February 5, 2023
DT’s Clinical Trial Digital Tracker, Q3 2022
DIGITAL ADOPTION BY CLINICAL TRIAL SITES IS NO LONGER ACCELERATING
DT fielded the first Clinical Trial Digital Tracker in December 2020, less than a year after the outbreak of the COVID-19 pandemic. At that time, nearly half of clinical trial sites (43%) used no digital tools to plan or execute trials. The pandemic had a huge impact on digital tools; their adoption rose from 57% of research sites to 67% in 2021 and 81% in Q1 2022. This is line with other market research showing a 28% increase in the use of decentralized or virtual components in clinical trial processes between 2021 and 2022.[i] One of the main questions for the industry is whether this shift towards digital integration is here to stay or will revert to pre-pandemic levels.
Our fourth tracker, fielded in June and July 2022 and encompassing all global interventional studies launching between October 2021 and March 2022, 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. We also recontacted all clinical trial studies initiating prior to October 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 third tracker found that the number of clinical trials initiated in each quarter was steadily increasing. The latest data, covering the first two quarters of 2022, indicates that the momentum observed during the COVID-19 pandemic has slowed and may be reversing (see Figure 1). Of studies that initiated before October 2021, 53% are still actively recruiting; 25% have completed successfully; and 8% have moved on from the recruiting phase (see Figure 2). Only 4% of studies were interrupted and 4% discontinued.
- Pandemic-related elevated digital adoption is consolidating, but growth is plateauing. In Q3 2022, 80% of clinical trial sites say they use digital technologies—the same as in Q2. Although digital adoption is stable, this is the first time since we launched the tracker in 2020 that it hasn’t increased (see Figure 3). Of respondents who use digital tools, 63% use them for patient recruitment; 40% for patient adherence; 36% to support clinical trial processes not directly related to patients; and 29% for patient retention. Over the past two years, digital adoption has risen in all of these areas; to note that the use of patient retention tools is still steadily increasing while recruitment and adherence tools have now plateaued. Adoption of internal clinical ops tools—which increased by a staggering 21% in the last quarter at the expense of patient-facing tools—has now receded (36%).
[i] Source: Kezia Parkins and Andrew Hillman, “2022 forecast: decentralised trials to reach new heights with 28% jump”, Clinical Trials Arena, December 14, 2021 (https://www.clinicaltrialsarena.com/analysis/2022-forecast-decentralised-trials-to-reach-new-heights-with-28-jump).
Figure 1: The number of new clinical trials being initiated is no longer increasing
Figure 2: Most clinical trial sites still need more than a year to recruit patients
Figure 3: The percentage of clinical trial sites using digital tools is plateauing
THE USE OF KEY PATIENT-FACING TECHNOLOGIES IS RISING
Patient-facing technologies for clinical trials are on the rise. The $1.6 billion global market for electronic patient-reported outcomes (ePRO), e-patient diaries, and electronic clinical outcome assessments (eCOA) is projected to grow at a compound annual rate of over 14% to reach $2.8 billion by 2026.[i] More than ever, ePRO is integrated into electronic data capture (EDC) systems, allowing patients to log in and enter data into the diary or answer questionnaires directly. This is a major shift from only allowing investigators or study nurses to enter patient data into electronic case report forms (eCRFs)—a system in which site staff is usually using data that patients or caregivers write down on paper, causing inaccuracies, raising security and privacy issues, and increasing processing times.
Despite its outstanding potential, clinical trial sites still find it challenging to implement patient-facing digital technology, primarily due to logistical, financial, regulatory, and technical complexity. In our last DT tracker survey, research sites mentioned the ability of patients to use these technologies as a main concern limiting adoption; data showed a major shift in digital adoption from patient-facing tools to platforms used only for internal operations. Our Q3 2022 tracking data shows that, in the past six months, clinical trial sites:
- Have adopted more key 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 EDC systems/eCRFs, ePRO sites, and clinical trial management systems (CTMSes). This is the first time that ePRO appeared as one of the most used technologies, increasing from 37% to 46% in only six months. The data shows a sharp increase also for general eSource technologies (20%), eConsent (38%), and patient education tools (18%). Similar upward trend was observed for patient communication channels and patient relationship management portals. The adoption of content authoring platforms and real-world data and evidence (RWD/RWE) tools for patient retention remained very low.
- Don’t use the most effective technologies enough. When we asked how effectively digital technologies support clinical trial processes, three platforms exceeded expectations: virtual consultation channels, eSource, and tools for managing official queries (see Figure 5). However, this attitude is not reflected in adoption levels (see Figure 6). Key patient-facing technologies such as recruitment channels, ePRO, and remote monitoring tools are still not meeting expectations—a state of affairs that has held steady for recruitment sites over the past two years.
