September 13, 2021
The DT Clinical Trial Digital Tracker, Q3 2021
By Francesca Properzi with Carlos Capella and Tim van Tongeren
The State of Digital Adoption by Clinical Trial Sites
The COVID-19 pandemic posed significant challenges to clinical research. Clinical operations teams and clinical sites faced severe restrictions on travel and in-person interactions worldwide. As a result, in 2020 many trials were interrupted, delayed, or unable to launch and the enrollment of trial participants slowed sharply. To ensure the continuity of their research, many clinical trial teams adapted their operating model to decentralized, digital approaches such as providing home delivery of investigational study drugs, using online platforms for recruitment and enrollment, and enabling remote monitoring and virtual consultations via telemedicine and other applications.1 Despite the substantial disruptions, we see that:
- Clinical research continues to gain momentum. Our previous report analyzed the number of clinical trials initiated each quarter starting in Q4 2019 and found a steady increase in clinical research. Our latest analysis of the clinical trial database indicates that the momentum continues to increase.2 A significantly larger number of industry-funded clinical studies launched in the first half of 2021 compared with a year earlier (see Figure 1). The number of studies that launched in Q2 2021 was 42% higher than in Q2 2020; the number of publicly funded studies was 32% higher. We saw a similar trend for publicly funded studies.
- More drugs are gaining approval. In 2020, the FDA approved a large number of late-stage drug candidates for patient use, including fifty-three new molecular entities; in the past decade, only 2018 saw more FDA drug approvals.3 The momentum is continuing, with 29 new approvals in the first half of 2021.4 In 2020, more than half (58%) of the new approvals involved orphan drugs; 28% were submitted by large pharma firms; and more than 92% were first-cycle approvals. This is an encouraging sign that the FDA approval process is getting faster, albeit more expensive.5
Results From The DT Clinical Trial Digital Tracker, Wave 2 (Q3 2021)
The pharma and biotech sectors have been resilient in their response to pandemic restrictions, aided by the implementation of virtual and digital tools. The number of jobs posted by clinical trial organizations related to virtual trials has increased fivefold in the past eighteen months.6 Is this unprecedented digital transformation here to stay? What should clinical organizations do to support the momentum? To keep the transition going, it’s key to assess the state of digital adoption by clinical trial sites and to understand the approach they’re taking and the challenges they face in improving participants’ experiences.
With this in mind, we developed the DT Clinical Trial Digital Tracker to monitor how many active research sites use digital technologies; what digital tools they’re adopting; which tools deliver the best results; and what challenges sponsors and investigators face in integrating digital into their traditional operating model. At the end of 2020, we surveyed all global interventional studies that launched from October 2019 through September 2020 and found that 43% of clinical trial sites still eluded digital adoption for various reasons. The second wave of our survey addresses clinical trials that launched from October 2020 through March 2021. To monitor progress over time, we also recontacted all clinical trial studies that initiated before that date, including our previous respondents, to understand what they would have done differently in terms of digital adoption to improve the success of their study. Results show that clinical trial sites:
- Use more digital tools in new trials. In our second wave of respondents, 67% use digital tools to support clinical trials—a sharp 10-percentage-point increase over the first wave (see Figure 2). Of the respondents that use digital tools, 65% said they use digital tools for patient recruitment, 38% for patient adherence, 23% for patient retention, and 25% for other types of patient support; 26% use digital tools to support clinical trial processes not directly related to patients.
- Most often use EDC systems, digital recruitment channels, and ePROs. When we asked sites using digital tools about the types of tools they’re using or plan to use in their trial, the top three were electronic data capture (EDC) systems and electronic case report forms (eCRF) (71%), recruitment channels (44%), and electronic patient-reported outcomes (ePROs) (40%) (see Figure 3). Adoption of content authoring platforms and real-world data or evidence (RWD/RWE) tools for patient retention was very low (1% each). The primary digital recruitment channels that respondents use are social media (26%), their own websites (21%), and email (16%) (see Figure 4). Just 3% said they use RWD/RWE resources for recruiting.
