Perspectives of stakeholders on furthering research through representative clinical trials
Racial and cultural diversity among clinical trial participants is critical to advancing science-driven solutions aimed at better understanding the needs of persons afflicted by the disease or condition under investigation. How will the biopharma sector do this? Multistakeholder collaboration is the answer.
A brief overview
Diversity in clinical trials is essential for health equity.
Participants in racially and ethnically diverse clinical trials, who are representative of the targeted patient population most likely to use a drug once licenced, can assist influence the safety and efficacy evaluation of new medicines, as well as the usage of new medicines for patients. These findings may lead to a better knowledge of some diseases, which may lead to better prevention and treatment for all populations, including racially and ethnically diverse communities.Members of underrepresented populations who engage in clinical trials not only assist advance scientific discoveries, but they may also help improve public views and promote public trust in pharmaceuticals when people see and hear about clinical trial participants who look like them. Finally, increasing diverse clinical trial participation may assist enhance health equality by offering access to potentially lifesaving medications and high-quality health care that would not otherwise be available. Clinical trials are the most common way for people to acquire unapproved experimental medications. 1
The COVID-19 epidemic and racial unrest that erupted in 2020 in the aftermath of the sad deaths of George Floyd, Breonna Taylor, and so many others exposed long-standing health and socioeconomic disparities in the United States. The disproportionate impact of COVID-19 on Black and Latinx communities across the United States exemplifies these discrepancies in health care and health outcomes.
Significant, quantitative health inequalities have been reported across many dimensions, but they are notably visible along racial lines, with racially and ethnically diverse communities facing hurdles that can contribute to lower overall health than white people. Systemic racism in health care is frequently a major contributor. Racism has had a substantial impact on the way the health ecosystem is created in the United States, contributing to poor health outcomes for underrepresented people. 2 Increasing diverse clinical trial participation is one method to promote better health outcomes and enhance treatment for racially and ethnically diverse communities.
To address the issue, industry and ecosystem activities have grown.
Improving meaningful representation of diverse participants in clinical trials will aid in the provision of information regarding drug response and measures of safety and efficacy in historically underrepresented and understudied populations, particularly Black and Latinx communities. In response to the continued need to address health care inequalities, stakeholders from academia, government, patient advocacy, community leaders, health care providers, technology experts, and clinical research institutions from throughout the clinical trial ecosystem have come together.(CROs) have lately boosted their efforts in the areas of diversity, equality, and inclusion (DE&I) in clinical trials. These approaches include raising clinical trial awareness and improving clinical trial representation, understanding that no single stakeholder can effect long-term change. Here are several examples:
In the summer of 2019, the FDA provided draught guidance on increasing the diversity of clinical trial participants, which was later approved in November 2020.
In February 2018, the Multi-Regional Clinical Trials (MRCT) Center at Brigham and Women's Hospital and Harvard established an MRCT Center Diversity Workgroup, which produced a guiding document5 in 2020 and a toolkit6 in early 2021.
In November 2020, the Pharmaceutical Research and Manufacturers of America (PhRMA) and its member firms issued the first-ever industrywide principles on clinical trial diversity, titled "Principles on Conduct of Clinical Trials & Communication of Clinical Trial Results." These principles go into force in April 2021.
The American Medical Association collaborated with the All of Us initiative last year to "get deeper insights into the molecular, environmental, and behavioural factors on disease in order to improve prevention and treatment."
A paper titled "Strategies for assuring diversity, inclusion, and meaningful involvement in clinical trials" was also issued by the National Academies of Sciences, Engineering, and Medicine.
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