Use these resources to develop your clinical trials diversity plan.
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Differences that contribute to our individual identities, or association in a specific community/group. These are typically associated with visible physical traits but are not exclusive to these. These differences include age, race, sex, gender, socioeconomic status, educational attainment, sexual orientation, ethnicity, physical and mental abilities, religion or language.
Diversity is intersectional, no single vector fully represents anyone; each person’s identity is a composite of several diversity vectors.
Health and wellness are influenced by biology, environment, and lifestyle. Every individual’s experience with healthcare is based on biology and lived experiences, as represented by the diversity vectors. Therefore, diversity must be factored into clinical trials in order to advance healthcare. Diverse representation in clinical trials is essential to gaining sufficient information to better determine the efficacy, safety, and effectiveness of clinical treatments, for the development of new treatments, for wider use and applicability of treatments, and for advancing public health.
Recognizing that imbalances exist for different populations, across the different diversity vectors, and developing policies and practices to promote justice, impartiality, and fairness.
Not everyone is starting from the same place; deliberate efforts are needed to understand the needs of different groups and provide the appropriate resources to meet those needs. Equity in clinical trials will allow for increased representation for those conditions that are known to affect people at different rates due to diversity, and overall increased access to all clinical trials to fill the current gaps in knowledge.
Equity plays a role in clinical trials because of health disparities and the disproportionate disease incidences across diverse groups. Some groups are affected by greater rates of incidence which can result in higher mortality rates, for example black women have a three-fold higher incidence rate of triple negative breast cancer and die at higher rates than white women. At the same time, black women have less access to early diagnosis or participation in clinical trials.
The outcome of recognizing diversity and equity is ensuring that all are welcomed, valued, and have complete access to all resources and opportunities to fully participate in every step of the clinical trial lifecycle.
This includes financial compensation, additional educational materials, and cultural appropriateness. Inclusion accounts for other parameters in addition to those listed under diversity; additional factors contribute to underrepresentation in clinical trials such as geographic location, or diagnoses (or health condition).