Clinical research participants are not necessarily representative of the populations that will ultimately receive the new therapy, if or when it’s approved. Generally speaking, clinical trial participants tend to be privileged, have the ability to take time off of work, and have access to medical centers. They tend to be, in reality, middle-aged Caucasian men.1
Limiting the scope of research in this way is simply not good science. We need a platform that allows us to expand access to all patients, providing a more inclusionary process for women and minorities.2 We need to test drugs on a diverse, representative population to understand how the biology works in everyone.
The health care industry can better connect with patients as well as ensure broader access to clinical research, better inclusion and diversity, and increased availability of investigational therapies to all by decentralizing the existing research paradigm.
Limitations to the current model
Traditional clinical research is site-dependent and creates a high burden on patients. It requires them to travel to physical sites, resulting in time off of work, time to travel, and other inconveniences.1
The current research paradigm’s limitations and the gaps in accessibility make it challenging for clinical research to reach a representative group of patients.1 This means that potential patients do not receive the care option of clinical research, nor can they participate in science that could save lives.
Barriers for underrepresented patient populations
Participating in a clinical trial is often particularly burdensome for patients with rare diseases. Because the expertise is so specialized, they may need to travel hours — or across multiple states or even countries — to a site where the research can be performed. This creates a burden on the patient and their caregivers and families, who need to adjust their schedules and routines in order to seek treatment. The added cost and time create more challenges and stressors to an already challenging and stressful situation.3
Additionally, language barriers inhibit access to information when looking at underserved populations such as Asian Americans, Latinx, and Pacific Islanders.4 Other barriers to seeking clinical care for these groups and for African Americans include mistrust, competing demands, lack of access to information, and health condition stigma.5
Breaking barriers with patient-centric approaches & advanced technology
We need to increase the number of sites that target these groups in order to increase the diversity of patient populations in clinical trials.6 We can find ways to bring more diverse patients into a trial with the use of technologies such as mobile health platforms. By using a bring-your-own-device approach, patients can get the care they need through familiar devices, right at their fingertips. Regardless of where a patient is physically located, their socioeconomic status, gender, or ethnicity, they can participate in a clinical trial from anywhere. This lowers the barriers of entry and ensures everyone has access to the best possible care.7
PRA’s Mobile Health Platform is making care more accessible to all patients — watch the video below and learn more at PRAHS.COM/MHP.
Engaging & protecting patients with technology
More and more patients have been asking to participate in health care remotely. Covid-19 exacerbated that need, due to site closures and challenges for higher risk populations to receive in-person care. We have seen a sharp increase in modalities such as telehealth visits across disease states. This further highlights the need for research and care options using a decentralized or virtual model. Mobile health platforms specifically answer this need by enabling greater access to patients where they already are.
We’re already seeing technology use change how patients get their health care delivered.8 Clinical research needs to mirror that use. For example, technology allows for the decentralization of clinical trials, thus bringing research directly to patients on their own mobile devices. This allows us to reach a more diverse and representative patient population wherever they are.6 Not only does this help provide access to groups who’ve otherwise struggled with access, decentralized trials will also create better science, and therefore provide clinical trials as a care option for underserved patient populations.
Read more about how decentralized trials and a patient-centric approach can help bridge the diversity gap.
1 Schliebner, S. The Burden of Clinical Trial Participation. Rare Disease Patient Survey, 2018. PRA Health Sciences. Data unpublished.
2 Lovett, L. Clinical trials have a historic gender gap – tech could help. Mobile Health News. https://www.mobihealthnews.com/news/clinical-trials-have-historic-gender-gap-tech-could-help
3 “Standard of Care.” Legal Information Institute, Legal Information Institute,www.law.cornell.edu/wex/standard_of_care.
4 Institute of Medicine (US) Committee on Understanding and Eliminating Racial and Ethnic Disparities in Health Care. Unequal Treatment: Confronting Racial and Ethnic Disparities in Health Care. https://www.ncbi.nlm.nih.gov/books/NBK220337/
5 Getz, K. The Need and Opportunity for a New Paradigm in Clinical Trial Execution. Applied Clinical Trials. 2018. https://www.appliedclinicaltrialsonline.com/view/need-and-opportunity-new-paradigm-clinical-trial-execution
6 Ashford, J. Clinical trials need to include more Black and other minority participants. Here’s how. 2020.
7 Terry, M. Pushing for More Ethnic and Racial Diversity in Clinical Trials. BioSpace 2020. https://www.biospace.com/article/pushing-for-more-ethnical-and-racial-diversity-in-clinical-trials/
8 Miliard, M. AMA sees surge in health IT adoption, ‘rise of the digital-native physician’ 2020. HealthCare IT News. https://www.healthcareitnews.com/news/ama-sees-surge-health-it-adoption-rise-digital-native-physician