Introduction

 

Why do we do clinical trials? 

 

Clinical trials are important to gather enough data/evidence that a new therapy or product works and is safe. But,  patients may not respond equally to medical products.

 

For example, women may react differently than men. Blacks or Hispanics may also respond differently than Caucasians. Some therapies like Thiazides and Calcium channel blockers are more effective in blacks than other races.

 

For this reason, diversity and inclusion in clinical trials are needed. This ensures that study participants represent patients who need the product in the real world. This further reduces bias in clinical trials and increases equity in the healthcare sector.

 

However, this is not mostly the case because racial and ethnic minorities and other diverse groups, including sexual and gender minorities or socioeconomically disadvantaged populations, are underrepresented in clinical research.

 

 

 

 Lack of diversity in clinical trials

 

Race and ethnic minorities have been underrepresented in the past and that is still the case today.

 

The Food and Drug Administration (FDA) reviewed products released between 2008 and 2013 and found that  20% of the time, people from different racial or ethnic groups reacted differently to the products.

 

For example, although Blacks account for at least 21% of deaths from Covid-19, they made up only 3% of clinical trial participants for the covid-19 vaccine; Similarly, other minority populations were also underrepresented.

 

Therefore, while general scientific knowledge and medical treatment have grown rapidly in recent years, African Americans, Latinos, Africans, and other ethnic groups have benefited less from these advances than their Caucasian counterparts.

 

The elderly population is also usually excluded from clinical trials, even though they represent the largest proportion of people with comorbidities who still need the product.

 

It is a major challenge for biotechnology or pharmaceutical companies to develop new medical products or devices for diverse patient populations with the inclusion of minorities.

 

Here's why:

 

1. Oversight: Biotechnology and pharmaceutical companies typically design their clinical trials around what will get their drugs approved and marketed quickly. They prefer to use the same participants and locations because it is easier.

 

2. Increased cost:  If the inclusion criteria are further extended to other populations, there is a risk of more adverse events and therefore it may take longer to get FDA approval. In the end, it would cost more to bring the product to the market which would lead to more expensive products.

 

3. Poor access: Even when a disease is more prevalent in certain minority populations, it is still difficult for researchers to reach the right people. For example, some tropical conditions like Onchocerciasis, which are very common in Africa, may not be well studied because it is difficult for most researchers to reach the affected populations.

 

 

Diversity in clinical research is also difficult to achieve because participants, especially in minority groups, do not want to volunteer.

 

This is due to:

 

1. Misinformation:  There may be low awareness of the clinical trial process and fear of stigma if they participate. This is due to negative beliefs and norms. They may also feel uncomfortable with the investigators or staff.

 

2. Language barrier: Different participants may speak different languages ​​and may not understand the research aims and protocol.

 

3. Time and financial constraints:  Due to long distances and increased transportation costs, it may be difficult to reach the clinical trial sites. Add to this the time lost during the clinical trials, which can result in the loss of wages that should have been earned during that time

 

 Importance of diversity in clinical trials

 

The FDA encourages the participation of diverse populations in clinical trials. 

 

In disease research, results may not be generalizable when study participants are of the same sex, age, or ethnicity.

 

But the diversity in clinical trials leads to :

 

1. Comprehensive data enhances understanding of racial and ethnic differences in treatment response, which in turn can help reduce outcome inequalities.

 

2. Some minority patients may benefit from early access to therapy, potentially prolonging or saving their lives.

 

3. Closing knowledge gaps can improve the quality of healthcare decision-making, the ability to advise people on how to reduce risk, optimal treatment responses, and even the development of more effective drugs or interventions.

 

4. Involving diverse population groups in the planning and execution of trials such as Covid-19 vaccines can also help build public confidence in the safety and effectiveness of the vaccines for everyone.

 

5. In a population as large and diverse as Africa, research on African diseases will give them better access to healthy options and more treatment options for their population. The same principle applies to all races and ethnicities.

 

Physicians and researchers should focus on inclusive practices to ensure participants from all economic and experiential backgrounds are represented.

 

How do you ensure diversity in clinical trials

 

Here are 8 key ways to improve diversity in clinical trials:

 

• Building trust with the community: Researchers and community members can work together to design and conduct studies. Meaningful discussions with community members can increase their understanding of the need to volunteer for clinical trials and build lasting relationships. Rural medical centers can also be used as research sites.

 

• Patient Advocacy Groups: It is important to reach out to patient advocacy groups, especially when it comes to rare diseases. This ensures access to the right participants while educating them about the product and being involved in their awareness campaigns.

 

• Outreach to communities: This will help the patients feel valued. These activities may take place in public places such as town squares, churches, and local community centers.

 

• Diversity of researchers or clinicians conducting clinical trials: Diversity of investigators and other clinical trial staff reduces bias in clinical trials. Participants will also feel more comfortable with a diverse group of investigators

working on clinical trials.

 

• Decentralized Clinical Trials(DCT): This enables the use of technology to facilitate remote forms of clinical trials.  Participants from anywhere in the world can take part in the process. Some DCTs may require patients to visit a nearby pharmacy or clinic to submit data, while others allow patients to enter data themselves into their app or device.

 

• Reassess Inclusion/Exclusion Criteria: Companies should review their inclusion criteria carefully to ensure that potential participants such as the elderly, people with chronic illnesses, people with disabilities, or obese patients are not excluded from the criteria, as they are likely to benefit most from the study. This would indicate how the product will work for them.

 

• Use an interpreter: For participants who may not speak the same language as the researcher, using an interpreter to fully explain the research is helpful to ensure informed consent. Translation of the consent form into a language the participant understands should also be considered.

 

• Include clinical trial sites in multiple continents/ countries: There should be trial sites in multiple continents. Like in Africa, which is one continent that has fewer clinical trials than its western counterparts. Several companies are starting to do more clinical trials in Africa.  Infiuss Health is an example of companies that aims at bridging the gap between researchers and participants in Africa. This will slowly lead to a greater representation of African participants and enhance diversity.

 

Conclusion

 

For patients to receive the safest and most effective therapy, clinical trials must be carried out with diverse participants, including patients from different parts of the world.

 

Infiuss Health is committed to increasing participation, particularly by Africans and other minorities, in clinical research. It also serves to ensure trust between the investigators and the participants.