The clinical trials industry is buckling under the weight of continuously growing complexities. Developing an interconnected clinical trials ecosystem will be essential to minimizing the ripple effects of complexity impacting your sites and patients.
As sponsors and CROs move towards adaptive trial designs, develop targeted therapies, and embrace the decentralized trial model, some increase in operational complexity is to be expected.
But this means leaders need to be ready with a response that can help preserve trial timelines and data accuracy without overburdening sites and patients.
How can technology help teams navigate trial complexity instead of crumbling under it?
Growing Complexities Expose a Flawed Systems
‘Complexities’ feels like a broad term, but there are many elements that introduce complexity to your trials.
- Growing Protocols and Procedures: According to a Tufts CSDD study, distinct protocols in phase 2 and 3 trials have risen 44% since 2009 and currently involve 263 procedures per patient, on average.1
- Drowning in Data Points: The average number of trial endpoints has been rising 6% every year since 2003, with the average protocol generating 20 endpoints.2 In fact, phase 3 protocols collect three times more data than the last decade, resulting in cumbersome data lakes.2
- Exclusionary Eligibility Criteria: Eligibility criteria have continued to expand, especially for rare disease or novel trials, with an average of 31 eligibility criteria in phase 1, 2, and 3 trials.2
- Expanding Network: An average phase 1 protocol between 2013 – 2019 was found to be conducted across seven investigation sites based in two distinct countries.3 Phase 2 and 3 protocols were conducted at 34 and 87 sites across six and 14 countries, respectively. And the number of investigation sites has increased by 33% since 2009.3
- Increasing Focus on Precision Medicine: Precision medicine, especially oncology, has become a much larger industry focus. These treatments often require patients with specific biomarkers using targeted therapies and a greater collection of genetic information throughout a study.5
When asked to weigh in on the cause of these rising complexities, professor and director of Tufts CSDD, Ken Getz, said, “What we’re seeing is the consequence of biopharmaceutical companies engaging in more ambitious and customized drug development activity that targets a growing number of rare diseases, stratifies participant subgroups using biomarker and genetic data, and relies on more structured and unstructured patient data from a larger number of sources.”3
As clinical trials become more ambitious, they naturally need to expand into new systems or protocols. But this growing complexity, when not properly managed, can have devastating consequences to your clinical research.
As Getz went on to say, “Our data shows very strongly that the complexity of the design has an inverse relationship to performance and to speed. The more complex the protocol, the slower our speed, and that’s really reflected [in clinical trial timelines].”4
These changes to performance and speed have ripple effects throughout your trial:
- As the number of unique data sources and endpoints increase, sponsors are struggling to ingest, aggregate, and standardize data across dispersed systems.
- The sheer volume of data collected is leaving sponsors with data lakes they are either ill-equipped or ill-prepared to analyze and store.
- Without a centralized hub or data dashboard, teams lack the visibility they need to assess risks, conduct issue resolution, or make data-driven decisions.
- Sites are burdened by the pressure to meet aggressive study timelines while managing very manual, complex processes.
- As eligibility criteria and demands on the patient increase, it becomes harder to find and retain study volunteers.
On top of this, the industry has faced a rise in internal reviews, with the average phase 3 oncology trial conducting 9.7 reviews. As Getz noted in a XTalks webinar,4 “We’ve seen in other Tufts Center studies that the larger the number of internal reviews, the greater the complexity, the longer it takes to actually conduct the study.”
Why Eliminating Complexities Isn’t Enough
To combat the challenges listed above, many clinicians have asked, “Why don’t we see more protocol simplification?”
Attempts have been made to simplify or remove complexities from clinical trial protocols. But the explosive growth in data collection and management is the result of innovation and reflects a changing clinical trial paradigm. Eliminating complex protocols is not always realistic or feasible. Instead, experts like Ken Getz and other industry leaders suggest learning to manage trial complexities, rather than eliminate them.
To mitigate complexities, some organizations have begun grading protocols based on their patient burden index.4 Others are turning to authoring tools or investing in site and patient feedback. To improve the relevance of protocols, some companies are finding success with cross-functional internal review committees.4
In tandem with these efforts, teams are reevaluating their eClinical suite to maximize their trial efficiencies. Fortunately, the introduction of new data points and workflows doesn’t always require new technology. Clinical Trial Management Software (CTMS) has evolved to keep up with the changes of modern trials and is emerging as a forefront technology in simplifying the complexities of managing clinical trials.
