At the forefront of transforming clinical studies is the Clinical Trials Transformation Initiative (CTTI), which has been instrumental in shaping the future of clinical trials to be more efficient, inclusive and patient-centered.
Under the recent leadership of Sally Okun, the past Executive Director of CTTI, the organization has embarked on an ambitious journey to reimagine how clinical trials are conceived and conducted, aligning with their visionary Transforming Trials 2030 initiative. According to the initiative, the five pillars to be achieved by 2030 are that clinical trials should be:
- Easily accessible and centered around the patient
- Fully integrated into health processes
- Designed with a focus on quality
- Maximally leveraging available clinical and nonclinical data, including data collected via digital technologies, to minimize the need for trial-specific data collection
- Contributing knowledge for the prevention, diagnosis and treatment of diseases, with clinical trials serving as one of many information sources that can be used to improve population health
Past Executive Director of CTTI
Our discussion with Okun sheds light on the significant milestones and strategic innovations CTTI has achieved recently. These efforts are not only enhancing the framework and methodology of clinical trials but are also setting the stage for profound impacts on global health outcomes. From pioneering new measurement standards to integrating cutting-edge digital technologies, CTTI’s work is a light for the future of clinical research.
Here, we explore several key developments that occurred under Okun’s recent guidance and look ahead to what the future holds for this influential initiative.
This interview with Okun was conducted in 2023 when Okun was the current Executive Director of CTTI.
XTALKS CLINICAL EDGE: Issue 2 — CTTI’s Interview
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Innovations and Accomplishments: The 2030 Measurement Initiative
Among the noteworthy advancements spearheaded by CTTI, the 2030 Measurement Initiative stands out in their strategic vision for transforming clinical trials by 2030. Launched in early 2022, this initiative was developed in response to a crucial observation by Okun upon her arrival at CTTI. She noted that while the vision for transforming clinical trials was robust, there was a significant gap in monitoring and evaluating progress towards these goals.
Sally elaborated on the initiative’s purpose: “We previously hadn’t identified ways where we would monitor or evaluate how well we’re doing in getting closer to achieving the vision. So this initiative really focused on how we could identify essentially the essence of each of the five pillars, and then figure out whether or not that could be measured, so that we could begin to evaluate and monitor progress over time.”
To address this, the 2030 Measurement Initiative was designed to establish a framework for continuous assessment across the five strategic pillars of CTTI’s transformation agenda. The initiative has successfully identified approximately 60 different metrics, spanning a range from near-term achievable goals to more aspirational long-term targets. These metrics serve as benchmarks for assessing the effectiveness and impact of various strategies and interventions implemented under each pillar.
The significance of this initiative cannot be understated as it not only provides a systematic approach to gauge progress but also introduces methodological rigor into the process of transforming clinical trials.
This strategic measure is vital for CTTI’s long-term vision, ensuring that all efforts are aligned with clear, quantifiable outcomes. It facilitates transparency and accountability, enabling stakeholders to see the tangible benefits of their contributions towards reshaping the clinical trials landscape. This initiative not only marks a significant achievement for CTTI but also sets a precedent for how trial transformations can be guided and measured systematically in the future.
Enhancing Diversity in Clinical Trials
A critical focus for CTTI has been to enhance diversity and inclusion within clinical trials, recognizing that diverse participation is essential for the generalizability and effectiveness of medical research. Under Okun’s leadership, CTTI has taken proactive steps to address these challenges through strategic initiatives and research that illuminate the path forward for more inclusive trials.
Okun discussed a recent project dedicated to investigating and implementing organizational-level practices that enhance diversity in clinical trials. This initiative specifically targeted increasing racial and ethnic diversity and the inclusion of women in clinical studies. Okun pointed out, “We focused primarily on diversity for racial and ethnic diversity and women. These were the areas we chose because they represent significant gaps in trial participation.”
