DT’s Clinical Trial Digital Tracker, Q1 2022
The State of Digital Technology Adoption by Clinical Trial Sites
DT’s first two Clinical Trial Digital Trackers, from Q1 and Q3 2021, indicated that the COVID-19 pandemic was catalyzing the rapid adoption of digital technologies by clinical trial sites. This is in line with the significant annual growth of digital health technology use (18%) and decentralization of clinical trials (7%) expected over the next ten years.[i] Our third tracker, fielded in December 2021 and January 2022 and encompassing all global interventional studies launching between March and September 2021, continues to monitor how many active research sites use digital technologies; the digital tools they’re adopting; which tools deliver the best results; and what challenges sponsors and investigators face in integrating digital into their operating models. To monitor progress over time, we recontacted all clinical trial studies initiating prior to March 2021, including our previous respondents, to understand what they would have done differently in terms of digital adoption to improve the success of their study. We found that:
- The number of trials is no longer increasing; most studies are still recruiting. Our second tracker found that the number of clinical trials initiated in each quarter was steadily increasing. The latest data, covering the last two quarters of 2021, indicates that the momentum observed during the COVID-19 pandemic has slowed (see Figure 1). Among studies that initiated before March 2021, 56% are still actively recruiting; 21% have completed successfully; and 13% have moved on from the recruiting phase (see Figure 2). Only 4% of studies were interrupted and 4% discontinued.
- Clinical sites use far more digital tools, but mainly to support internal operations. Our 2021 trackers found a significant increase in digital technology adoption, from 57% to 67%. The latest survey shows an even sharper increase: a staggering 81% of respondents said that they use digital tools (see Figure 3). Of respondents who use digital tools, 58% use them for patient recruitment; 47% to support clinical trial processes not directly related to patients; 38% for patient adherence; and 26% for patient retention. The increase is primarily due to greater adoption of technologies that do not directly support patients.
Figure 1: The number of new clinical trials being initiated is no longer increasing
Figure 2: More than half of clinical trial sites initiating their research before March 2021 are still recruiting
Figure 3: The percentage of clinical trial sites using digital tools is increasing sharply
The Adoption of Non-Patient-Facing Technologies is Increasing SharplySeveral digital approaches to help manage participants’ data and directly support their experiences have recently come on the market. One example is eSource, which includes technologies like electronic patient-reported outcomes (ePROs) and electronic clinical outcome assessments (eCOAs) that collect data directly from patients and clinicians. These technologies ensure data reliability, as they bypass the need to integrate data from other sources, are interoperable, and use and share data rapidly to support real-time evaluations of trial progress. Virtual methods for treatment adherence, remote monitoring, and telehealth to support trial participants who are unable to physically attend an investigation site or clinic are also seeing rapid adoption. Despite these developments, it’s not clear what challenges are associated with new participant-facing technologies and how widely they’ve been adopted. Our tracking data shows that, in the past six months, clinical trial sites:
- Have adopted more EDC and CTMSes but fewer patient-facing tools. When we asked sites using digital tools which ones they’re using or plan to use in their trial, the top three were electronic data capture (EDC) systems/electronic case report forms (eCRFs), recruitment channels, and clinical trial management systems (CTMSes) (see Figure 4). More clinical trial sites are adopting EDC, CTMS, and digital platforms for regulatory planning, submission, and query management than in Q3 2021—just six months ago. The percentage of respondents using digital tools to support adherence decreased by ten points; most other directly patient-facing technologies exhibit a similar downward trend. The adoption of content authoring platforms and real-world data and evidence (RWD/RWE) tools for patient retention remained very low.
- Use the same poorly rated digital recruiting tools. Sites’ primary digital recruitment channels are websites, social media, and email—at levels similar to the previous trackers (see Figure 5). Very few use RWD/RWE resources for recruiting. While digital recruitment channels are the second most used technology, 37% of users said that they weren’t very helpful in supporting the trial process—a fate shared by most of the patient-facing technologies (see Figure 6). In contrast, internal capabilities all rated higher: more than 80% of those using EDC/eCRF, the most used technology, said that it was very likely to enable successful trial completion.
