The efficiency of clinical research is far from ideal. Developing a new drug takes 7 to 13 years, and 85% of clinical trials fail to meet their timelines.1 Less than 15% of trial participants are from minority groups, and patient dropout rates can reach up to 30%.1
Though there are many contributing factors to these discouraging statistics, perhaps the most critical is the research’s persistent lack of patient accessibility.
The Widespread Research Accessibility Problem
Patients can’t participate in clinical research if they can’t access clinical research. The two biggest hurdles that most often reduce patient access are knowledge of and trust in clinical research and physical barriers to clinical research.
Patients’ struggles with clinical research are well documented. According to one survey, 41% of Americans know nothing about clinical research and 91% have never been invited to participate in research.2 Of the few who know about trials and are invited to take part, even fewer will participate. Who can blame them? Many patients worry about being used as “guinea pigs,” as they don’t trust that researchers have their best interests in mind. Others are worried about receiving care from someone other than their known provider. If patients don’t know about clinical trials, they won’t participate. Even if patients know about clinical trials, they won’t participate if they don’t feel comfortable doing so.
Patients also won’t participate if they can’t physically reach clinical trials or if they have to spend lots of time at research sites. 70% of studies are conducted at just 5% of sites throughout the world, automatically limiting patient accessibility.3 Most trials also enroll patients who live within 40 miles of sites.4 Forty miles might not seem very far. But, for patients with disease-related limitations, work obligations, family commitments, and other demands, 40 miles might as well be 400. Furthermore, trial designs that require long or frequent in-person site visits also limit patient access, especially for low-income or caregiver populations. For many patients, taking time off work, finding childcare, or covering other commitments is prohibitive to participation.
Patients’ knowledge of and/or trust in clinical research as well as the physical barriers to participation combine to limit research involvement at a large scale — driving up costs, prolonging timelines, hindering diversity, and hurting data validity.
But Wait, There’s a Solution!
If patient accessibility is the primary factor hindering clinical research efficiency and progression, then enhancing access to trial participation is crucial to addressing these challenges effectively.
Enter: optimized trials.
“Optimized trials” is an emerging concept in the realm of clinical research. These hybrid clinical trials are meticulously designed to create the mostfavorablee conditions for both patients and sponsors. For patients, optimized trials provide a seamless, efficient, and comfortable way to engage in clinical research as part of their regular healthcare options. They eliminate many of the traditional barriers to participation, making it easier for individuals to contribute to and benefit from cutting-edge medical advancements. For sponsors, these trials streamline the process of enrolling and retaining eligible, engaged participants, ensuring that studies can progress without the common delays and dropouts that plague conventional trials.
By increasing access to research participation, optimized trials address some of the most significant pain points in the industry. They prioritize patient experience and access, making it possible for a broader population to participate in clinical trials. This inclusivity not only enhances the quality and applicability of research findings but also accelerates the development of new treatments.
How Optimized Trials Increase Patient Knowledge of and Trust in Clinical Research
Patients typically establish trust and rapport with their regular healthcare providers. They feel comfortable and are accustomed to interacting with these individuals and their teams in familiar, easily accessible settings such as doctor’s offices, local hospitals, and pharmacies. Regular healthcare providers also often live in the same communities as their patients, giving them a better understanding of the local culture. This familiarity fosters a sense of security and confidence, which is essential for effective healthcare delivery.
Optimized trials enhance patient awareness and trust in clinical research by enabling them to participate through their known healthcare providers or Healthcare-First sites. “Healthcare-first sites” is another emerging term that refers to hospitals, doctor’s offices, pharmacies, and other healthcare facilities where patients routinely seek care that serves as research sites with the support of expert insights, infrastructure, training, and technology.
Since most patients rely on their healthcare providers for information about clinical trials, Healthcare-First sites play a crucial role in increasing patient knowledge about research opportunities.2 By participating in trials through their regular providers, whom they trust and depend on, patients are more likely to feel confident and secure in the research process. This approach not only boosts trust in clinical research but also enhances patient engagement and retention.
Moreover, research shows that connecting with patients in their communities is one of the most effective strategies for increasing clinical trial diversity.5 By leveraging Healthcare-First sites, which are embedded in communities and staffed by familiar healthcare providers, it is possible to reach a more diverse patient population, ultimately leading to more robust and applicable medical findings.
