The Clinical Trials Transformation Initiative (CTTI) is a public-private partnership co-founded by Duke University and the US Food and Drug Administration (FDA).
Last week CTTI and industry professionals gathered to celebrate the initiative’s 10-year anniversary.
To learn more about some of the key projects completed and challenges faced over the last decade – and what to expect from the next 10 years – we caught up with CTTI Executive Director Pamela Tenaerts.
How has CTTI's work over the past decade helped to address some of the key challenges facing clinical trials?
CTTI has played a pivotal role in impacting and evolving clinical trials over the past 10 years. Most notably, we became a leader in improving clinical trials by informing the thinking of policymakers and being referenced by several governmental and regulatory bodies, and many other collaborators in the clinical trials enterprise.
We spearheaded upfront planning to improve protocol quality (aka Quality by Design (QbD)) as a viable way to prospectively incorporate quality into clinical trials. And lastly, CTTI led by example in engaging stakeholders from across the enterprise to identify solutions to some of the most immediate clinical trials challenges.
Together, we developed a robust set of evidence-based recommendations and resources that have informed the thinking of policymakers and enabled organizations to conduct more efficient and higher quality clinical trials.
Of the more than 25 projects CTTI has completed since it was established, what is one that stands out as having had the most significant impact?
All of our projects play an important role in changing clinical trials—many have influenced or been cited by the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), National Institutes of Health (NIH), and other policymakers, or guided sponsors, investigators, research professionals, patient groups, and others to improve clinical research. Collectively, our work is advancing clinical research across the entire enterprise.
In particular, CTTI’s QbD work, as mentioned earlier, stands out because it’s already had such a powerful impact on the enterprise. Using our QbD recommendations and tool kit, many organizations have been able to implement a novel approach: prospectively building quality into the scientific and operational design of clinical trials. By focusing on quality in clinical trials, namely the absence of errors that matter, sponsors can make their trials safer, more reliable, and more patient-centric.
How has CTTI’s recommendations evolved over the past ten years? How do you expect they will continue to advance?
From the beginning, our recommendations were rooted in multi-stakeholder input and evidence—that hasn’t changed.
One thing that did evolve was CTTI’s increased role in helping organizations “take action” with our recommendations by issuing resources, such as checklists, decision trees, and editable chats, to help guide implementation.
Today, we continue to adapt our existing and future recommendations to better meet the evolving needs of clinical trials decisions-makers and adopters, and even further drive impact.
Looking back over the past decade, what are the biggest changes from when CTTI was established to the present day?
The entire clinical research environment has greatly changed over the last decade. There are more organizations working on various aspects of trials, new challenges and obstacles to overcome, and—most importantly—ample opportunity to change the way clinical trials are designed and conducted.
CTTI is increasingly working with stakeholders across the enterprise to thoughtfully address ample opportunity to change the way clinical trials are designed and conducted these issues at the policy level and further pave the way for the next generation of clinical trials.
What can we expect to see over the next decade?
Transforming clinical trials is going to take continued dedication, collaboration and innovation, and CTTI is well positioned to help the enterprise move ahead.
Within CTTI, we are eager to advance some exciting work that’s already underway—in the areas of technology in clinical trials, evidence generation, and more—and continue to engage all stakeholders to question the status quo and bring about quality, efficient, and patient-focused clinical trials.
Without a doubt, our work over the past 10 years has set the foundation for better clinical trials we are excited to see the progress we make in the next decade.