Themes from the eClinical Solutions’ 2023 Industry Outlook

Clinical data acquisition, infrastructure, and analytics are amid a period of rapid change. Keeping abreast of this fast-paced trajectory by understanding how the wider industry is responding to opportunities and bottlenecks is key to maintaining a strategic competitive edge.

With that in mind, as part of a 2023 Industry Outlook report, eClinical Solutions surveyed 60 clinical operations, data management and biometrics professionals to gain insights on their experiences of clinical data trends and challenges within their organizations and what they see as the greatest opportunities ahead for digital transformation. In this blog we share three of the themes that feature most prominently for leaders in their day-to-day work lives today, based on their responses to a series of questions about clinical trends, challenges, and opportunities.

Realizing immediate efficiencies takes priority

It was clear that companies are continuing to grapple with the implications of a growing variety and volume of external data sources with 64% of respondents saying that they are using over 6 external sources routinely within their trials. In fact, a significant minority of 29% of respondents were using over 10 external data sources –presenting both an opportunity and a challenge. At the same time, organizations remain focused on accelerating cycle times with 69% of respondents seeking a time from database lock to LPLV (Last Patient, Last Visit) of 4 weeks or less, with 37% aspiring to a time from database lock to final TLFs of 2 weeks or less.

Against this backdrop of productivity pressure coupled with growing complexity, we asked respondents for their views on the greatest industry priority for the coming year. They selected their top trend from an array of promising opportunities included decentralized clinical trials, artificial intelligence, evolving roles and responsibilities, patient-centricity, RBQM (Risk-Based Quality Management), and automation.

Automation led the pack as the hottest priority for 36% of respondents, indicating that the need to realize efficiencies in speed and quality may be more immediately pressing than strategic shifts such as risk-informed approaches and decentralized trials – at least for now.

Certainly, at eClinical we have seen first-hand that by automating repetitive tasks across database builds, technical documentation, and operational reporting, we can achieve efficiency gains of between 50% and 90%. Such improvements when replicated across the trial lifecycle stand to generate a significant uplift in productivity and quality.

Quality and speed remain pain points in EDC (Electronic Data Capture)

Despite advances in technology, sponsors are still experiencing unmet needs in achieving their desired outcomes for EDC builds. 30% of respondents cited speed as a top challenge while 30% cited quality as the most prominent pain point in study start-up. Adaptability was also on our respondents’ minds with respect to data acquisition, with just under 60% of respondents noting that 3-5 protocol amendments would lead to database updates. Notwithstanding the trend towards decentralized and hybrid trials, EDC is likely to remain a cornerstone of data collection within clinical development so resolving these pain points is critical. Certainly, there are opportunities for sponsors to unify their technology stack with service providers who have the expertise to use platforms to their best advantage.

People are key to unlocking technology value

Technology is advancing at pace and the industry is realizing the promise of tools such as clinical data platforms, advanced statistical computing, automation, and machine learning to make better, faster decisions. Nevertheless, the survey results reflect the truth that people unlock the value of technology and securing successful outcomes. Putting in place the right people, with the right skills to do a given task, and who can spot opportunities for technology and process transformation is essential. However, achieving this can be challenging in a talent-scarce environment. Indeed, in considering their relationships with service providers, our respondents cited interlinked pain points of sufficient expertise, turnover and innovation. The need to access data-specific know-how and boost innovation are key drivers of the growing trend towards specialized outsourcing models such as biometrics-focused FSPs (Functional Service Provider) which allow sponsors to access hard-to-hire talent, assure standardization and build efficiencies for data management, biostatistics and statistical programming functions across trial programs.

For more insights on how your peers are responding to current clinical data trends, challenges, and opportunities from decentralization to automation, access your complimentary copy of the Industry Outlook 2023 report below.

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The influence and importance of the clinical biometrics discipline is set to expand in the light of an increasingly data-centric clinical trials landscape. Complex clinical trial designs and a growing volume and variety of data require advanced analytics and flexible data management approaches. At the same time, a pressing need for real-time access to data requires shifts in the technology, skills, and processes applied from data acquisition to insight, while patient-centricity and decentralization are also ushering in new ways of designing, managing and analyzing trials.