- Use digital recruiting tools but frequently don’t rate them highly. While digital recruitment channels are the second most used, only 53% of respondents said that they were very or extremely likely to support the trial process (see Figure 5 and Figure 6). In contrast, almost 90% of respondents using EDC/eCRF, the most used technology, rated it as very or extremely likely to enable successful trial completion. A few others did very well: respondents said that clinical trial management systems (80%), ePROs (80%), and clinical trial analytics solutions (77%) are very or extremely likely to have a positive impact on trials. Content authoring platforms were less likely to deliver good results (40%).
- Almost half of the studies initiated before October 2020 are still recruiting. Of the studies that launched before October 2020, 49% are still actively recruiting participants, 21% are progressing and have moved on from the recruiting phase, and 20% have completed successfully (see Figure 7). Only 5% of studies were interrupted and 1% discontinued. When we asked our first wave of respondents what they would have done differently in terms of adopting digital tools, many mentioned adopting more remote technologies to reduce the number of patient visits and protocols to support patient logistics.
Clinical Trial Sites’ Challenges are shifting to Patient Needs
While the use of digital technologies and decentralized approaches to supporting patients deliver many benefits, they also present new challenges that clinical trial sites need to evaluate and address. Globally, healthcare systems have struggled to improve their digital infrastructure to support big data accessibility, reliability, and safety, which also affects the functionality of local clinical sites. In a recent survey to assess the barriers to using digital technologies in clinical trials, the majority of respondents said that data accessibility and ensuring data authenticity, integrity, and confidentiality are critical and limiting issues.7
Our inaugural DT Clinical Trials Digital Tracker Survey showed that several digital adoption challenges rose in significance after the COVID-19 outbreak; after March 2020, there was a sharp increase in the percentage of respondents citing the complexity of technology setup (from 9% to 15%) and understanding how digital tools really work (from 3% to 8%) as challenges. The latest survey reveals some new trends; when we asked our respondents about the most prominent challenges to the adoption of digital technologies, we saw that:
- The top challenge is not knowing if patients are able to use digital tools. Clinical trial sites most often (36%) said that concerns about the ability of patients to use digital technologies were a challenge to digital adoption (see Figure 8). Some respondents stated that this is particularly true for vulnerable patients such as the elderly, those suffering from rare diseases, and those with severe impairments. While there is an unquestioned opportunity for digital technologies to improve internal clinical operations, a patient-centric approach should take the needs of different patients into account and flex around these requirements. Although clinical trial sites express a willingness to use digital technology to support patients, they often cite the difficulty of managing patient training and experience and accessing the right tech support as obstacles.
- Getting and paying for the right technologies are still often cited as challenges. More than one-quarter of respondents said that finding the right tools (27%) and getting funding for these tools (27%) are key barriers to digital adoption. Nearly that many (23%) say that the complexity of setting up new tech impedes process innovation. They frequently indicate that financial and change management support from sponsors is inadequate, making it too risky to initiate projects involving novel technologies. As noted above, some of the most used technologies are not rated well in terms of their ability to improve trial execution. The hurdle is in evaluating the ability of innovative tools to deliver the expected results and produce a good return on investment (ROI). Sponsors must better understand the impact that digital adoption may have on clinical trial sites; they should engage with sites to manage expectations and ensure that they understand the potential value of new tech.
- Lack of clarity on regulations remains a significant impediment to innovation. For 23% of clinical sites, lack of clarity on regulations is an issue when adopting digital tools. This is particularly important if the technology uses patient data, which needs to be protected yet remain accessible. Different countries take different approaches to patient data privacy and accessibility, and sites need to follow each government’s regulatory and licensing requirements. For clinical trials operating across borders, ensuring a homogenous approach in the use of digital tools is not straightforward. Sites must also comply with regulations concerning remote monitoring safety and reliability; virtual tools and technologies that support medication adherence; and all devices and experimental medicinal products sent to patient homes. They also need to train staff and patients to ensure that the approved protocol is followed, and new technology is used correctly and in a manner that complies with regulatory requirements.
