Start with ‘Why’ When Adopting New Tech to Support Hybrid Decentralized Trials

Author: Nicole Latimer, Chief Executive Officer

During the height of the COVID-19 pandemic, clinical trial sites appeared to face an existential threat as the industry discussed “siteless” decentralized trials. Two years later, conventional wisdom recognizes the importance of face-to-face interactions in clinical care and suggests that hybrid decentralized trials will grow faster [1] and be more prevalent [2] than fully decentralized ones. For sites, however, the rise of hybrid decentralized trials introduces another challenge: the adoption of new technologies. 

Why should sponsors consider hybrid decentralized trial technology adoption at sites?

The benefits of hybrid decentralized trials for sponsors are numerous, including greater patient diversity [3], more timely availability of data [4], more accurate data [5], and reduced study costs [6]. Using electronic patient-reported outcomes (ePRO) as an example, sponsors have real-time visibility into patients’ experiences and confidence in data accuracy through auditable  time-stamped data entries. In addition, since ePRO eliminates data transcription, monitoring, and verification activities, sponsors reduce the costs associated with collecting patient-reported outcomes (PROs). However, realizing these benefits depends on the successful use of and patient introduction to technology by sites.

In this article, I will focus on the adoption of new clinical trial technology and explore how sponsors can support sites as they select and implement technologies. I also will continue to use ePRO as an example, given that 65 percent of sponsors [7] and 56.6 percent of sites already have experience with ePRO [8]

How can sponsors reduce the burden of hybrid decentralized trial technology for sites?

To reduce friction for sites as they introduce ePRO technology, start with establishing an ecosystem to support that change. 

Hybrid decentralized trial technology has the potential to transform [9] the way we think about clinical trials and the data those efforts produce – but when is it the right time to introduce this newer technology? It isn’t a question of what the tech can do but whether the ecosystem can support that change. 

Sponsors can ease the way for clinical trials to enjoy all the benefits of hybrid decentralized trial technology by taking the following steps to ease the burden of adoption for their sites.

  1. Start with ‘Why’

At Medrio, we see ePRO technology leveraged successfully across a variety of patient data collection scenarios. Dosing diaries are a common use of ePRO, especially for complex or confusing dosing regimens. Rather than relying on patients to remember which days they need to take two pills rather than just one, automated reminders through ePRO can jog patient memories, increase patient adherence, and ensure accurate data capture. Quality of life or functional status surveys, which measure daily changes in patients’ experiences, are also commonly administered through ePRO. The real-time visibility into the patient experience, rather than only end-of-study analyses of PROs, provides sponsors with opportunities to adapt and refine studies and provides sites with a better understanding of what is happening with patients when they are not in the clinic. 

Because ePRO can be used differently in each study, sites need to understand the relevance of the information collected through ePRO and how that data impacts the study. While there is no doubt that sponsors include this information in site training, the increasing complexity of clinical trial protocols means that the specific use of ePRO, the patient data to be collected, and the use of that data can all be overshadowed by the other protocol training information. Sponsors can best help sites by ensuring that sites understand the relevance of how patient data will be used, as sites will leverage that information to instruct patients.

  1. Drive technology introduction to patients

Sites are craving training and materials to assist them with introducing ePRO to patients, as evidenced by the recent Society for Clinical Research Sites (SCRS) survey [10]. Because ePRO has versatile uses, sites often cannot recycle training materials from previous studies even when using the same ePRO system. Moreover, sites typically use various ePRO systems across their studies, as dictated by different sponsors and CROs. A 2020 study by Tufts CSDD [11] showed that biopharma companies use anywhere from 1 to 6 unique platforms, with most using 3 to 5 different systems in their clinical trials. Each ePRO system requires patient training on how to access assessments and study-specific information about the data patients are asked to collect. Consistent technology helps sponsors provide participants with regularity, thereby reducing the burden for both the patients who need to learn the systems and the staff who need to train them.

  1. Offer adequate training for sites

According to the 2021 Site Landscape survey published by the SCRS [12], sites need greater assistance in adopting new technologies to support hybrid decentralized trials. When asked about additional support required for hybrid decentralized trials, sites suggested seven needs related to technology adoption, including:

  1. Technology adoption guidance
  2. Patient technical support
  3. Patient training materials and resources
  4. Integration and consistency of technology
  5. Assistance with regulatory requirements
  6. Site personnel training
  7. Site technical support

These needs translate into additional training being required. Among the 62 percent of sites that responded that more training is needed when hybrid or decentralized trial technologies are incorporated, the average increase in training time per trial per month was 17.5 hours [13]. For a typical phase II trial lasting 16 months, sites spend 280 hours or seven full-time working weeks on technology-related training. When 29 percent of sites report negative or razor-thin net profit margins, their frustration with and reluctance to adopt hybrid technologies is understandable [14].

