By Irene Yeh 

May 6, 2025 | At last month’s Bio-IT World Conference & Expo, Joan Chambers, Senior Consultant at Tufts Center for the Study of Drug Development (CDSS), spoke extensively about the future of clinical trials, particularly on the impact of decentralized clinical trials (DCTs), approaches that improve accessibility and convenience for the trial process, and insights on solutions for patient recruitment and retention. She presented a study that the Tufts CDSS conducted to review how DCT solutions are being utilized, their benefits, and how they can be used to improve patient access to clinical trials. 

Issues with Patient Recruitment and Retention 

Clinical trials depend on patient recruitment, but only 2-5% of US patients are enrolled, and among those participants, 27% of them meet the eligibility criteria, according to Chambers. Though sponsors are increasing focus and efforts to improve recruitment and retention rates, there are still barriers, such as access limitations, indirect costs, and a lack of support for baseline medications. It must be mentioned that every one of these factors disproportionately affects socioeconomically vulnerable populations. 

In the review of the informed consent form used during pre-study experience, volunteers gave their reasons for non-participation. About 54% of volunteers answered that they did not want to deal with the expected burden of participation, 25% cited scientific or study risks, 14% responded that it was a lack of information, and 7% had concerns about privacy and confidentiality. 

Post-study feedback revealed that 30% of participants expressed concern over whether they were receiving investigational treatment or not, 22% reported that the location was an issue, 19% replied that the visits were too time-consuming, 16% stated that they felt there was insufficient compensation, and 15% found the studies too cumbersome.  

How DCT Solutions are Helping with These Challenges 

“Organizations can help alleviate the patient burden by improving the accessibility, convenience, and centralization of the services through different DCT solutions,” explained Chambers. DCTs can help with streamlining operations, offering more efficient scheduling, and providing clearer communication. It may sound simple, but addressing concerns (such as where to find study locations) and making the process more convenient for patients are the keys to enrolling and retaining patients. DCTs can also help with reducing patient anxiety through furthering transparency and fostering higher engagement. 

“The pandemic, if we all remember, accelerated the adoption of various technologies with significant shifts from February 2020 to June 2022,” continued Chambers.  

Several technologies increased during the COVID-19 pandemic. For example, Telemedicine use in studies went from 22% in February 2020 to 57% in March 2021. But by June 2022, it decreased to 37%. Wearable devices went from 39% in February 2020 to 48% in March 2021 and then stabilized at 40% in June 2022. Remote monitoring use in studies went from 43% of trials in February to 70% in March 2021 and decreased to 55% in June 2022. Even home visits and home treatments experienced similar jumps. Home visits were used in 37% of trials in February 2020 up to 61% in March 2021 and decreased to 32% in June 2022. Home treatments surged from 20% in February 2020 to 64% in March 2021 and then down to 29% in June 2022. 

Though still higher than their pre-pandemic counterparts, these DCT solutions were being used less as restrictions were gradually lifted. But why? 

Not a Lot of Hard Data 

The Tufts CDSS team reviewed over 16,500 peer-reviewed articles and journal publications since 2022, and they found that 38% of the articles, especially the post-pandemic ones, focused on more of the conceptual frameworks and the principles for virtual or remote solutions. Upon further investigation, the team learned that there was a lack of empirical data around remote and virtual solutions. Instead, the publications centered around the discussions about the challenges of implementing remote and virtual approaches. 

“Only 6% of the articles really could be considered evidence-based,” said Chambers. “Among these were actually little surveys—or quantitative, rather—than really offering robust general data.” 

The shortage of empirical evidence is not surprising. As Chambers explained, the rapid adoption of technology during the pandemic caused the reassessment of which solutions to use and when. However, without clear ROI, companies turned to investment insights or hard data as a guide in decision-making. Many organizations took a cautious approach to these solutions and the adoption of said solutions. 

Additionally, another root cause is a lack of standardized measurement. There is no “uniform agreement” on what and how to measure what goes into considering the type of solution organizations should use. 

The PACT Consortium 

The Partnership for Advancing Clinical Trials (PACT) Consortium was established to address this lack of empirical data. They began with a baseline assessment in late 2023. Fifteen PACT member companies completed the baseline assessment that revealed several key takeaways. At the time of the survey, 75% respondents considered hybrid DCT use as strategic in nature. Despite the low deployment, there was a high level of expected growth in DCT components. More than 90% saw benefits to patient participation and satisfaction, as well as improved diversity and access. Virtual and remote solutions particularly have a notable impact on patient and participant representation and diversity.  

