical research?
- Does the organizational mission or corporate responsibility statement reference diversity and inclusion?
- Does the strategic plan include programmatic goals related to diversity and inclusion?
- Are those responsible for fulfilling expectations and/or driving implementation appropriately identified and positioned within the organization?
- Are the operational requirements for achieving diversity coordinated across the necessary organizational components?
- Does messaging and communication within the organization follow health literate language principles and promote diversity and inclusion?
- Are there organization-wide efforts to recruit and train a workforce that can effectively develop and implement a diversity agenda?
- Has the organization allocated resources necessary to fulfill these functions?
- Does the organization have metrics to measure expectations and plans?