Clinical Data Trends, Challenges, and Opportunities

Clinical Data Trends, Challenges, and Opportunities

Based on results of 2022 survey with clinical data professionals

About the Author – Katrina Rice

Katrina Rice is an accomplished Chief Delivery Officer with an impressive leadership career that spans over 25 years. With a strong history of leading business transformations and managing global portfolios, she is as much at home scaling operations as she is in developing data strategies that enable growth for trial sponsors. At eClinical Solutions, Katrina leads our thriving data services group, delivering high-quality data management, biostatistics, and biostatistical programming

outsourcing solutions that enable pharmaceutical sponsors to maximize the value of their clinical data, through people, process, and technology. Katrina has previously held various technical roles at Lockheed Martin Energy Group and Bayer. She holds a Bachelor of Science degree in Computer Science from Alabama Agricultural and Mechanical University and a Master of Science degree in Computer Science with Advanced Applications from the University of New Haven.

Executive Summary

Leaders in clinical trials today are navigating a host of tough challenges and promising opportunities. As ever, clinical operations and data management professionals are challenged to increase efficiency and reduce cycle times, while grappling with greater trial complexity and talent scarcity. At the same time, decentralization, automation, and advanced analytics have the potential to transform—for the better—the way we execute and analyze clinical trials. At the heart of this change, is a heightened recognition of the importance of clinical data as the critical asset and developing data strategies that can evolve in line with the company’s goals.

KEY TAKEAWAYS:

of people, process and technology working seamlessly together. At eClinical Solutions we are passionate about empowering our clients with both transformative technology in the form of of the elluminate clinical data cloud and expert clinical data services —for end to end biometrics implementation—equipping sponsors of all sizes for an era of digital trials.

■ 64% of respondents are incorporating 6 or more external data sources

■ Harnessing automation is the top overarching industry priority

■ Speed and quality are both substantial painpoints for EDC database build

As an industry, it is imperative that we come together to overcome these challenges, and effectively harness all our available tools, to deliver the right therapies, to the right patients faster. Making good on this promise of advancement, will rely not on technology alone, but a combination

At our ENGAGE 2022 meeting for elluminate users, the eClinical Solutions team came together with clinical operations, data management, biostatistics, and clinical programming leaders from a range of sponsors and partners. We took the opportunity to survey participants 1 on the trends, pain points, and opportunities that were top of mind in their roles. In this report, we summarize the insights from the survey findings of almost 60 respondents and discuss the implications for outsourcing solutions and the industry as a whole.

Industry Priorities

We asked respondents what they saw as the top focus for the industry today. Overwhelmingly, automation was seen as the highest priority, surpassing other ‘hot’ areas such as DCT (Decentralized Clinical Trials), patient-centricity, and risk-based approaches. In our view, this reflects the pressure on biopharmaceutical companies to decrease cycle times—since harnessing automation and streamlining repeatable tasks offers immediate realizable value. The second highest overall priority was evolving roles and responsibilities, which chimes with our position at eClinical Solutions that having the right people with the right skills is more essential now than ever to unlock the full potential of the greater data assets and technologies that we now have at our disposal.

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Technology and analytics are essential for honing in on data anomalies, missing data, and erroneous data to enable timely course correction.”

What

Data Volume and Data Sources

In an era of data proliferation, ensuring that we are focusing on the data that is relevant to the study endpoints is paramount. It was encouraging that 36% of our respondents reported that at least half of their collected data was feeding directly into study endpoints. However, while we always expect a certain proportion of data collection for exploratory purposes, the results reveal that there is still room for improvement in focusing efforts on the critical data that answers the research question of interest. A close alignment between data management and statistics from the outset of the trial is important here, as is data management expertise in translating even complex protocols into an effective eCRF.

Similarly, the results confirmed previous research findings that sponsors are routinely using an increasing number of external data sources beyond EDC (Electronic Data Capture). This pre-existing trend has accelerated as the industry pivoted to decentralized and hybrid approaches during the pandemic. The top challenges experienced by our respondents in handling this external data were accommodating a growing variety of data types, and standardization. Reconciliation, vendor compliance, and data transfer agreements were also reported as pinch points. Grappling with these external data issues requires not only technology solutions, but service providers with the experience to work in a more data-diverse environment and used to leveraging a range of digital tools.