The insights gained from this research were substantial. They revealed that incorporating diverse groups into clinical trials isn’t just a matter of ethical research practice but also a strategic imperative that leads to better science and more effective treatments. “The biggest piece that came from this,” Sally explained, “was a real commitment to recognizing the return on investments at the organizational level for adding these really essential practices and critical factors leads to a return on investment that brings you better science overall.”
CTTI’s Diversity Project Team has used these findings to craft and implement a series of best practices aimed at actively enhancing diversity within clinical trials. These practices include investing in staff training, allocating adequate resources and building the infrastructure necessary for advancing these diversity practices at the clinical trial level.
Furthermore, Sally highlighted the creation of a Diversity Maturity Model as a tool for organizations to assess their readiness and progress in implementing diversity practices effectively. “The maturity model is a nice place to begin when you’re starting to think about something that you want to incorporate,” she stated. This tool allows organizations to evaluate their current practices, identify gaps and plan for necessary improvements to foster a more inclusive environment.
By systematically addressing these critical factors and augmenting them with tools like the Diversity Maturity Model, CTTI aims to reduce barriers to participation and enhance trust within underrepresented communities. This approach not only improves the diversity of clinical trial participants but also ensures that the treatments developed are effective across a broader spectrum of the population, ultimately leading to better healthcare outcomes for all.
Digital Health Trials Hub: Embracing Technology
CTTI has keenly embraced the potential of digital technology to revolutionize clinical trials, a vision that took a significant step forward with the launch of the new online Digital Health Trials Hub in 2022. This initiative represents a pivotal evolution in integrating cutting-edge technologies within clinical research frameworks, substantially influenced by the accelerated digital transformation during the COVID-19 pandemic.
Okun discussed the importance of the hub, noting its role in updating and refreshing existing resources to align with current technological advancements. “Our work in digital health technologies began probably around 2018, and we were initially focusing on mobile technologies. But the field has advanced so much that a comprehensive update was necessary. The 2022 refresh was all about adapting to how far the field has come as a result of the pandemic and the use of some of these tools in ways we hadn’t envisioned before.”
The Digital Health Trials Hub now serves as a crucial resource for clinical trial professionals, offering guidelines, case studies and tools that demonstrate how digital tools can be effectively utilized in clinical trials. The hub facilitates a better understanding of digital health’s role and potential, encouraging more robust, scalable and patient-friendly trial designs that leverage digital tools for data collection, patient monitoring and treatment administration.
“The hub isn’t just a repository of information; it’s a dynamic platform where users can find case studies and examples of how organizations have implemented our digital health technology tools,” Sally mentioned. She highlighted the practical impact of this initiative: “There are four great examples in our case study exchange of organizations that have implemented some of CTTI’s digital health technology tools from that library of work. This is the place where we engage with those who have used the tools and can see a return on and an impact of how they were used.”
The Digital Health Trials Hub also aims to inspire ongoing innovation and adaptation in clinical trials. By providing access to the latest recommendations and success stories, it encourages trial sponsors and other stakeholders to consider how digital technologies can be integrated into their protocols, not just for efficiency but also to enhance participant engagement and data integrity.
Exploring Novel Clinical Trial Designs
Okun provided insight into how recent challenges posed by the COVID-19 pandemic catalyzed rapid advancements. “Novel clinical trial designs are actually an interesting outcome, frankly, of the pandemic. We were talking about some of the new ways that clinical trial design could evolve prior to the pandemic, but they got incredibly accelerated when we had to quickly decentralize trials from what had traditionally been a site at an academic medical center.”
The shift toward decentralized trials represents a significant departure from traditional models, where participants often had to travel to specific sites to receive treatment or monitoring. The necessity of adapting to pandemic constraints meant developing methods to bring trials directly to patients, enhancing accessibility and convenience. This has involved leveraging telehealth platforms, home-based monitoring technologies and local healthcare providers to administer treatments and collect data.