The key challenges that were identified in baseline assessments were monitoring and demonstrating the return on investment—particularly in understanding deployment costs due to the hybrid and customized approaches—technology validation, the ease of deployment and support, and potential help desk issues at site level that would need to address technical concerns. These challenges contribute to the resistance of implementing DCT solutions.  

Electronic DCT solutions, such as e-consent and remote consent, may support online patient recruitment, yet adoption of them remains low. About 65% of respondents reported the infrequent use of telemedicine, mobile visits, and wearable devices. It must be noted that the participants in this baseline assessment were all pharmaceutical and biotech companies, not sites. 

Furthermore, post-pandemic, DCT experiences were a mixed bag. About 69% of companies rated their experience as fair or poor and 31% rated it as relatively good for the highest rating. No company rated their experiences as very good or excellent, and half the sample pool rated their own company as only having rudimentary DCT management skills. 

“Although the baseline assessment did not show any companies reporting that they anticipate using DCTs for the vast majority of their studies or protocols, we did ask them to forecast usage over the next five years, and we generally see that the expectation for DCT component adoption is there,” Chambers elaborated.  

After the baseline assessment, the PACT team gathered data from January 2024 to late spring 2024, gathering data from 69 trials across 14 companies. The vast majority of the protocols that the sponsor companies submitted have not yet been completed or had their databases locked. About 50% have actually completed recruitment and showed a high percentage of completions in site activations and most of these are ongoing studies.  

Currently, Tufts CDSS is in the process of contacting the companies who partook in this assessment to get updates so that they can expand the dataset and see when these protocols are going to be locked. Tufts CDSS is focused on five primary activities: recruitment, screening, consent, training, and study visits. “The current dataset primarily offers insights into the experiences with study visits with the lower numbers for other study activities and tasks,” added Chambers.  

Study visits were reported to have three specific DCT solutions on average in use, with about 90% focusing on phase 2 and 3 activities. Due to the small sample size, the team was unable to get specific insights into activities by therapeutic area, but Chambers is hopeful and expects that—as it expands—the database will provide specific strategies for DCT solutions and deployment within specific therapeutic areas. Additionally, as time goes on, organizations may adjust planned timelines as they become more familiar with DCT solutions and with applying solutions to certain therapeutic areas and studies. 

The Impact of DCT Solutions 

Among the 69 trials reviewed, it was found that study visits took up 88% of primary tasks or activity areas where DCT solutions were utilized. And in the study visits, it was found that electronic clinical outcome assessments (eCOA) were the most used DCT component, topping at almost 86%. Results also showed that apps for reminders, apps for data collection, telehealth, and websites were also commonly used. 

“Patient recruitment relies on websites or portals while informed consent utilizes websites, portals, and apps for data collection and for reminders,” added Chambers.  

She also mentioned study budgets and how challenging it can be to receive. For many sites, it was found that specific incremental budget is often offset by improvements in access, retention, and recruitment. When DCTs were used, actual timelines were closer or even ahead of planned timelines. However, site activation timeline and study startup timeline were longer, and the actual number of sites activated was actually lower. But when DCTs were used, site performance significantly improved once the study was initiated and the actual timelines exceeded the planned timelines. Additionally, it was found that faster enrollment timelines were associated with a higher proportion of remote procedure. 

Despite the small pool of 69 trials reviewed, the study gave valuable insights into DCT solutions and how they’re being used in clinical trials, as well as their impact.  

Incidentally, the PACT Consortium sample showcased an increased participation from Asian and Hispanic communities. “The ability to be able to collect data on individual patient communities—in this case, by race and ethnicity—allows us to begin to start capturing this data and start capturing this analysis.” It was also observed that patients who were of African descent were more likely to participate in a study if it included a local location or offered improved access. 

Through the efforts of Tufts CDSS and the PACT Consortium, DCT solutions prove that they make a positive impact, but they need to be assessed and implemented correctly. “We are looking at figuring out what to measure, how to measure it, the data volume, and the level of granularity that is needed behind these solutions,” said Chambers.