Technology today can provide benefits and opportunities for clinical trial participants and sites alike, improving efficiency, accuracy, and engagement.
Experts across the industry agree that for solutions to be effective and adopted, they need to address specific problems, as well as meet and exceed the expectations of users. For example, participants today expect flexibility, including the option to use their phones or other digital devices to complete trial activities, track symptoms, schedule on-site visits, and receive payment for their participation. Sites reinforce the value mobility can provide; according to the newly released Greenphire Patient Convenience Market Trends Survey, 86% of sites said it is important to provide clinical trial participants with the ability to access their study information digitally. However, the ability to provide this value add cannot come at the expense of site staff.
In this article, we explore this topic further, answering key questions regarding how we can enable patient engagement with a critical eye on supporting sites.
It is a fair question given the nuance and many hands involved in successfully ushering a clinical research from recruitment to close-out. There are many technologies that clinical sites use over the course of the study, either provided by sponsor, CRO, or purchased. We believe that technology has the power to streamline trial workflows from beginning to end, with the ultimate objective of evaluating drug efficacy and safety so treatments are put in the hands of those who need them, faster.
In particular, mobile technology offers many of the same benefits that it has had to other industries and global markets: ease of use, convenience, and interaction – interaction arguably being the most important component.
Improving patient recruitment, retention, and overall experience is a top priority for clinical research sites as patient dropout is a significant and persistent challenge they face. Patient engagement solutions have emerged as a key way to retain participants, and the development of new mobile technologies such as Greenphire’s participant-facing application, GreenSpace, have the power to dramatically improve study results. Additionally, these solutions make quick work of historically tedious paper-based tasks which can be labor-intensive and potentially error prone for both site staff and participants alike.
Technology and convenience are two items that people often associate together. Adding the purpose of increasing patient engagement by incorporating new technologies and services based around participant experience can create improved accessibility. Research has shown that 70% of potential clinical trial participants live two or more hours from the nearest trial site. Additionally, sites are under increased scrutiny to improve study diversity; the Center for Information & Study on Clinical Research Participation validated in their 2021 Perceptions and Insights Survey that underrepresented communities (respondents who identified as Black and/or Hispanic) were more likely to cite the availability of mobile apps as important compared to White respondents. This further emphasizes the need for mobile technology to help improve retention of all trial participants.
Additionally, mobile technology allows participants and site staff to easily touch base in between in-person visits. It also gives participants the ability to log health information, access educational materials about their treatment and submit any questions they have. This bi-directional flow simplifies communication – an area known of frustration for participants but also difficult for site staff to scale easily and effectively.
While life sciences have been slower to adopt mobile technologies than other more retail industries, it has been with good reason. The convergence of health and personal identifiable information in clinical trials, puts data privacy and information security at the forefront. Mobile technology used by patients must be equipped with the necessary security measures and regulatory requirements, especially in regard to privacy (including GDPR), tax management, and banking. Integral processes and safeguards implemented through validation, security systems, data encryption, and authentication mechanisms can reassure patients of concerns regarding what information they may input or review within the tool, application, or technological solution. Site staff must have confidence not just in the application and their ability to instruct participants on its use, but also the inherent protection of the data which is available within it.
In a recent survey conducted by Florence Healthcare, 80% of sites reported they do not meet their recruitment goals on time. Even with numerous companies offering patient recruitment services, it still remains an issue. Mobile technology has the ability to reach potential participants that aren’t typically targeted, and allows them to connect with others with the same diagnosis to learn about research studies being conducted.
Patient dropout is a key problem faced by research sites (and the industry). Participants often cite the time, travel and out-of-pocket costs associated with clinical trial participation as core reasons for leaving prematurely, all the while, sites struggle with the administrative efforts of managing increasingly complex protocols.
Certainly. Data from veteran trial volunteers confirms the positive impact mobile technology has had on their experience – potentially leading to improvements in the effectiveness of the research program overall. CISCRP polled those who were enrolled in clinical research trials when the pandemic began, and 41% of them said that they were “very satisfied” with the use of smartphone apps. Additionally, when polled in our 2023 Greenphire Patient Convenience Market Trends Survey, 90% of clinical research sites thought it would be valuable for patients to have a singular access point to access study information such as reimbursements, transportation, appointment reminders and more.
However, clinical sites need our help. The 2022 SCRS Site Landscape Survey evidenced that sites (76%) need support from sponsors and CROs in developing stronger and more robust budgets to allow for increased participation in decentralized (or hybrid) trials. Focusing on removing financial and logistical barriers from patient participation can improve retention, and sites agreed with that sentiment (89% [62.7% believed strongly], Greenphire 2023 Patient Convenience Market Trends Survey). By investing more in mobile technology, it is possible to provide more opportunities and improve retention and recruitment of patients for clinical sites in addition to capitalizing on the innovative solutions being developed and provided to clinical sites globally.
By Tanya Kogan, Senior Product Manager, Greenphire