Diversity and Inclusion in Clinical Trials

Although the lack of diversity in clinical trial populations is not a new issue, it became a major concern in 2020 as the spotlight was placed on drug development in general due to the COVID pandemic.?The FDA's final guidance on Enhancing the Diversity of Clinical Trial Patients -- Eligibility Criteria and Enrollment Practices was issued in November 2020. This marked a significant milestone.?

To drive this change, we need to implement several initiatives, such as patient journey workshops for patients from minorities. In it, we can assess how easy the clinical trial recruitment materials were to comprehend and whether they were inclusive for diverse audiences.?Workshop participants were also asked which channels they prefer for information about clinical trials. Clinical Operations teams need to work closely with advocacy organizations (e.g. Alport's syndrome Foundation, National Hispanic Medical Association (NHMA) in order to host advisory boards that gather feedback from patients and doctors.?This feedback can help update of patient materials and expansion of digital recruitment channels.?The ultimate goal is to use the feedback to increase minority patient recruitment to clinical trials.?

Additionally, sponsoring and participating in global clinical development workshops that emphasized minority patients in clinical trials will aid in raising awareness.?These workshops should feature representatives from academia as well as experts in a particular disease area.?These events can address trust issues that often come up within the community and highlight the importance of culturally sensitive communication between the industry and the underrepresented.?

Implementing new standards in interactions with patients, and developing recruitment and site selection strategies to ensure that any clinical trial launches successfully is vital to bridging the gap between that is often common among minorities?These include communicating with patients in an easy-to-understand manner; choosing a wider range of qualified and well-distributed clinical trial sites; and engaging directly with the community or word-of-mouth, face-to-face interactions rather than using standard communication channels (e.g. social media, websites) that are available to clinical trial sites.?Biotech needs to become active in various organizations that promote inclusion and diversity. The Clinical Transformation Trials Initiative is one of these organizations. It is promoting the adoption of best practices to improve the efficiency and quality of clinical trials.?The Center for Information & Study on Clinical Research Participation is another example. This non-profit organization aims to increase awareness of clinical research among patients and the general public.

BIOPHARMA MUST QUESTION ITSELF

Despite the fact that most people say they are interested in participating in clinical trials, very few of them actually do.?In recent years, many biopharmaceutical companies have been paying close attention to patients' perspectives regarding participation in clinical trials.?It was important to find barriers, especially for women and minorities in the U.S.?A recent study by the Center for the Study of Drug Development, Tufts University School of Medicine found that minority patients, especially those of Black or African descent, are the least represented subgroup for clinical trials. Participation rates were 65 percent lower than their general census levels and for the disease population.?Research by Tufts also found that minority nurses and physicians have very low rates of referring patients to clinical trials.?To improve the diversification of clinical trial enrollments, the pharma industry must ask the following questions:

1.?How can we ensure an equitable approach for the inclusion of patients with diverse backgrounds?

2.?How can we encourage diversity and inclusion in the clinical trial environment through our investigators and clinical trial sites??

3.?What aspects of our research design could inadvertently make it difficult for patients with diverse backgrounds to participate in clinical trials?

We need to be open to our biases and weaknesses in order to improve the clinical trial infrastructure and optimize treatment for all patients.?It's not about changing the status quo in clinical trials regarding diversity. It's about being fair and doing the best for all patients.

KEY ACTIONS THAT SUPPORT CLINICAL TRIAL DIVERSITY

1. A protocol-focused assessment that focuses on diversity for patients
2. Site-recruitment strategies and early assessment of patients
3. Options for patient support strategies including decentralized clinical trials

WHY ARE PEOPLE WITH COLOR UNDERREPRESENTED DURING CLINICAL TRIALS?

Clinical trials are feared by many members of minorities.?This is not surprising.?There has been a history in the black community of medical experiment exploitation.?Although the industry requires trial participants to be informed of details about participation in trials, the history of exploitation has caused mistrust and reservations about clinical trials, despite the potential benefits for patients and the wider healthcare community.?There are many people of color without access to healthcare. This is not only a source of distrust.?They are not able to find out about clinical trials or how they can help them.?Although conversations about clinical trials are often held at the most advanced research facilities, these conversations do not occur very often between doctor and patient for people of color.?Patients are often unaware of the best ways to locate clinical trials and how to contact advocacy groups.?Many ethnic communities accept the advice of doctors as gospel and don't seek alternative options or advocate for their health.?If a doctor or another healthcare professional recommended clinical trials, it is unlikely that such individuals would be aware of them.

It is important to invest in long-term relationships and to work with the right advocates to build trust.?Trusted sources can help patients and alleviate fears about safety.?Patients of color should be able to access educational materials that explain the potential benefits of clinical research. They also need to know how to ensure they are ethically conducted and pay attention to safety.?Sharing testimonials from past participants can help to show that trial participation can be a positive experience. This can also make a big difference in the development and testing of new drugs.?It will be a motivator to participate by building trust with healthcare providers.?We must educate and raise awareness. However, it is important to reduce the disruption that clinical trials can cause to patients' daily lives and families.?Some minority patients may require assistance due to childcare, work schedules or transportation.?Many patients will find it easier to participate by providing a letter from the clinic to their employer.?Participation is easier due to the increased use of remote clinical trials, which are conducted remotely via telemedicine and mobile/local health providers.?

Finally, patients of color will benefit from the presence of medical professionals of color in the healthcare sector. This also enhances the doctor-patient relationship.?Therefore, sponsors should allocate resources to improve diversity among principal investigators.?COVID-19 has been a source of great pain and suffering for millions of Americans. However, it has also proven to be an opportunity for innovation and transformation.?There is no better time to address healthcare disparities in the United States, particularly when it comes to clinical trials.?Clinical trial sponsors must recruit minorities to take part in clinical trials. They should also speak to them about the safety and efficacy and how to make sure that treatments work for all.?