Align Clinical Ops’ Digital Strategy to the Needs of Sites and Patients
The DT Clinical Trial Digital Tracker offers timely insights into the state of clinical trial sites’ digital adoption, challenges, and satisfaction. Monitoring clinical trial sites’ experience is a strategic priority for pharma and biotech firms at a time when the clinical research industry is moving to virtual and digital approaches to bring processes in line with new regulatory requirements and stay competitive. Sites can facilitate and accelerate operating models for trial design and execution and improve participant experiences, diversity, and inclusion with decentralized approaches. For sponsors, understanding and aligning with the needs of clinical trial sites and patients is a unique opportunity to tailor digital capabilities to pipelines that support the drug development value chain from end to end to achieve strategic goals faster. Pharma firms should (see Figure 9):
- Define a clinical data blueprint. Many trial sites are now adopting EDC, eCRF, ePRO, and clinical trial management systems at scale and promoting new data capture systems such as eSource. New data sources include eConsent, remote monitoring and adherence, and virtual consultation, adding to the complexity of data capture, storage, flow, and use. As this data contains precious insights that can be used to improve current and future trial design, conduct, regulatory submission, and patient experience, a robust data strategy and methods are needed. The growing number and diversity of external clinical data sources have contributed to significant delays in drug development—but just one-third of clinical trial sponsors have a data strategy in place.8 Define a strategy for data use by mapping data sources, collection, storage, accessibility, integration and use cases across ecosystems and stakeholders to properly leverage the potential of technologies to deliver a solid ROI.
- Understand the needs and challenges of different patient and participants. Almost one-third of clinical trial sites said that they limit digital adoption as it’s unclear if patients can use digital technologies. This is indeed an issue for vulnerable patients and those in trials investigating rare diseases. Pathologies and patient groups that fit the inclusion criteria for certain drugs may have different requirements and ability to use digital tools. The study design process should involve patients and investigators early on to discuss protocol development, technology adoption, and training needs to facilitate patient journeys. For rare-disease trials, technologies can enable a network of support with research nurses, doctors, and primary caregivers. This is essential when testing orphan drugs, where limited information on adverse and side effects is available and patient retention is critical to trial success.
- Build flexible capabilities leading to digital maturity excellence. The most-used technologies are not necessarily the most effective. This is particularly true for recruiting channels; despite being well-adopted, they still rate below average on effectiveness—and six months after our initial survey, almost half of sites are still recruiting. The right technology may not be sufficient to deliver results; it must be underpinned by robust skills, talent, and best practices. Defining KPIs is essential to be able to monitor progress. Agile operating models and teams can flex around activities and technologies and adjust to pipeline priority changes. A successful digital capability requires combining technology and people effectively.
- Measure clinical trial site digital adoption and satisfaction. Clinical trial sites are essentially customers of pharmaceutical companies. Research centers with expertise and access to specific patient groups can choose sponsors based on how much support they provide. It’s important that pharma firms understand which factors affect the experience of research staff when collaborating. More clinical trial sites are adopting technologies to support patients and streamline processes, worry about equipping patients with new technologies, and minimize in-person visits by adopting virtual/remote strategies. Sponsor support could be critical to addressing challenges of technology complexity and cost, especially in assessing which new technologies could be more beneficial and facilitate data capture and flow.
The DT Clinical Trial Digital Tracker Survey, Q3 2021 was an email-initiated online survey based on the database at www.clinicaltrials.gov. The survey covers 2,933 global industry-funded interventional studies that launched between October 1, 2020, and March 31, 2021 and were actively recruiting participants. We received a total of 151 responses. We also recontacted sites included in the previous survey—4,460 global studies launched between October 1, 2019, and September 30, 2020. From this group we received a total of 153 responses.
Tim van Tongeren