Okun discussed how these adaptations are not just temporary fixes but are shaping the future of clinical trials. “The idea of having decentralized trials where you meet the patient where they are versus expecting the patient to come to you, which sometimes might have been a huge burden, having to travel two or three hours to get to a study site, for example, now we’re looking more and more at how do we bring trials to the patient using some of the digital health technologies that we have today for remote monitoring.”
Furthermore, CTTI’s examination of novel trial designs extends beyond logistics to include aspects of trial structure and participant engagement. Innovations such as real-time data collection and analysis, adaptive trial designs that evolve based on interim results and patient-centric approaches that prioritize participants’ convenience and experience are all part of this new frontier.
These innovative designs are being supported by CTTI through guidelines and tools that help integrate novel strategies into practical, executable trial protocols. The initiative continues to work on overcoming regulatory and legislative hurdles, particularly those related to the delivery of investigational drugs and remote data collection, to ensure that these novel designs are not only scientifically sound but also compliant with current laws and regulations.
Future Directions: Focused Implementation and Convergence
As CTTI looks toward the future, their strategic focus is sharply centered on the practical implementation and broader convergence of their transformative initiatives. Under Okun’s past leadership, the emphasis has shifted from merely creating innovative strategies and recommendations to ensuring these are effectively adopted and have a tangible impact on clinical trials globally.
Okun stressed the importance of this transition, noting, “We’ve spent a lot of time looking at a few key areas. One of them is on understanding and exploring what CTTI’s role is in actually facilitating the implementation of the evidence-based practices that we’ve put out there in our recommendations.” This marks a significant shift in CTTI’s operational focus, aiming not just at innovation but at active facilitation and support to ensure that new methods and practices are adopted and integrated across the clinical trials landscape.
A primary area of focus is CTTI’s concept of “quality by design,” which is integral to the entire clinical trials experience. By prioritizing this area, CTTI aims to ensure that quality considerations are embedded from the earliest stages of trial design, thus enhancing the integrity and reliability of trial outcomes. Sally elaborated, “Quality by design is intentional because it crosses over the entire clinical trials experience. We want to figure out what CTTI’s role in driving implementation of those so that we can have things to actually monitor and measure over time.”
Another critical area is the integration of trials into clinical practice. This approach seeks to make clinical trials a more seamless part of healthcare, improving patient access and engagement while leveraging the infrastructure and resources of existing healthcare systems.
Collaboration with regulatory bodies such as the FDA is also on the agenda, particularly in harnessing the regulatory flexibilities that emerged during the COVID-19 pandemic. These flexibilities have shown potential for accelerating improvements in clinical trials and will be critical as CTTI and its partners work to implement these changes sustainably.
Lastly, CTTI plans to leverage existing resources like the Access to Aggregate Content of ClinicalTrials.gov (AACT) database more effectively. This database, which aggregates data from clinicaltrials.gov, provides a wealth of information that can be used to analyze and understand what factors contribute to successful clinical trials.
Sally highlighted the potential of using advanced data analysis techniques, including machine learning, to optimize the use of the AACT database, “We believe that there are lessons to be learned from having hundreds of thousands of study protocols to look at, to say, which protocols actually turned out to be a successful trial, which ones didn’t. Can we start to better understand why just based on really doing a better look at some of that data more systematically and methodologically.”
These future directions reflect CTTI’s commitment not only to fostering innovation but also to ensuring that these innovations are effectively implemented and lead to real changes in the clinical trials landscape, ultimately improving health outcomes globally.
Under Sally Okun’s past leadership, CTTI has not only envisioned a transformative future for clinical trials but has also laid down concrete steps to achieve this vision. With its robust strategies and collaborative efforts, CTTI is set to continue playing a crucial role in enhancing the design, execution and oversight of clinical trials, ensuring that they are more inclusive, efficient and aligned with contemporary technological and societal shifts.
The path forward is clear, and the potential for impact is immense, promising a new era of clinical research that is more responsive to the needs of a diverse global population.
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