At eClinical, our data services team has developed a Center of Excellence for external data focused on addressing these core issues by streamlining processes for working with external vendors, standardizing external data, and maximizing the use of elluminate.

What percentage of data collected at your company feeds into study endpoints?

On average, how many external data sources (outside of DCT) are you incorporating at your company?

What is your top challenge with external data?

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Data Acquisition

Overwhelmingly, speed and quality in execution of database builds remain the biggest challenges for our sponsor respondents, while cost was least commonly cited as the most pressing concern. These results reflect the ongoing need for sponsors to focus on uniting effective technologies with people who can deliver against their full potential. In our experience, actions such as building in quality checkpoints throughout the study, enhancing the therapeutic and technical expertise of the team, and harnessing automation to streamline routine tasks, all positively influence speed and quality outcomes. Building a partnership with a database build provider can be beneficial in creating efficiencies over time.

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. In the context of greater complexity, sponsors must ensure that they have the right technologies and services solutions in place to handle evolving protocols. Beginning with the end in mind is critical for success here, and ‘future-proofing’ at database build stage by anticipating for changes down the track, simplifies necessary modifications, without compromising quality.

Against a backdrop of increasing trial complexity, as data services providers we need to be able to pivot quickly without impacting data collection objectives. At eClinical Solutions, our people understand the impact of making changes on systems and are equipped to handle those adaptations.”

Williamson, Director of Data Acquisition, eClinical Solutions

What is your biggest challenge with database build? On average, how many protocol amendments lead to database updates at your company?

Working with Service Providers

Overwhelmingly, expertise was cited as the biggest challenge of working with service providers, with staff turnover second. These perennial clinical trial outsourcing concerns reflect the reality that despite the evolution of technologies, ensuring the right people are assigned to any given job, and are equipped with the right skills, remains essential. It is especially critical to get right in skills-scarce areas such as clinical data management, biostatistics, and statistical programming, with fierce competition for the right talent.

Service providers and sponsors alike need to evolve training that is fit-for-purpose in the current environment. For data management and analytical professionals, training goes beyond the technical know-how required to do the job and extends into leveraging technology and therapeutic expertise. For example, at eClinical we have initiated a data management ‘boot camp’ for skills development, focusing on the areas of greatest evolution. Developing skills that allow team members to direct their own career paths also mitigates the risks of high staff turnover—which has a known impact on knowledge retention and study oversight for sponsors. A portfolio model, which assigns team members to specific clients, also supports retention by freeing up staff for relationship-building and greater strategic focus.

Conclusion

The themes which have emerged from this survey— automation, cycle time reduction, data acquisition, and equipping people with the right skillsets—are all areas we are actively addressing at eClinical Solutions.

For example, we have experienced first-hand, that through automating repetitive tasks across database builds, technical documentation, and operational reporting, we can achieve efficiency gains of between 50% and 90%. In turn, these approaches positively impact quality, and reduce the burden on team members, freeing them up for more strategic contributions.

Focusing on skills development that equips data professionals for the evolving nature of their roles, promotes quality, minimizes staff turnover, and enables our clients to benefit from efficient data services, while maximizing the value of their technology investment.

Though the survey results reflected a prioritization of immediate pain points of efficiency and expertise above strategic shifts such as risk-informed approaches, and decentralization, we understood from our direct conversations during the ENGAGE meeting, that these topics are moving into the foreground. Accessing the right expertise and technologies to execute decentralized trials and navigating the change management required for risk-informed approaches will be essential.

To succeed in our data-centric, changing drug development world sponsors and service providers alike should balance extracting maximum value from immediately available efficiency gains, with commitment to innovation fit for the future-state.

eClinical

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Methodology and approach:

This survey was created to gain illustrative insights and a ‘pulse check ‘of the most pressing concerns for our clients attending the ENGAGE meeting and to inform our data services and elluminate approach. We received responses from 57 professionals working across clinical operations, data management, statistical programming and biometrics functions.

Solutions’ Clinical Data Services team offers end-to-end biometrics implementation, from data acquisition to insight, accelerated by elluminate.

To arrange a discussion with Katrina Rice about how we can help maximize the value of your clinical data!

eclinicalsol.com info@eclinicalsol.com T: 877-355-8668 (877-ELLUMN8)

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