Challenges & Opportunities in Creating Diversity in CLINICAL TRIAL RESEARCH
This month we continue to spotlight the inequity in health access by discussing ways life science companies can work to enhance relationships with minority patient stakeholders to achieve health equity and improve outreach strategies for clinical trial recruitment. With minority Americans expected to comprise more than 40% of the U.S. population by 2035 and 47% by 2050, addressing their health needs has become an increasingly visible public policy goal. Equitable research initiatives have fallen short, while most of life science companies remaining on the fringe of the issues that commit to programs advancing health equity. However, dealing justly with continuing racial “disparities” in clinical research and health care requires a conceptual paradigm that realistically assesses U.S. society’s contemporaneous and historical issues of diversity in patient research trials.
A multi-tiered plan that includes tactical steps to develop relationships with diverse patient stakeholders is key.
Life science’s endeavors to diversify clinical trials has fallen into a number of problems. The first is a perception problem which based on a Gallup poll of 58% (1) respondents stating their overall view of the pharmaceutical industry was negative. Despite advanced treatments of a broad spectrum of diseases in the last 25 years, and more than 300 COVID-19 treatments being researched or are in clinical trials around the world. The perception of life science companies puts a spotlight on the true value of the industry in light of the pandemic that has made every person in the world learn what it feels like to be at risk and with an unmet medical need. But it also lays bare the disparities of health equity amongst racial minorities and at risk communities. To improve minority patient health access in research, life science companies, legislators, and patient advocates should work to remove the inequity in clinical research that are built into the system of racial bias.
The historical strides to overcome the challenges to diversify clinical trials has been ongoing since the late 1990s, with the number of countries contributing to the clinical-trial data used by the US Food and Drug Administration (FDA) (>60%) to approve treatments (2). With initiatives highlighted through the National Institutes of Health (NIH) Revitalization Act of 1993. The mandate for inclusion of women and minorities (3) however has failed to improve minority accrual within life science. With minority enrollment in the pharmaceutical trials under 15 – 25% and the National Cancer Institute (NCI; part of NIH) trials for over 20 years meeting only 2% of approximately 10,000 NCI trials with sufficient minority participants to meet the goals outlined by the act (4).
The legacy of inequity in research has been difficult to uproot with the global expansion of clinical trials doing little to expand racial diversity with over 82 – 86% of clinical trial participants in 2014 to present date coming from participants of white ethnicity. In 2020 even large COVID-19 trials in the US continue to under-recruit African American and other minority participants, as observed in the approval of remdesivir as the standard of care for Covid-19. With remdesivir actively distributing supplies throughout the United States, data supporting the drug’s efficacy and safety in minority groups are limited. As shown in one of the largest ongoing COVID-19 global trials which are being conducted throughout US, with less than 20% of African American participants (5) in the placebo-controlled Adaptive Covid-19 Treatment Trial (ACTT-1) funded by the National Institute of Allergy and Infectious Diseases (NIAID). In addition contemporary oncology trials in the US continue to be characterized by an overrepresentation of white and male participants (80% and 59.8%, respectively) (6). It is worth noting that in addition to the limited participation by African Americans, the persistent lack of diversity hinders the likelihood that treatment effectiveness of an approved drug, and its side effects as well as the nature of those effects can all be represented in a patient pool that does not vary in ancestry.
Data were obtained from the COVID Tracking Project at The Atlantic (https://covidtracking.com/race. opens in new tab) for U.S.-based study sites in the Adaptive Covid-19 Treatment Trial (ACTT-1) and the GS-U.S.-540-5773 trial. Race and ethnicity data are not reported consistently by all states or in their entirety, since some states do not provide race and ethnicity data for Covid-19 cases (NY and LA), some use nonstandard categories, and others fail to provide data altogether (NE, not included here). Data were current as of June 10, 2020.
In recent years the validity of diversifying clinical trials has been challenged by barriers that include mistrust in the science community due to historical bias and unethical behavior, lack of outreach and recruitment of African American lead and site investigators, patient fear of randomization/clinical trial process, lack of health education on the benefits and patient rights, as well as other logistical issues (language, transportation and financial barriers).
In addition the goal to affect the attitudes and increase the intention of patients to enroll in a therapeutic trial needs to be coupled with a sensitivity to cultural differences by the life science community and their partners. Cultural competency’s potential to reduce racial and ethnic health disparities lays the foundation for a model that inform assessments of its validity. Life science executives can also take into account that this conceptual model could show how these techniques could theoretically improve the ability of clinical trial sites, and investigators to deliver appropriate clinical trial opportunities to diverse populations, thereby improving outcomes and reducing disparities when recruiting minority participants.
AI in clinical research
How AI can
AID In Patient Retention
Artificial intelligence (AI) is expected to affect all of our working lives. Computers that are able to simulate intelligent behavior can help address recruitment roadblocks created by logistics. By applying patient self-reporting, and AI diagnostic tools along with the use of mobile and telemedicine doctors visits. Retention of minority patients could be aided by AI and can help reduce the pervasive barriers in health education, and access to health providers.
It’s important to also implement a multi-tiered trial plan that continually emerges in developing relationships between pharmaceutical companies and minority-specialty medicine experts serving as lead investigators and study site physicians. These partnership’s can help to develop strategies to enhance insight and theories on the cultural affect on health care beliefs, choices, and treatment. As well as to provide recruitment planning tactics that rigorously works within a multi-site network of clinical trials in various disease areas. This strategy can have main facilitator patterns for recruitment that include: peer/family support, program incentives, commitment, and the desire to invest in key investigational site coordinating centers. Addressing these strategies creates a recruitment cycle that establishes tactical and agile methods that heighten and maintain its integrity. The goal is to build transparency and outreach to dispel feelings of mistrust by potential participants and reduce the likelihood of withdrawal or refusal to participate due to feelings that they are “test subjects” .
Working with non-profit organizations and diversity based media organizations that coalesce around African American and minority communities is an important component of outreach to patients. It can be especially helpful to highlight trial research and patient health education opportunities. Although not all interventions have an impact on participant target accruals into trials within the study time period. Overtime these strategies can work to change the behavior of the patient and patient caregiver. As well as the life science industry to contribute to improved outcomes of minority patients that enables a framework of clinical trial education, trust, compliance while bringing awareness to methods that can positively impact the improved global economics through health equity for all.
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