Digital Technology Adoption at Clinical Sites: Fast-Paced but Room to Grow

Digital Technology Adoption at Clinical Sites: Fast-Paced but Room to Grow

Francesca Properzi
DT Consulting

Sudip Sinha
Indegene
@indegeneinsight

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n September 2021, DT Consulting, an Indegene company, launched the 2^nd DT Digital Tracker, a methodology to assess the current state of digital technology adoption by clinical trial sites globally. The inaugural survey, which was published in February 2021 (see April 2021 Global Forum), showed that many clinical trial sites were still reluctant to integrate digital technologies into their processes and that cost, complexity, and finding the right technologies were the main barriers to digital adoption. The second wave of results shows that digital adoption is increasing and that concerns about patients’ ability to use digital tools is now the main barrier to digital adoption.

2021: Positive Year for Clinical Trial Research

As the industry continues to forge growth paths amid the ongoing pandemic, the global pharmaceutical and biotechnology sectors have been working on complying with regulatory requirements related 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 18 months.

Clinical research, medical technology (med-tech), and diagnostics continue to gain momentum. The previous report analyzed the number of clinical trials initiated each quarter starting in Q4 2019 and found a steady increase in clinical research. The latest analysis of the clinical trial database indicates that this momentum continues to increase. A significantly larger number of industry-funded clinical studies launched in the first half of 2021 compared with a year earlier (Figure 1). The number of studies that launched in Q2 2021 was 42% higher than in Q2 2020. A similar trend was seen for publicly funded studies: the number was 32% higher.

As faster FDA approval processes have also increased the drug approval rate, the focus on digital technologies adoption is now more important than ever to increase the chances of trial success, better data management, and more efficient drug development overall.

Emerging Trends in Clinical Trial Site Operations

At the end of 2020, all global interventional studies that launched from October 2019 through September 2020 were assessed. The survey found that 43% of clinical trial sites still avoided digital adoption for various reasons. In the second wave of respondents, including studies that launched from October 2020 through March 2021, digital tool use increased by 10% (Figure 1). More specifically, 67% of respondents said that they use digital tools to support clinical trials. Similar to the first wave of respondents who used 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. Twenty-six percent use digital tools to support clinical trial processes not directly related to patients.

The percentage of actively recruiting clinical trials using digital tools to support patient-related activities has increased from 2020 to 2021

Figure 1. The percentage of actively recruiting clinical trials using digital tools to support patient-related activities has increased from 2020 to 2021.

The second survey also revealed new trends around the most prominent challenges to the adoption of digital technologies. The top challenge is not knowing if patients are able to use digital tools. Clinical trial sites most often (36%) indicated that concerns about the ability of patients to use digital technologies were a challenge to digital adoption (Figure 2). 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. It is interesting to note that when respondents in the first wave were asked 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.

After March 2020, there was also 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.

Figure 2. Concern about patients’ ability to use digital tools emerged as the top challenge to digital technology adoption in the 2021 survey. (click image to enlarge)

Conundrum of Digital Patient Recruiting and Unexploited Potential of RWE Approaches

The second digital tracker survey results show that almost half of the studies initiated before October 2020 are still in the recruiting phase. 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 been successfully completed. Only 5% of studies were interrupted and 1% discontinued. This distribution across different trial stages could be within expectation depending on the phase and type of the study, therapeutic area, and geographic location. Nevertheless, the digital recruiting channels are still far from reaching their full potential in improving the efficiency of trials.

Figure 3. Effectiveness of digital tools in improving clinical trial process.

Figure 4. Use of real-world data or evidence for participant recruitment is still limited.

Although digital recruitment channels are the second most used technology (65% of users), only 53% of respondents using these tools said that they were very or extremely likely to support the trial process. In contrast, almost 90% of respondents using electronic data capture or an electronic case report form (EDC/eCRF), the most used technology, rated it as very or extremely likely to enable successful trial completion (Figure 3). The primary digital recruitment channels that respondents use are social media (26%), their own websites (21%), and email (16%). It is surprising that only 3% said they use real-world data/evidence (RWD/RWE) resources for recruiting (Figure 4). RWD not only optimizes patient recruitment via the identification of appropriate patients, but it can also be used to inform sample size calculations. Research has shown that clinical trial simulations based on RCTs and RWE could reduce the sample size of phase 3 studies by 40%, significantly reducing time and costs for sponsors and sites.

Overall, results show that the most used technologies are not necessarily the most effective. Sponsor support via clinical operations teams is critical to address challenges related to technology adoption, especially in assessing which new technologies could be more beneficial and facilitate data capture and flow. Our third DT Tracker Survey, which will be published February 2022, will specifically address sponsors-to-clinical sites interaction challenges.

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