When patients participate in clinical trials, there is the promise their participation could help all of us live longer, healthier lives by playing a critical part in bringing a new treatment, vaccine, or device closer to FDA approval. But clinical research also has the potential to provide participants with a novel care option if they are living with chronic diseases that are the focus of new research. Unfortunately, patients who might benefit directly are too often unaware that clinical trials are happening in the first place.
The current clinical trial landscape
In 2020, 41% of Americans reported not knowing anything about clinical trials or their potential as a treatment option. That’s a huge percentage of the U.S. population that isn’t participating in research that could help them address serious health issues they’re facing. To correct this, we need an ecosystem-wide effort aimed at building awareness for patients, their advocates, and physicians.
Essential to this effort is a concerted, intentional approach to increase clinical trial access for communities historically underrepresented in clinical research. While there are currently 24,602 clinical trials recruiting participants in the U.S., 50% of FDA trials are conducted in only 1-2% of zip codes in the U.S., which means that millions of patients are shut out of research based solely on their geographic location or socioeconomic status. This primarily impacts people of color and those living in rural communities.
Benefits of clinical trials
It’s a status quo begging to be reimagined. Drugs can have a different effect on patients depending on their race and ethnicity, which emphasizes the importance of increasing diversity in trial participants to ensure safety and efficacy of therapeutics. And, even though every American who has taken over-the-counter or prescription medications has benefitted from a clinical trial, only 8.9% of us report being asked to participate in one.
Beyond the benefits to drug development, participation in clinical trials can provide participants with important advantages too. Patients can gain access to new treatments before they become widely available. They also receive regular, careful medical attention from physicians and other care professionals on the trial’s research team.
For some patients, participation can result in cures; one recently reported trial that evaluated a colorectal cancer treatment remarkably led to remission for every patient involved. Other recent trials have helped shrink tumors for patients with bile duct cancer and provided relief for those dealing with chronic depression. But clinical research provides no benefits if patients don’t know about them – and before we solve the participation challenge, we have to solve the awareness challenge.
Building networks has far-reaching effects
To raise awareness of clinical trials and encourage involvement, we must start by expanding the network of potential clinical trial sites and physicians who administer them. Too often, the community health centers that serve over 30 million Americans – including many members of the underrepresented groups that biopharma companies are seeking to reach and include – are simply left out of the equation.
A positive step forward would be to build up a new, expansive and inclusive network of trial sites and clinical trial investigators who can more effectively bring clinical research as a care option to their patients and communities. No one company can do this alone, but, as an industry working collectively, this is an achievable goal.
Additionally, digital technologies can be used to identify and provide information on clinical trials to people with particular diseases who may benefit most from trial participation, regardless of location. These technologies can also be leveraged to assist in communication throughout the trial process in order to enhance site design and patient experience, helping to boost engagement and prevent dropouts.
Too many Americans don’t know enough about clinical trials to evaluate and choose participation, but we can take steps to solve that problem. We can work together across disciplines to identify and create sites in underrepresented communities, involve new physicians more directly to reach patients and encourage their involvement, and seek patient engagement and feedback throughout the trial process to enhance their experience and encourage future participation more effectively.
By empowering new communities to join in on clinical research, we can reach more patients to offer clinical research as a care option – and at the same time, enlist their help in creating more effective, safer medicines for those who will need them to live longer, healthier lives.