  1. Select an intuitive ePRO system

Not all ePRO systems are equal when it comes to usability. Many ePRO systems require extra effort for both sites and participants. Systems that require dedicated hardware force sites to create processes to store, distribute, and replace lost or damaged smartphones or tablets. In addition, sites need to spend time teaching patients how to use the dedicated devices, instructing them on basics like turning on the device and the specifics of correctly completing surveys. Other app-based ePRO systems require sites to teach patients how to access an app store, search for the correct application, download it, open it, and register. Should an update be made to the app during the course of a study, sites need to teach patients how to download the update. These steps are cumbersome, as demonstrated by the fact that within 90 days of a new activity, approximately 71 percent of app users, across all app uses, are estimated to disengage [15].

The best practice in patient usability is a cloud-based ePRO system. In a cloud-based system, patients receive a text or email on their own devices that contains a link to the ePRO surveys. Patients only need to be taught to click the link to access the system and complete the surveys. Sites do not need to serve as technology help desks by teaching patients how to turn on devices, download apps, or update apps. Instead, sites spend their time with patients ensuring that they understand the importance of accurately collecting PROs.

  1. Use video to foster patient knowledge

In hybrid decentralized trials, sites typically provide patient instructions about ePRO during face-to-face meetings when patients are in the clinic. Unless there is a standard script for the patient training, these face-to-face sessions create variability in how ePRO is introduced to patients. Staff members may present the data differently, and even the same staff member will vary their presentation of the information when repeating it multiple times. During these sessions, patients’ attention levels may vary depending on how much data they hear from staff versus being asked to read themselves. Research has shown that patients forget up to 80 percent of medical information immediately after receiving it [16]. While we support continued interaction and engagement between the site and patients, in my experience, the best practice to increase patient engagement and consistency of information presentation is to introduce ePRO to patients via video. The video should demonstrate how patients access the system, such as an example of a text with a link. The video should also show each survey, discuss why the patient-collected data is important, and explain how patients can complete the data fields. 

On the patient comprehension and engagement front, video surpasses other forms of communication. When compared to reading text, 80 percent of patients would rather watch a video [17]. On the consistency front, a single video provided to every patient eliminates the variability inherent in face-to-face instruction sessions. Although site staff may still follow up with patients to answer any questions they may have after watching the video, video instructions should reduce the time sites spend on patient ePRO training. 

  1. Reinforce key information with concise, printed materials

The widespread availability of the Internet and the ease of searching for information have reduced the recall rate of information and replaced it with the recall of where to access it [18]. For sites that provide only verbal training on ePRO, patients are more likely to contact the site with any question or issue. Printed materials that reinforce verbal information give patients easy access to the information they need [19].

While text may not be most patients’ preferred mode of instruction, printed materials can reinforce critical concepts for patients. These printed materials should be concise, requiring no more than one page. These materials should also liberally use screenshots from the ePRO system so that patients can follow along with the instructions. Critical information for these printed materials includes instructions on how to access the system, why, how, and when a patient should complete surveys, and who patients should contact if they have questions. 

In recent hybrid studies at Medrio, sponsors have seen value in posting this printable content in our MyMedrio portal, alongside a news feed about how the study is progressing and other information that patients may need. By embedding this tool within the overall solution, patients are more likely to engage with the technology leading to improved study adherence. 

  1. Assist with Compliance Monitoring

Finally, support staff with compliance monitoring. In my conversations with sponsors, it is clear that the value of ePRO stems from real-time information about patients’ experiences. But the value of that data is dependent on its quality. Intuitive systems and automated reminders facilitate patient compliance with ePRO, but sites are often asked to play a role. To ensure the highest quality data possible, sites are expected to monitor patient compliance with ePRO and to intervene with patients when necessary. These activities can be extremely time-consuming for sites unless they are streamlined.

One best practice is to ensure that sites have access to real-time exception reporting on patient compliance. The report should be built into the ePRO system, where it is easy for site staff to access and only provide the necessary information for non-compliant patients. Based on when patients should complete their ePRO surveys, the report should be scheduled to run to allow time for intervention if necessary. For example, if patients are required to enter dosing information every morning, the exception report should run at noon. Site staff then can follow up with non-compliant patients in the afternoon to ensure that the morning dose is correctly recorded. 

