Under representation of the Black community in clinical trials is a dangerous problem. Whether seeking to overcome ongoing hesitation of the Covid-19 vaccine or searching for moonshot cancer solutions, whatever the healthcare need demands, seeking results for diverse populations must be a priority. We can work together to restore trust in clinical trials to provide critical, inclusive, life-saving healthcare solutions for Black populations through three vital elements required to solve this dangerous problem: improving education, access to clinical trials, and driving clinical trial workforce diversity.
Imagine your loved one taking an approved medication for a serious, life-threatening condition, yet you are unsure if it is going to work, or worse, you are unsure if it will make their condition decline, because it was not tested in enough people like you. This is the reality for many in the black community today. Black representation in the clinical trials supporting the 371 drugs and biologics approved between 2007 and 2017 was 65% below census levels and disease population, according to Tufts Center for the Study of Drug Development.
Behavioral Health, Interoperability and eConsent: Meeting the Demands of CMS Final Rule Compliance
In a webinar on April 16 at 1pm ET, Aneesh Chopra will moderate a discussion with executives from DocuSign, Velatura, and behavioral health providers on eConsent, health information exchange and compliance with the CMS Final Rule on interoperability.
A recent advertising campaign seeking to educate diverse populations on the importance of participating in clinical studies said it best: “Diseases don’t discriminate.” This campaign points out the critical factor that creating trial diversity leads to discovering effective treatments for all populations. In one oncology example, The Black Breast Cancer Alliance, Touch, recently shared that the physiology of Black women has not been a consideration in clinical trial research. To begin to address mortality statistics, we must bring Black women into breast cancer research, as Black women under 35 get breast cancer at two times the rate of White women and die at three times the rate, according to the American Cancer Society. The ongoing work of Touch showcases that the lack of trial participation breeds from an absence of education, opportunity, and a lack of trust, thus needlessly putting the lives of Black women at greater risk.
The pandemic shone a light on our health disparities in the U.S., and I personally experienced hearing from many in the Black community who were going through the tough ethical dilemma of vaccine hesitancy. The prevailing themes in my conversations, whether relevantly concerned with historical mistrust due to the Tuskegee Syphilis Study or wrestling with the cancer treatment advancements due to the cells of Henrietta Lacks and it being done without her consent, led me to focus on the importance of awareness and education of clinical trial participation and the impact for the Black community. Many companies including mine are focusing on driving the pursuit of diversity in the clinical trial workforce and seeking to build trust in order to encourage more diverse patient participation in clinical trials.
According to the Tufts CSDD study, access to trials, including transportation issues, and lack of minority clinical investigators were reasons for lack of participation in the non-White communities. This is why we must have solutions that allow participants to engage from a place of comfort and trust ― their own home ― to allow clinical trial sponsors and contract research organizations (CROs) to take the trial into the community through technology, including into underserved populations. This helps in building a bridge to gain essential evidence for inclusive healthcare solutions.
We are already seeing evidence that the option of remote participation matters. In a recent JAMA study, Dr. Jenell Stewart also highlighted the need for novel strategies for equitable access and recruitment of diverse clinical trial populations. Stewart found that creating opportunity for remote trial participation is a difference maker, stating that “remote trial participation and online recruitment may be associated with improved research equity and inclusion of participants from more diverse racial, ethnic, and geographic communities.”
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
We also have findings that the staffing of trials makes an impact on engagement. Ken Getz and his research team also presented in the Tufts study that sites with high staff diversity are more likely to be in urban settings with larger populations of low-income patients and fewer staff. They noted as well that the patients at these sites are more likely to perceive value in staff diversity. Thus, increasing participation. If there is someone who looks like me and asks me to participate in a study, I’d be more likely to engage, which could lead to more diverse clinical trial evidence and ultimately providing life-saving medication for more patients.
Several industry organizations are playing their part to solve the lack of patient diversity in clinical trials. The Association of Clinical Research Organizations (ACRO) and its members, for example, are actively working and committed to increasing diversity, equity, and inclusion in clinical trials. By focusing on four principles and associated actions, the CROs and technology providers of ACRO are working toward a clinical research ecosystem that is representative of the world we live in. These principles include: improving health equity through access to trials; empowering research partners (patients, sites, HCPs); partnering with stakeholders and policymakers; and driving workforce diversity, equity and inclusion through workforce program support and fostering relationships with minority healthcare associations.
While fighting a global pandemic, we learned a great deal about our ongoing health inequities and how, when we work together to overcome existing barriers, we are able to quickly provide life-saving solutions for all populations. We can do that again for this dangerous problem of under representation of the Black population in clinical trials. In our scientific community, let’s all intentionally focus on offering education, building awareness and bringing the trials themselves into the Black communities, and do so with a trusted representation in the trial workforce, restoring trust and saving lives.
Photo: RyanJLane, Getty Images
Clario has a long history of ensuring diversity, inclusion and sustainability, something the organization is committed to improving under the leadership of Otis, who is Chief Diversity, Inclusion and Sustainability officer. He also works with employees, customers and shareholders to ensure they fulfil their environmental, governance and social responsibilities.
With over 20 years’ experience of working in pharmaceuticals, Otis is passionate about the industry and holds expertise across clinical informatics, business analytics, sales, project management and research and development. He has held positions at a number of global companies including Merck, ICON and Syneos Health.
