About Diversity In Clinical Trial Summit
Diversity in Clinical Trial summit will include several conversations to address past issues in clinical trials, and new ethical rules/guidelines to safeguard patients’ safety and treatment during trials. We plan to educate minority healthcare providers on the importance of participation as well as speak on the impact of clinical trials on the health/wellness of our community as a whole. In addition, we will address lingering issues to combat fears/trepidations precluding clinical trial participation from all attendees.
Here are some facts about diversity in clinical trials:
Clinical trials have historically had a lack of diversity: Clinical trials have typically been conducted on a small and homogenous population, usually consisting of white males. This has been a longstanding issue in medical research.
Diversity is important for ensuring safety and effectiveness: Ensuring diversity in clinical trials is important for understanding how different populations may respond to treatment. If a drug is only tested on a specific group, it may not be safe or effective for other populations.
FDA requires diversity in clinical trials: The US Food and Drug Administration (FDA) has guidelines in place that require clinical trial participants to be representative of the population likely to use the drug or treatment.
Racial and ethnic minorities are underrepresented: Racial and ethnic minorities are often underrepresented in clinical trials. According to a 2018 FDA analysis, African Americans and Hispanics/Latinos are underrepresented in trials for various diseases, including cancer, cardiovascular disease, and HIV.
Gender diversity is improving: While racial and ethnic diversity is lacking, there has been an improvement in gender diversity in clinical trials. According to a 2019 analysis by the FDA, women represented 52% of participants in clinical trials for drugs and biologics that were approved in 2018.
Lack of diversity can lead to health disparities: The lack of diversity in clinical trials can lead to health disparities, where certain populations may not have access to the same treatments or receive the same level of care as others.
Efforts are being made to improve diversity: There are ongoing efforts to improve diversity in clinical trials. For example, the FDA's Office of Minority Health and Health Equity has developed initiatives to improve inclusion and diversity in clinical trials. Additionally, there are advocacy groups and community organizations working to increase awareness and access to clinical trials for underrepresented populations.
Having diversity in clinical trials is important for several reasons:
Scientific validity
Clinical trials that include participants from diverse populations can help to ensure that the results are generalizable and applicable to a wide range of people. This can help to reduce bias and increase the reliability of the findings.
Medical relevance
Clinical trials that include participants from diverse populations can help to identify potential differences in how drugs or treatments may work or be tolerated in different groups of people. This can help to improve the safety and efficacy of treatments for all patients.
Ethical considerations:
Clinical trials that include participants from diverse populations can help to ensure that treatments are being developed and tested in a way that is fair and equitable to all groups. This can help to address historical and ongoing disparities in healthcare.
Representation
Clinical trials that include participants from diverse populations can help to ensure that the populations are represented in the research and benefit from the research.
Recruitment
Including diverse populations in clinical trials can also help increase the recruitment and retention of participants, making it easier to conduct high-quality research.