Life science companies are dependent on clinical research to improve our knowledge of life-altering diseases, develop better diagnostic methods and design new treatments or medical devices to ensure better patient care. While it may sometimes seem that such research proceeds at a dizzying pace – consider the development of COVID-19 vaccines, for example – the unfortunate reality is that researchers often encounter lengthy delivery delays, primarily linked to study enrollment. In fact, 80 percent of global trials do not enroll on time. In some cases these delays turn into terminations, causing frustration as well as financial losses. The industry is rightly seeking ways to overcome enrollment blocks.
Understanding low enrollment
Each study is different, of course, but some of the most common obstacles to timely enrollment include:
- Lack of awareness. Potential participants usually don’t know about clinical trials being conducted for their health conditions unless their physician personally brings it to their attention. The problem is worse in regions and cultures with low literacy levels, according to a 2020 article published in Perspectives in Clinical Research.
- Logistical barriers. In order to participate in a trial many potential participants in a clinical trial must consider the time and cost impact of participation such as transportation, time away from work or family obligations, child care, and other considerations.
- Concerns around side-effects. Many potential participants are put off joining a clinical trial for fear of the potential side effects or lack of benefit they may experience from the treatment under investigation, especially if there is an alternative treatment available that is part of the normal standard of care.
- COVID-19. The pandemic has created significant challenges in clinical trial enrollment with many potential participants continuing to adhere to social distancing measures and remaining reluctant to return to in person healthcare in order to minimize the potential risk of infection.
- Perceived burden of trial participation Clinical trial complexity. Many potential participants are put off enrolling into a clinical study due to the number of protocol procedures that increases the experiential burden on them as participants. Since 2009, the number of procedures in phase 2 and 3 studies has increased 44 percent, now averaging 263 per patient, to support 20 endpoints per trial.
How technology can help
Sites will always play a crucial role in identifying, screening and enrolling patients in a clinical trial, hence it is imperative that we work with them to understand their needs and use this to build a robust infrastructure, including technology that helps them to identify diverse and underserved communities. Providing site staff with digital tools that help them seamlessly, accurately and consistently characterize eligible patients will help minimize screen failures and ensure potential participants are provided with the right information in an interactive manner that enhances their understanding of the trial and what is expected of them in an effective and compassionate manner. Through the introduction of remote data collection we can also relieve the logistical trial burden on patients which may also help minimize dropouts.
Technology can also help enable stronger partnerships across site networks such as Medable’s Site Network Council, which leverages the power of partnerships to overcome common barriers to enrollment. Such networks can leverage centralized outreach campaigns, recruitment aids and advertising to patient communities more broadly and effectively and can cultivate strong relationships with key research partners.
Making protocols patient-friendly
Clinical research teams should aim to create study designs that measure what truly matters. Every procedure and data collection point should be integral to answering the primary research question(s), and not included as a ‘just-in-case’ measure for the benefit of investigators. By centering the patient’s experience — including what it’s like to live with their disease — at the forefront of considerations, teams can help participants feel engaged rather than overwhelmed.
One way to reduce protocol complexity when sponsors are attempting to answer several questions is to use a master protocol. Combining several sub-studies under one umbrella can reduce administrative costs and start-up times. And, because researchers don’t have to continually replicate infrastructure or capture the same data repeatedly, the trials are more efficient. The benefits of this type of design are already being seen in COVID research worldwide.
Recent advances in technology, like Medable’s Digital & DCT Screening tools, can reduce or eliminate the need for in-person site visits for patients, and can help teams identify qualified patients and reduce screen failures. By incorporating digital recruitment and other remote approaches into study design, we can create a more inclusive trial experience that works for every body and every biology, all while tapping into the power of data-driven technology.
Contact Medable today for a demo.