Diversity in Clinical Trials - Background
The Federal Drug Administration (FDA) issued non-compulsory guidance on clinical trial diversity to encourage diverse populations in clinical trials and improve the applicability of clinical trial results. The guidance recommends diverse clinical trial populations to better understand the safety and effectiveness of medical products across race, ethnicity, and gender.
In particular, the guidance recommends that sponsors consider including women, racial and ethnic minorities, and older individuals in clinical trials, as clinical research in pharmacy historically underrepresented these groups. It is also recommended that individuals with disabilities and those from diverse geographic regions be included.
In investigational new drug and biologics license applications, the FDA recommends that sponsors provide justification for the inclusion or exclusion of specific populations in the anticipated clinical trials. Outreach and recruitment strategies are encouraged as a means of ensuring diverse populations are represented in clinical trials.
It is important to note that the FDA guidance on clinical trial diversity is not a requirement but, instead, a consideration for designing and conducting clinical trials in pharmacy.
Ensuring clinical trial diversity
There are several important considerations for sponsors to ensure diversity in clinical trials. Here are a few key points:
- Importance of diversity: Ensuring clinical trial diversity is essential for several reasons. First, it helps to ensure that clinical trial results are generalizable to a diverse population. Secondly, identifying potential safety and effectiveness differences in diverse populations is valuable.
- Inclusion of underrepresented groups: Sponsors should consider including historically underrepresented groups in clinical trials; women, racial and ethnic minorities, and older individuals have traditionally been excluded.
- Outreach and recruitment strategies: Outreach and recruitment strategies that ensure the representation of diverse populations in clinical trials must be considered by sponsors. This may include partnering with community organizations, targeted advertising, and transportation and logistical support to encourage clinical trial participation.
- Justification for inclusion or exclusion: Investigational new drug and biologics license applications need to include justifications for the inclusion or exclusion of populations in a clinical trial.
Overall, sponsors must be proactive in considering diversity in clinical trials and must consider the potential impact of diversity on study results and generalizability. However, this is not enough.
The missing ingredient: trust
Trust is an essential factor when it comes to clinical trial diversity. Building trust with diverse populations can be challenging; however, there are several ways for sponsors to build trust with diverse populations. For example:
- Provide clear and accurate information, including the study purpose, potential risks and benefits, and study participant rights.
- Engage with the community and seek input from diverse populations to better understand their concerns and perspectives. This may involve partnering with community organizations or holding public meetings to gather feedback.
- Be transparent about research processes and clinical trial results. This includes being open and responsive to questions and concerns from study participants and the community.
- Build relationships with diverse populations and establish trust over time. Work with community leaders, participate in community events, and be responsive to community needs and concerns.
It is important for sponsors to take these necessary steps to build trust and to be transparent to ensure that clinical trials are inclusive and representative of the wider population.
Community Pharmacists – the bridge to the community
Sponsors traditionally think of doctors and nurses (general practitioners) when they consider community leaders or healthcare providers. However, this approach completely overlooks the most trusted community healthcare provider, the one that sees patients more often than any other provider and best knows the patient: the community pharmacist.
Involving community pharmacists in clinical trials provides numerous advantages:
- Access to patients: Community pharmacists have regular contact with patients. They can provide clinical trial information and identify potential study participants. This may be particularly helpful when recruiting diverse populations who may not otherwise be aware of clinical trials or don’t have access to healthcare providers who can provide clinical trial information.
- Knowledge of the community: Pharmacists are well-respected members of the community and understand the health needs and concerns of the community. This is valuable for developing outreach and recruitment strategies tailored to community needs.
- Facilitating communication: Community pharmacists can serve as a bridge between clinical trial sponsors and the community. They can facilitate communication about clinical trials and provide study information to patients and the community.
- Providing care: Community pharmacists provide care to study participants during clinical trials, including administering medications and providing follow-up care.
Involving community pharmacists in clinical trials is an effective way to reach diverse populations and provide care to study participants. Working closely with community pharmacists is valuable for sponsors and critical for clinical trial planning and execution.
Social Determinants of Health (SDOH) – painfully overlooked
Beyond the advantages of community pharmacists as trusted healthcare providers is their understanding of patient SDOHs. Through long-term relationships, community pharmacists know the social determinants of health (SDOH), overall health status, lifestyle, and social circumstances of their patients. SDOHs include the conditions in which people are born, grow, live, work, and age, all of which can have a significant impact on an individual’s health. Community pharmacists are in a unique position to understand patient SDOHs. This helps identify potential clinical trial participants and allows tailored outreach and recruitment strategies.
Community pharmacists often know patient SDOHs, including:
- Housing: Does the patient have safe and stable housing, which impacts overall health and well-being?
- Transportation: Is reliable transportation available for the patient? This affects an individual’s access to healthcare.
- Income: Financial resources often determine an individual’s ability to afford healthcare and medications. Does the patient have a steady income and health insurance or Medicaid/Medicare?
- Education: Higher levels of education are often associated with better health outcomes. Does the patient need more training to ensure a better understanding of procedures or medication and to encourage long-term compliance?
- Social support: Having a supportive network of family and friends is vital for overall health and well-being. Community pharmacists often know the extended families and community connections that make healthcare more viable for many patients.
Community pharmacists are in a unique position to help improve clinical trial diversity and outcomes. With regular patient contact, they can identify potential study participants and provide clinical trial information. This is particularly true within diverse populations that may not otherwise be aware of clinical trials or have access to healthcare providers who can provide clinical trial information.
Community pharmacists can also offer clinical trial education and information to patients and the community, facilitate communication between clinical trial sponsors and the community, and provide care to study participants during clinical trials. Involving community pharmacists in clinical trials is an effective way to reach diverse populations and provide care to study participants. It is a valuable means of improving both clinical trial diversity and outcomes.