It is widely known that clinical trials in the United States often lack racial and ethnic diversity, and this directly impacts the quality of healthcare we provide to underserved populations. Early studies of the Alzheimer’s disease biomarker APOE, for example, overstated its impact on health because of an early focus on white men in clinical trials.
This narrow approach slows the pace of developing safer, more effective medicines and leads to greater disparities in our troubled health care system. Today’s rapidly evolving technology offers at least one clear opportunity: to deploy cutting-edge digital tools to improve diversity in trial populations while also reducing costs. The existing array of smart phones, apps, sensor-enabled devices, websites, social media and telemedicine can be used to attract and retain a more diverse participant group. And at the same time move the industry towards lower-cost virtual, or partially virtual, clinical trial paradigms.
Behavioral Health, Interoperability and eConsent: Meeting the Demands of CMS Final Rule Compliance
In a webinar on April 16 at 1pm ET, Aneesh Chopra will moderate a discussion with executives from DocuSign, Velatura, and behavioral health providers on eConsent, health information exchange and compliance with the CMS Final Rule on interoperability.
Potential study participants stay away from clinical trials for many reasons. Out-of-pocket expenses and logistical hurdles are major factors. A study published in the Oncologist found that patients in NIH-sponsored trials traveled nearly 40 miles on average to study sites, an obvious burden for many patients and caregivers that disproportionately impacts low-income and minority participants.
Mistrust of the pharmaceutical industry and the legacy of exploitation – such as the unethical Tuskegee syphilis experiment that assaulted black patients – also contribute. Black patients, for example, made up less than 5 percent of the trials for 24 of the 31 cancer drugs approved since 2015 despite the fact that they make up more than 12 percent of the patient population.
What’s more, because lower-income groups often receive care at community health centers, they do not have access to, or experience with, large urban medical centers where studies usually take place.
Virtual trials, or partially virtual trials, offer a more inclusive alternative and at least a partial solution to reducing the burden of being in a clinical trial. From the outset, aligning outreach through the websites and patient portals of trusted community health centers, health care providers and disease-support networks would help engage potential participants. In addition, linking patients and staff through telemedicine can establish an authentic, human connection with patients who have limited access to tertiary care facilities.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
Monitoring adherence to drug regimes and reporting vital signs and reactions can be managed remotely and at lower cost through new sensor technology and new measurement devices. Smart phone apps can serve as hubs to check blood pressure and other vital signs and relay information to the trial facilitator, so the patient need not worry about arranging travel or leaving home.
To monitor dosing, we can use medicine dispensers equipped with sensors that detect when a pill bottle has been opened or an inhaler squeezed, rather than through more invasive and costly approaches.
All these elements are benefits of lower-cost virtual trials and also serve to improve the diversity of patient populations. These technologies can make it possible to bring more women, younger people, African-Americans, Hispanics and Asians into trials for diseases that disproportionately affect them, such as heart disease, cancer and diabetes.
A bill recently introduced in Congress by Rep. Elijah Cummings recognizes the stark inequity in clinical trials today and calls for studying policy changes, such as trial virtualization, to reduce barriers that keep certain patients from enrolling in government-sponsored cancer trials. If enacted, the bill – named after Henrietta Lacks, an African-American woman who died of cervical cancer in 1951, and whose cells were harvested without her knowledge for medical research- would be a promising step forward.
A number of research institutions are also seeking ways to increase diversity. The nonprofit Lazarex Cancer Foundation is collaborating with University of California, San Francisco on a three-year study to improve cancer clinical trial participation among underserved populations.
For his part, Scott Gottlieb, who was commissioner of the Food and Drug Administration until April 2019, has urged greater diversity in trials. He has also spoken out on the need to enroll more patients in trials closer to where they live and work, a goal that could be achieved with new technology and the move toward virtual trials.
If used mindfully, the latest advances in technology can ease patient hardships, reduce the participant burden and even increase trust. They would create a more comfortable environment in which we can begin to bring in underrepresented populations and reverse the lack of diversity in clinical trials. Technology can lower costs for pharmaceutical firms by reducing personnel and centralizing operations and facilities. This is good science and even better medicine, and would go a long way to ensure historically excluded communities gain equal access to medical progress.
Photo: FotografiaBasica, Getty Images,
