Clinical Trial Democratization
Inclusion & Patient-Centricity
Enrich Legacy Methods
‘Real-World Data’ Is Transforming Drug Research
For far too long, the clinical trial populations have not reflected the diversity of the real-world population.
A recent study indicates, for example, that slightly fewer than half of clinical trial patient populations include women and that Black patients make up only 7% of trial groups. More than 75% of trial participants, meanwhile, are white. Otsuka believes there is a better way, and has persevered in recent years to address this disparity—launching a landmark fully remote clinical trial, in February. Exploring innovative methods, such as siteless, fully remote trials increases the number and diversity of study populations by making it easier for a much wider range of participants to enroll and contribute their health data.
Within the specific context of mental health clinical trials across the industry, indications are that Asian American, Native American/Native Alaskan, Native Hawaiian/Pacific Islander and multi-ethnic patients, as well as members of linguistic minority groups, are underrepresented. Knowledge that emerges from non-diverse trials might not be as relevant to the actual U.S. population as it should be.
That’s why the pharmaceutical industry and research community are making an effort to change how they recruit clinical trial participants. In 2020, both the FDA and the Pharmaceutical Research and Manufacturers of America released documents advocating for diversifying trial populations and offering guidance on how to do it, including by broadening eligibility criteria. The goal is to produce
knowledge that’s relevant to actual demographic conditions: “real-world data.”
Equity in clinical trials is imperative to ensure that individual needs are integrated throughout the entire process from development through commercialization.”
HEAR MORE ABOUT MEETING SOCIETY’S NEEDS FROM CHRISTOPH KOENEN, EVP & CHIEF MEDICAL OFFICER, OTSUKA AMERICA PHARMACEUTICAL, INC.
Ultimately, that data will be to the benefit of patients, paving the way for treatment that comprehends humans in all of their variety, making it that much more effective.
A Key Step In Drug Development Goes Virtual
Taking part in a clinical trial has often meant adhering to rigid schedules and guidelines. Following protocols will probably always be part of the trial experience, but experts are also taking patient needs and preferences more into account. That’s good for both patients and the drug development process: Research has found that failure to “center the patient” in clinical trials—by considering how a trial may interfere with work or a family routine, for example—hinders recruitment and retention.
In the long term, patient-centricity may well have gotten a boost from a surprising source: the pandemic. At first, Covid-19 put numerous trials on hiatus. Stay-at-home orders reduced trial completion rates by up to 23% between April and October 2020. But these negative developments forced the clinical trial environment to adapt quickly. Clinicians went virtual, embracing video technology as a way to make trials work under lockdown conditions. That will be a lasting perk for patients, who have benefited from the ability to participate on their own schedules and from the comfort of their homes.
The next steps forward in patient-friendly trial virtualization are likely to involve, among other things, the use of wearables to record data and the at-home collection of samples, such as blood and urine samples. For patients, this could mean no more struggling to articulate accurate answers to a doctor’s sometimes complicated questions and no more handing over specimen cups to a nurse. The upshot: yet more progress toward an ever more efficacious and inclusive mental healthcare system.
With virtual clinical trials, we are seeing a great example of an inclusive patient-centric approach to a traditional method. There is a great need to find solutions like this across the healthcare journey to ensure that patients always come first.”
CHRISTOPH KOENEN, EVP & CHIEF MEDICAL OFFICER, OTSUKA AMERICA PHARMACEUTICAL, INC
At Otsuka, we defy limitation, so that others can too.
We believe that there is value in every mind and that no one deserves to be marginalized by society’s beliefs and attitudes toward mental illness. We dedicate ourselves to this community and will not rest until the full measure and potential of each mind is realized, through products, programs, policies and advocacy.
To learn more about how we envision the future of mental healthcare, please visit Otsuka-us.com.