Moving Forward with Hybrid Decentralized Trial Technology

Anytime you adopt new clinical trial technologies, there will be some burden as sites and investigators learn the new systems – but that doesn’t mean you should delay your adoption. Hybrid decentralized trial technology plays a vital role in today’s clinical trials. It improves monitoring and helps ensure compliance while improving patient engagement and introducing new agilities that help avoid trial delays.

Medrio ePRO is an intuitive patient data collection tool that can help your company enjoy the benefits of an ePRO system while minimizing burden and complexity. In addition to providing strong customer service and a team of dedicated professionals to help you deploy ePRO for your studies, Medrio ePRO also offers seamless EDC integration so your team can get cleaner data faster. To get started, request a demo.


References

  1. Davies, N. (2021, Oct 21). How biopharma and CROs can create value in a shift to decentralized trials. EY. Retrieved 27 Sep 2022.
  2. Miessler, J. (2021, Dec 6). Hybrid Trials May Overtake Traditional Studies in 2022, New Data Show. CenterWatch. Retrieved 27 Sep 2022.
  3. Goodson, N., Wicks, P., Morgan, J. et al. (2022, May 5). Opportunities and counterintuitive challenges for decentralized clinical trials to broaden participant inclusion. Nature npj Digital. Med. 5, 58 (2022). 
  4. Burrows, A. (2021, Jul 5). REPORT: Impacts of Decentralized Clinical Trials 2021. InformaConnect. Retrieved 28 Sep 2022.
  5. Jose, N.C. and Langel, K. (2010, Jun 1). ePRO vs. Paper. Applied Clinical Trials 06-01-2010, Volume 0, Issue 0. Retrieved 28 Sep 2022.
  6. Miseta, E. (2022, July 28). Tufts Finds Substantial Net Benefits To Using Decentralized Trials. Clinical Leader. Retrieved 28 Sep 2022.
  7. Lamberti, M.J., Smith, Z., Dirks, A., Caruana, T., Mitchell, T. & Getz, K. A. (2022, July 27). The Impact of Decentralized and Hybrid Trials on Sponsor and CRO Collaborations. Applied Clinical Trials. Retrieved 27 Sep 2022.
  8. Lamberti, M.J., Smith, Z., Dirks, A., Caruana, T., Mitchell, T. & Getz, K. A. (2022, July 27). The Impact of Decentralized and Hybrid Trials on Sponsor and CRO Collaborations. Applied Clinical Trials. Retrieved 27 Sep 2022.
  9. Adner, R. & Kapoor, R. (2016, Nov). Right Tech, Wrong Time. Harvard Business Review. Retrieved 28 Sep 2022.
  10. Bechtel J, Orvin C, Falcone L, Venn K (2021, Oct 2). The 2021 Site Landscape. Society for Clinical Research Sites. Presented at the Site Solutions Summit.
  11. Tufts, (2020). Impact Report: Drug Developers Respond to Evolving Clinical Data Demands With New Strategies, Tactics. Tufts CSDD March/April 2020;22(3). Retrieved 28 Sep 2022.
  12. Bechtel J, Orvin C, Falcone L, Venn K (2021, Oct 2). The 2021 Site Landscape. Society for Clinical Research Sites. Presented at the Site Solutions Summit.
  13. Bechtel J, Orvin C, Falcone L, Venn K (2021, Oct 2). The 2021 Site Landscape. Society for Clinical Research Sites. Presented at the Site Solutions Summit.
  14. Bechtel J, Orvin C, Falcone L, Venn K (2021, Oct 2). The 2021 Site Landscape. Society for Clinical Research Sites. Presented at the Site Solutions Summit.
  15. Amagai, S., Pila, S., Kaat, A. J., Nowinski, C. J. & Gershon, R. C. (2022, April 26). Challenges in Participant Engagement and Retention Using Mobile Health Apps: Literature Review. Journal of Medical Internet Research. Vol 24, No 4 (2022): April. Retrieved 27 Sep 2022.
  16. Kessels R. P. (2003). Patients’ memory for medical information. Journal of the Royal Society of Medicine, 96(5), 219–222. Retrieved 28 Sep 2022.
  17. O’Neill, M. (2015, May 7). The 2015 Video Marketing Cheat Sheet [Infographic]. Animoto Blog. Retrieved 27 Sep 2022.
  18. Bechtel J, Orvin C, Falcone L, Venn K (2021, Oct 2). The 2021 Site Landscape. Society for Clinical Research Sites. Presented at the Site Solutions Summit.
  19. Badarudeen, S., & Sabharwal, S. (2010). Assessing readability of patient education materials: current role in orthopaedics. Clinical orthopaedics and related research, 468(10), 2572–2580. Retrieved 28 Sep 2022.

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