CEO, Sickle Cell Reproductive Health Education Directive

Teonna Woolford

Historically, the medical establishment hasn’t treated people of color well. Not only do we experience persistent trust and transparency challenges, we have also been left out of clinical research, where the consequences of underrepresentation are far-reaching. It means that too often, drugs are developed for patients who live near or can easily travel to research sites; right now, 

 are conducted in two percent of US zip codes. Black people comprise only 

 of participants in trials, which tend to be conducted in white, affluent 

People like me who are living with sickle-cell disease face limited access to trials, which results from distance and a lack of awareness. In rural areas we have sickle cell warriors who must travel three-hours-plus to get to a trial center. Travel time, costs of gas, and parking are daunting—as are missing work and having to find and pay for childcare.

If companies want to create drugs that are developed to be effective for a wider range of patients, decentralized clinical trials (DCTs) present a promising path forward. Cast largely in a virtual setting, they make research more accessible, creating opportunities to expand and diversify the pool of patients involved in clinical science.

But for DCTs to live up to their potential to drive more equitable, inclusive research, trial designers and other stakeholders need to engage with communities of color more openly and transparently. They must also take part in an industry-wide conversation in which patients become partners and their concerns are truly heard through collaboratives, such as the Decentralized Trial Research Alliance (DTRA). In an address before the DTRA’s fall meeting last year, I outlined how industry can begin to build DCTs so that more people of color take part and, consequently, drugs are better developed for the patients who need them most.

DCTs began to proliferate during the COVID lockdown. Conducted via remote technologies, their convenience and the ease of access they enable are good first steps to driving better equity in drug development. But we must overcome some digital hurdles. A study I participated in required an app on my smartphone; researchers take for granted that everybody has a smartphone or tablet and Wi-Fi. If trials require communications technology, then designers must close the digital divide, providing needed tech to make sure patients can participate.

But a bigger barrier must be addressed: establishing trust. My first experience with research was 11 years ago and provides an example of the challenges facing participants that DCTs need to consider and overcome.

I needed a bone marrow transplant. I felt defeated from being hospitalized from sickle cell every two weeks. My complications included having both hips replaced by 15 and liver failure. After a year of waiting for a perfect match, I was urged to join a trial by one of my hematologists, who said, "you’re running out of options." A sunny picture was painted for me about why I should do it; risks were glossed over but my quality of life was about to drastically change for the worse.

The severe physical impacts of the trial were nothing compared to the mental toll it took on me and my family; 11 years later, I'm dealing with consequences that nobody prepared me for. That's how I began advocating for mental health support and better informed-consent processes. DCT trial designers take note: if an advocate had walked me through informed consent to understand what these decisions were going to mean years later, I might have made different choices. Informed consent is too overwhelming to be fully virtual and requires frank, face-to-face conversation to ensure participants can ask questions and fully understand the process.

Trial managers should think outside of the box to establish trust, meeting prospective candidates not only in doctors’ offices, but also in churches or other places patients feel safe. Investigators should offer support from sources including social workers and psychologists. I am passionate about peer-to-peer connections; hearing someone else’s experience can foster peace of mind and make informed consent easier and more open. HIPAA and compliance requirements may need to change to allow that.

Another great way to build-up trust is to invest in patients’ disease communities. In sickle cell, we have trusted community-based organizations, and by partnering with them, drug companies will leave patient populations in a better position than when collaboration began.

In research, clinicians don’t always do a great job of being transparent or managing expectations. That happened with me; it’s happened with a lot of people of color. But with DCTs, we have a chance to change that by fostering honesty and transparency so patients don’t feel like guinea pigs. We must involve patients as collaborative partners in trial design from the very beginning, not just bringing them into the trial when It’s already all together.

DCTs are promising because they can more readily lower barriers to participation for patients from communities of color. But to realize the benefits of more equitable drug development, trial managers must go further and treat patients as partners.

, CEO, Sickle Cell Reproductive Health Education Directive

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