Author: MRN
Improving patient access to clinical trials has become increasingly central to the modern research landscape. The exploration of decentralized clinical trials (DCTs) that has emerged post-pandemic, coupled with a push from patient advocacy groups, regulators, and sponsors to drive greater patient access and diversity for studies, has galvanized new and creative ways of reaching more participants.
For people in rural areas or those without access to many of the major medical centers that form the bedrock of clinical research, participating in a study can be challenging. Traveling extensively to a central investigator site can be burdensome, particularly for patients with limited means or complex medical conditions. Collaborating with the medical providers caring for these patients in their communities is key to democratizing clinical trial participation. By working with “trial naïve” sites to establish the necessary support and resources needed to conduct studies, the right clinical site support service and site network can offer new participant pools to sponsors and new avenues for patients seeking treatment.
The Challenge Of Access For Vulnerable Populations
The disparities in both health outcomes and clinical trial access for rural and urban patients have been documented across the pharmaceutical research space. Studies evaluating trial participants have found that rural patients make up a larger segment of study participants compared to their percentage of the general population, and travel farther than urban patients to trial sites.1 The reality that rural patients are, on average, sicker than their urban counterparts underscores the need for more proactive interventions and for more representative clinical trial involvement for these populations.
One of the most straightforward means of improving access to clinical trials for rural patients is to bring these studies into their communities. This shift in trial conduct may also serve to help bolster recruitment, an issue that has been historically challenging for sponsors. According to the Food and Drug Law Institute, more than 80% of clinical trial sites fail to retain enough participants and up to half fail to recruit any at all.2 These challenges are estimated to result in a potential loss of roughly $500,000 – $8M per day3 for drug developers.
Key Elements Of Successful Community-based Programs
Seeing patients in their own environment is key to ensuring a more accessible, more successful clinical trial paradigm. Community-based trial site support services can significantly improve patient access to clinical trials, as well as trial recruitment and retention, through:
- Increased Accessibility: In-home and community based clinical trials sites eliminate or reduce the need for patients to travel great distances to a site, making participation more convenient and accessible for those with limited mobility or transportation options. This can broaden the pool of potential participants and increase enrollment rates.
- Improved Patient Experience: Home healthcare professionals (HCPs) can provide personalized care and support, addressing patient concerns and needs in a familiar and comfortable environment. This can enhance the overall patient experience and improve retention rates.
- Reduced Burden on Patients: By conducting clinical trial visits at home, or at nearby community clinical trials site, the physical and emotional burden on patients is reduced, making it more likely that they will remain in the study.
- Streamlined Data Collection & Integrated Reporting: Home HCPs can collect data and samples directly from patients, reducing the need for multiple site visits and minimizing data entry errors, thereby improving data quality and efficiency. Combined with an integrated eClinical platform, this enables scenarios wherein better data reaches sites faster.
- Enhanced Patient Safety: Home HCPs can monitor patient health and adherence to study protocols, ensuring that patients are safe and receiving appropriate care. This can help to reduce the risk of adverse events and improve patient safety.
These advantages can offer a global solution for trial recruitment, retention, and diversification. Changes that can improve community access could, in turn, also serve to streamline study costs significantly, potentially lowering the estimated cost of patient recruitment, which on average makes up roughly 32 percent of a trial’s budget.4
The Future of Clinical Trials Starts at Home
When it comes to improving patient access, the right partner should possess a diverse network of sites both experienced and “trial-naïve”, large and small, in rural and urban communities, and even doctor’s offices and emergency care sites, as well as virtual resources. Their support solutions should further incorporate significant oversight and management, site training programs, patient recruitment services, patient visit scheduling, and project oversight. Together, these approaches can expedite enrollment, improve monitoring, and help “trial-naïve” sites quickly mobilize to become research ready. Medical Research Network (MRN), an industry leader in home trial support, has amassed the necessary expertise to innovate around these concepts, creating solutions that enable home trial support that is tailored to a trial’s — and a patient’s — needs.
By leveraging advanced technologies, trials can collect real-time data on patient outcomes, ensuring timely interventions and improved adherence; this, combined with integrated site networks backed by dedicated home trial support teams, enable access to a wider pool of qualified patients, accelerating recruitment and enabling more diverse study populations. Finally, home trial support like MRN’s can offer personalized assistance to patients, addressing their needs and concerns, and ultimately improving their overall experience. When these elements work in synergy, trials supported by home health solutions can deliver superior results, reduce costs, and improve patient satisfaction.
Learn more about how to leverage home healthcare and site networks to streamline trials and improve patient experience here: https://themrn.io/solutions/
References:
- Bharucha AE, et al. Participation of rural patients in clinical trials at a multisite academic medical center. J Clin Transl Sci. 2021 Jul 12;5(1):e190. doi: 10.1017/cts.2021.813. PMID: 34849264; PMCID: PMC8596068.
- Food and Drug Law Institute (FDLI). (2024, April). Legal and ethical considerations for offering clinical trial recruitment payments and enrollment incentives. https://www.fdli.org/2024/04/legal-and-ethical-considerations-for-offering-clinical-trial-recruitment-payments-and-enrollment-incentives/
- Smith ZP, Getz KA, et al. New Estimates on the Cost of a Delay Day in Drug Development. Ther Innov Regul Sci. 2024 Sep;58(5):855-862. doi: 10.1007/s43441-024-00667-w. Epub 2024 May 21. PMID: 38773058.
- Deloitte University EMEA CVBA. (2020). Deloitte Insights, Intelligent Clinical Trials. https://www2.deloitte.com/content/dam/insights/us/articles/22934_intelligent-clinical-trials/DI_Intelligent-clinical-trials.pdf