- Don’t use RWD/RWE tools for recruitment and report conflicting outcomes with retention. Very few clinical sites use RWD/RWE resources to support and speed up recruiting processes. Usage percentages, which were already very low in previous iterations (3%), have fallen to 1%. Sites’ primary digital recruitment channels are websites, social media, and email—at levels similar to the previous trackers (see Figure 7). Usage of RWD/RWE tools for purposes such as patient retention is also very low (5%). Interestingly, clinical sites hold conflicting views of how well RWD/RWE tools help with patient retention: 30% of respondents said it was significantly above expectations, while 20% said it was significantly below expectations.
- Remain concerned about cost, complexity, and patients’ ability to use technology. As in the previous tracker, the top three challenges related to deploying digital tools are finding the right digital tools, the ability of patients to use digital tools, and the cost of these tools (see Figure 8). The percentage of respondents saying that the lack of regulatory clarity was an obstacle to adopting new technology significantly decreased, although 10% of respondents report lack of support from regulatory teams and 5% from sponsors.
[i] Source: “ePRO, E-Patient Diaries and eCOA – Global Market Trajectory & Analytics”, Research and Markets, July 2022 (https://www.researchandmarkets.com/reports/5139503/epro-e-patient-diaries-and-ecoa-global-market).
Figure 4: Clinical trial sites are integrating more ePROs, eSource, and eConsent tools into their operations
Figure 5: Sites rate virtual consultation channels as the most effective technology to improve clinical trials
Figure 6: Sites are still not adopting the best-rated technologies at scale, and usage does not reflect value
Figure 7: Few clinical trial sites use real-world data or evidence databases for participant recruitmen
Figure 8: Concern about patients’ ability to use digital tools is still a top challenge to digital technology adoption
CLINICAL OPS MUST DEFINE DIGITAL BEST PRACTICES AND RETHINK RECRUITMENT
DT’s fourth Clinical Trial Digital Tracker found that the upward trend in digital technology adoption has stalled. While the adoption of key patient-facing technologies such as ePRO, eSource, and eConsent is still increasing, they don’t always deliver the promised value. To address key challenges and make further progress in digital maturity to enable great experiences for trial participants and clinical sites, pharma firms should:
- Define best practices for new patient-facing digital tools. Clinical research sites, sponsors, and participants are frequently scattered across the globe, posing major communication and regulatory obstacles. To hurdle these, clinical trial organizations require agile solutions that enable connections and safe, reliable, real-time data-sharing. eSource—data recorded in an electronic format at the source—has the most promise to transform how clinical trial stakeholders connect, delivering data directly from patients, investigators, and clinicians. ePRO and eConsent enable patients to input data themselves via wearables and mobile apps. For the first time, ePRO is the patient-facing technology most widely adopted by clinical sites globally. To maximize the value the technology adds, it’s important to define best practices for its use. For example, to assure data integrity and reliability, it’s key to define the cases in which researchers should execute a patient data change request directly, such as when it’s clear that information is being misinterpreted. Collaboration between sponsors and sites and integrating patients’ opinions can contribute to defining excellence.
- Facilitate the use of real-world data at clinical sites to improve recruiting and retention. Improving diversity and inclusion in clinical trials is top of mind for and the goal of most, if not all, pharma research clinical ops teams. While this can be facilitated by increasing the variety of clinical trial sites and helping less experienced sites conduct research, enabling individual sites to use RWD can also improve patient reach, enable synthetic arms, and support retention by making patient health history more visible. While clinical sites rely on their own patient databases for recruitment, they’re usually able to involve less than half of the suitable participants.[i] Enabling sites to access and use the larger databases included in RWD resources could narrow this gap and provide more reliable data to inform inclusion and exclusion criteria. RWD can also go a long way toward keeping patients in the trials.
- Improve communication channels with clinical trial sites. Sponsors should provide adequate training to investigators and site staff on how to better communicate trial opportunities in terms of patient benefit. Pharma firms need to help patients be aware of the expert care and attention they can expect during a clinical trial and to support sites so that they can deliver this. Communication channels need to be enabled across the globe, taking different languages and regulations into account. Assessing the experience and needs of clinical research staff at a given site is an important step to take before setting any new strategy to improve the relationship with that site.
[i] Source: Sharon Karlsberg and Cathy Zeanah, “Strategies to Close the Gap in Clinical Trial Recruitment”, Applied Clinical Trials, February 15, 2022 (https://www.appliedclinicaltrialsonline.com/view/strategies-to-close-the-gap-in-clinical-trial-recruitment).
The DT Clinical Trial Digital Tracker Survey, Q3 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 October 1, 2021 and March 31, 2022 and were actively recruiting participants. We recontacted sites included in the previous survey—2,933 global studies launched between October 1, 2020 and September 20, 2021—and received a total of 450 responses, 45 of which came from previous respondents.
DT Consulting contacted principal investigators via email in June 2022 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