We will explore how unifying your management functions through a powerful CTMS can accelerate drug development in a single platform and help you manage complexities in your trials.
How CTMS Navigates Trial Complexities
If we think of clinical trials as an ecosystem, CTMS can be considered the “brain” of the operations.
The average trial relies on a host of employees, sites, and systems. Thanks to hybrid technology reducing or eliminating the need for traditional in-person workflows, clinical trials now support an even wider array of stakeholders and sites. But as our ecosystems grow, it can become harder to manage study operations and maintain oversight of site team performance, subject visits, and payment status, among other day-to-day activities.
CTMS simplifies your trial management by providing unified oversight of study activities across your trial portfolio. Consolidating your workflows reduces information fragmentation and allows teams to operate on the same up-to-date study data. Instead of teams relying on outdated spreadsheets (and making decisions based off of that data), having access to the same data at the same time unlocks synchronicity across your teams and informed decision making. In addition, the cost and complexity of managing trials using disparate systems is reduced with the implementation of a secure hub for global surveillance and collaboration.
This hub unlocks access to constantly updated, trusted study data in a centralized dashboard without complex manual, human-driven processes.
Instead of study teams taking on the burden of data entry, reconciliation, and management, workflows are automated and the output is centralized in a dashboard that visually displays study data and makes it more intuitive.
With a system that automatically tracks data from multiple sources, teams experience the productivity and efficiency benefits of a “one-stop-shop” for insights into trial planning, operations, and execution, and reduce the risk of missing out on important information about study milestones, issues, and performance.
When teams have a centralized system for clinical trial management, it unlocks further benefits that reduce complexities in your trials:
- Study Standardization: Protocols can be centralized and set up in a structured manner, then implemented across dispersed teams for consistent, clear processes.
- Project Management: Easily plan, track and manage key trial activities and data across functional areas and geographic regions. Dashboards and visualizations allow users to work at a portfolio or study level, or drill down to manage the day-to-day.
- Cross-Team Collaboration: Having a single source for trusted study data empowers teams to collaborate easily without toggling between platforms or waiting on reconciliation.
- Simplified Site Management: As the number of unique sites grows, CTMS allows teams to manage everything from site selection, initiation, contracting, payments, and visit monitoring.
- Integrated Issue Management: Issues and action items are centralized, tracked, and reported on in real-time so teams can collaboratively identify root issues and prioritize a proactive response.
- Regulatory Readiness: Remain “regulation ready” by storing regulatory documents alongside tracking data and metadata on one single, integrated and pre-validated system.
- Patient Recruitment and Enrollment: Track recruitment and enrollment efforts against predetermined milestones to identify potential delays or step in to aid recruitment efforts for specific sites or countries.
- Intuitive Interface: Engaging your teams on a single intuitive interface creates a more efficient user experience that drives engagement and reduces the need for specialized staff or third-party support.
Expanding CTMS Visibility with EDC
The benefits of CTMS and unified trial management cannot be overstated, especially when it comes to trial complexity. But to truly unlock a unified system, your CTMS should natively sync with your electronic data capture (EDC).
When your EDC data automatically reflects in your CTSM, it can create a single source of truth for your entire trial. Going back to the earlier analogy: if your CTMS is the “brain” of the operations, then your EDC is the “heart.”
And when these two systems connect seamlessly, you can achieve a full picture of your clinical trial ecosystem with a few clicks of a button.
Instead of managing or toggling between systems, integrating them creates a powerful solution to reduce redundancies in trial management and maximize workflow efficiencies. For example, when your participant consent, randomization, and trial supply data captured by your EDC is auto-populated into your CTMS, teams can access timely information on patient and study progress and mitigate issues as they arise.
This constant flow of information equips teams with the knowledge they need to manage costs, meet timelines, and protect study outcomes without wasting valuable time managing complexities.
Cut Down on Trial Complexities with CTMS + EDC
Managing trial complexities will continue to challenge the clinical research industry. Instead of fighting the tides of change, teams should focus on equipping themselves with tools that cut down on manual efforts and reduce complexities through unified trial management.
When your CTMS and EDC systems natively integrate, redundant efforts are reduced and teams are given faster, more accurate data. Instead of wasting precious time on disparate systems or complex workflows, the right CTMS + EDC integration gives teams time back to focus on what really matters: achieving life-saving breakthroughs.