- Face interoperability issues and strict staff training requirements. The top three challenges related to deploying digital tools are the same as in the last tracker: finding the right digital tools, the ability of patients to use digital tools, and the cost of these tools (see Figure 7). The percentage of respondents saying that the lack of compatibility with current IT systems is an obstacle to adopting new technology increased sharply, from 16% to 27%, putting it among the top challenges. The increase in respondents citing stringent staff training requirements as a limiting factor, from 10% to 16%, is a trend to watch, as it affects how sponsors must think about allocating time to this activity.
Figure 4: Clinical trial sites are shifting their focus from patient-facing tools to internal digital technologies
Figure 5: The use of real-world data or evidence for participant recruitment is still limited
Figure 6: Pharma firms most often use EDC/eCRF solutions to improve clinical trial processes and rate them highly
Figure 7: Concern about patients’ ability to use digital tools is still a top challenge to digital technology adoption
Clinical Ops Must Address Expectations And Needs of Sites And Participants
DT’s third Clinical Trial Digital Tracker found an upward trend in digital technology adoption, mainly to boost behind-the-scenes technical capabilities. To address key challenges and make further progress in digital maturity to enable great experiences for trial participants and clinical sites, pharma firms should:
- Focus on adopting more fit-for-purpose patient-facing digital tools. Clinical trial sites’ use of digital technologies like ePRO, virtual consultations, patient communication channels, patient experience platforms, and remote monitoring tools isn’t increasing—and in some cases is even decreasing. While these tools strengthen participant retention, sites don’t always employ them in clinical trial journeys.[i] The last two trackers found that trial sites are increasingly concerned about patients’ ability to use digital tools; it’s now evident that this is a chief obstacle to digital adoption. To resolve the issue of patients’ physical inability to use certain digital tools, pharma companies can uncover the required patient insights and solutions through surveys and patient interviews at the study design stage. In the same way, firms can orient site selection, startup, and feasibility toward the careful and appropriate integration of patient-facing tools.
- Rethink the intent of decentralized trials. Decentralized approaches to clinical trials are top of mind for and the goal of most, if not all, pharma research clinical ops teams. Such approaches do have significant benefits: they improve patient inclusion and diversity; data collection and use; and patient recruitment, retention, and overall experience. But before implementing any technologies, firms must listen to what clinical trial sites and participants have to say about what they expect from decentralization and what they think the challenges are. Primary factors driving trial participants’ willingness to stay until the end of a trial are communication with researchers and healthcare professionals; clarity on the progress of the research; and the empathy of research and medical staff. Firms looking to transform clinical trials with decentralized technologies and operating models should consider these factors first, especially when designing best practices for decentralized capabilities and factoring in sites’ challenges. Otherwise, they run the risk that any improvements will be minor and not justify the significant investments made.
- Prioritize data interoperability. The sharp increase in the use of digital technologies in clinical trials, including decentralized approaches, eClinical solutions, and eSource, means that clinical ops teams need to prepare for a different level of data management. To stay competitive, teams must stay on top of unprecedented volumes of patient data coming from a variety of sources and in real time. Maintaining data interoperability across stakeholders and the compatibility of IT platforms and system with those of sponsors are significant challenges and can limit study feasibility, site selection, and startup. Firms can best address rising concerns about data complexity and IT interoperability by hiring the right talent, such as dedicated clinical data managers, and producing specialized training aimed at both current staff and clinical trial sites. To ensure that stringent training requirements don’t become an even bigger challenge, pharma companies need to update training facilities and materials and design flexible, user-friendly approaches.
The DT Clinical Trial Digital Tracker Survey, Q2 2022 was an email-initiated online survey based on the database at www.clinicaltrials.gov. The survey covers 3,343 global industry-funded interventional studies that launched between April 1, 2021 and October 31, 2021 and were actively recruiting participants. We recontacted sites included in the previous survey—2,933 global studies launched between October 1, 2020 and March 31, 2021—and received a total of 450 responses, 45 of which came from previous respondents.
DT Consulting contacted principal investigators via email in December 2021 and invited them to participate in the survey. Please note that respondents who use online networks, are triggered by email, and participate in online surveys have more digital experience and are more likely and confident to interact with companies digitally than those with less experience.
Tim van Tongeren