How Optimized Trials Overcome the Physical Barriers to Research Participation
Optimized trials’ implementation of Healthcare-First sites also addresses patients’ physical barriers to research participation. Since Healthcare-First sites are situated within patients’ communities, they are inherently accessible. Patients are already accustomed to visiting local hospitals, doctor’s offices, and pharmacies for their regular healthcare needs, which means they don’t have to make additional efforts to participate in clinical trials. This proximity and familiarity greatly increase accessibility and convenience, thereby enhancing the likelihood of patient engagement.
But what about when trial participation is not available through a Healthcare-First site? When a patient doesn’t have preexisting relationships with healthcare providers? Or a patient’s commitments or physical state are too demanding for site visits?
To address these challenges, optimized trials combine the use of Healthcare-First sites with remote research solutions, such as home visits, wearable devices, telehealth, and other technologies. This multifaceted approach ensures that patients can participate in clinical trials from the comfort of their own homes and/or through a local provider, reducing the need for travel and making participation more feasible for those with demanding schedules or physical limitations.
This combination of in-person and remote research options, known as “hybrid research,” prioritizes the patient experience. By offering flexible participation methods, hybrid research supports higher enrollment and retention rates while also promoting diversity among trial participants.
Keep Patients at the Center to Optimize Clinical Research
At their core, optimized trials are all about patient centricity. Unlike other research models that try to fit patient needs into a trial, optimized trials are designed with the patient’s experience in mind, making participation more convenient and comfortable and creating a better process for everyone involved.
And they do benefit everyone! Optimized trials have shown significant improvements in both participant diversity and retention rates. These trials typically achieve at least 30% minority representation, which is double the industry average.1 Additionally, they boast a 27% higher patient retention rate.1
When trials are more diverse, enroll easier, and retain more patients, they move faster. This acceleration benefits sponsors by helping them stick to their budgets and timelines. It also provides research sites with higher revenue and enhanced care options for their patients. Most importantly, faster-moving trials accelerate the development of new pharmaceuticals, biotechnologies, medical devices, and diagnostic products that have the potential to enhance and save lives.
If, at the end of the day, clinical research is for patients, it makes sense that keeping patients at thecentere through optimized trials can only improve the research process. By prioritizing patient needs and experiences, optimized trials create a more effective, inclusive, and efficient research environment. This patient-centric approach ensures that clinical research not only meets scientific and regulatory standards but also addresses the real-world needs of the people it aims to help.
References
- Elligo Health Research. Only Elligo page. Available at: https://www.elligohealthresearch. Com/only-elligo/. Accessed June 26, 2024.
- Health Information National Trends Survey. Hints Briefs Number 48 page. Available at: https://hints.cancer.gov/docs/Briefs/HINTS_Brief_48.pdf. Accessed June 26, 2024.
- GHP News. Community-Based Sites: Casting a Wider Net to Close the Data Diversity Gap in Clinical Trials page. Available at: https://www.ghp-news.com/community based-sites-casting-a-wider-net-to-close-the-data-diversity-gap-in-clinical-trials/. Accessed June 26, 2024.
- Borno HT, Zhang L, Siegel A, Chang E, Ryan CJ. At What Cost to Clinical Trial Enrollment? A Retrospective Study of Patient Travel Burden in Cancer Clinical Trials. Oncologist. 2018;23(10):1242-1249. doi:10.1634/theoncologist.2017-0628
- Igwe JK, Yuthok TYW, Cruz E, et al. Opportunities to Increase Science of Diversity and Inclusion in Clinical Trials: Equity and a Lack of a Control. Journal of the American Heart Association. 2023; 12(24).
Author Details
Dr. Faith Holmes, Chief Medical Officer- Elligo Health Research®; Kristen Snipes, Executive Director, Project Delivery- Elligo Health Research®
Dr. Faith Holmes brings over 30 years of experience in direct patient care and 11 years of medical practice management to her role as Chief Medical Officer of Elligo Health Research. Her diverse background in Family Medicine, and Hospice and Palliative Medicine spans the continuum of the patient journey. Over the last 5 plus years Dr. Holmes has served as Principal Investigator for optimized virtual and hybrid clinical trials as well as at a local research site.
Kristen Snipes leverages extensive experience in drug development and clinical management as Elligo Health Research’s Executive Director of Project Delivery. With a strong background in project management, she brings innovative and resourceful approaches to delivering results in new environments. Snipes offers strategic thinking and problem-solving abilities, consistently adapting to achieve desired goals. She holds a B.A. in chemistry from Colby College and is a Certified Clinical Research Associate through ACRP.
Publication Details
This article appeared in Pharmaceutical Outsourcing: Vol. 25, No.3 July/Aug/Sept 2024Pages: 19-21