CTTI was founded over 15 years ago in the fall of 2007, holding our first Executive Committee meeting on March 4, 2008. Since then, CTTI has continued to work towards our mission of developing and driving the adoption of practices that increase the quality and efficiency of clinical trials. CTTI’s progress toward our bold Transforming Trials 2030 vision is due to the invaluable effort, support, and collaboration of our founders, members, staff, and stakeholders. As we celebrate our 15th anniversary, we would like to thank the more than 700 organizations and nearly 3,000 individuals whose work and commitment have helped us to advance and transform the clinical trials enterprise. We look forward to your continued support as we work together to shape the future of clinical trials.

By: Sally Okun, CTTI Executive Director

Take a moment and think back to 2007. In that year Apple released its first iPhone, which has since sold more than 1.5 billion units worldwide. NASA launched the Phoenix Mars Lander, which entered the Martian atmosphere within nine months and shortly thereafter confirmed that the soil it ‘tasted’ contained water ice. And An Inconvenient Truth won the Oscar for best documentary and brought the topic of climate change to the forefront of mainstream culture. 

And in 2007, the Clinical Trials Transformation Initiative was founded with the ambitious mission to improve the quality and efficiency of clinical trials and by the spring of 2008 held its first meeting of the Executive Committee. Since then, CTTI has had an influential role in advancing incremental change in clinical trials by working collaboratively with stakeholders from across the clinical trials enterprise, including industry, academia, patients and patient advocacy groups, biotechnology, professional societies, and government agencies. Together with its member organizations, this public-private partnership of the U.S. Food and Drug Administration and Duke University has completed 50 projects, publicly launched 105 recommendations and tools, and published 88 peer-reviewed articles. And then in 2020, CTTI set its sight on the future with its bold vision for Transforming Trials by 2030. 

Now with CTTI’s 15th anniversary upon us, I sat down with three members of CTTI’s leadership team whose tenures with the organization range from 12 years to less than two and asked them to reflect on CTTI’s enduring impact, share their insights on CTTI projects they are most proud of and think about their aspirations for CTTI in the coming five years:  

• Sara Calvert, Director of Projects, has been with CTTI for 12 years and holds much of the organization’s institutional memory. Sara reflected on the first project she took on as a project manager at CTTI – to address challenges of adopting single Institutional Review Board (sIRB) review. Listening to Sara describe the evolution of this work was fascinating. It began in 2010 as the Central IRB Project and in 2013 shifted to Central IRB Advancement. By 2017 the work, reflecting a change in nomenclature, focused on Single IRB Adoption and eventually in 2018 it evolved to Single IRB Evaluation. Sara is pleased that the work of these completed projects continues to guide investigators and others newly introduced to the use of sIRBs in their research. And she noted the that this important body of work was recently cited in the U.S. Government Accounting Office Report to congressional requesters titled IRBs: Actions Needed to Improve Federal Oversight and Examine Effectiveness. 

• Zach Hallinan, Director of Strategic Engagement and Communications, spoke with pride about his role as the project manager for CTTI’s Quality by Design (QbD) portfolio to which he was assigned upon joining the organization nearly 7 years ago. As he spoke, a pattern emblematic of CTTI projects emerged – they address complex issues; they take time; and they may pivot or expand their scope in response to new insights, changing regulatory requirements, legislative mandates or shifts in practice across the clinical trials enterprise. In this case, what started as a project on improving monitoring procedures in 2010 changed as the project team recognized monitoring is just one component of an overall quality approach that is needed for trial planning, conduct, and oversight. By 2018 CTTI’s QbD Adoption project was underway with the objective of creating tools and resources to support implementation of the critical to quality elements for improving clinical trial quality and efficiency. Before long, the University of California Irvine used CTTI’s resources to develop their Critical to Quality Design Studios and shared this work in CTTI’s Case Study Exchange. Additionally, Zach noted that CTTI members recently ranked the QbD portfolio as the highest priority for dissemination across the clinical trials enterprise. 

• Morgan Hanger, Director of Strategic Programs, joined CTTI less than two years ago and quickly recognized CTTI’s potential to be a catalyst for enduring and transformational change. Morgan’s interest in driving implementation toward lasting impact has positioned CTTI more intentionally to convene our colleagues from across the clinical trials enterprise to explicitly align our goals and activities in certain key areas. While we are still in the early stages of this convergence work, Morgan believes this orientation will be transformative for driving outcomes and shared accountability across all the organizations and related efforts working to improve trials. Morgan also proudly shared the progress made on the first activity she took on when joining CTTI in January 2022 – to advance the development of metrics for monitoring and evaluating progress on the five pillars of CTTI’s Transforming Trials 2030 vision. A project team and expert panel are currently being convened to take the results of the evidence gathering work to the project’s next phase. 

Universally, Sara, Zach and Morgan cited CTTI’s role in ensuring that patients and patient advocates always have an equal voice on CTTI project teams and at expert meetings. They all expressed pride that CTTI was at the forefront of engaging with patients and patient advocates as true partners from the organization’s earliest days and that legacy continues today. 

The impact of CTTI’s work will be not measured in units sold or in discoveries on a distant planet, but rather in bringing to the forefront of mainstream awareness translatable knowledge and actionable evidence generated through clinical trials that are:  

• truly person-centric and easily accessible by all who want to participate in them;  
• transparently integrated into the healthcare received by all;
• always designed with quality and representativeness at their core;
• maximally leveraging all available data while never compromising on individual privacy, autonomy, and choice.

As members of CTTI’s leadership team, we wish to acknowledge and collectively celebrate the thousands of individuals, organizations and team members who are foundational to CTTI’s work and without whom the accomplishments of the last 15 years could not have been achieved. When the time to celebrate our 20th anniversary arrives, we trust that — together with the clinical trials enterprise — we will be well on our way towards the transformative change we envision for 2030. 

The report of the public webinar on “ICH M11: Clinical electronic Structured Harmonised Protocol (CeSHarP),” organized by the International Council for Harmonisation (ICH) and convened by the Clinical Trials Transformation Initiative (CTTI), is now available. More than 1,700 people registered for the webinar, which was held on January 26, 2023. 

The ICH M11 Expert Working Group (EWG) members, who are updating the guideline, explained the benefits and opportunities that will be created for stakeholders with the electronic exchange capabilities of an internationally harmonised structured protocol template. The EWG members presented an overview of the M11 Guideline and the associated protocol template and technical specification. In closing, EWG members answered common questions that were submitted by participants during the registration process. 

View the recording and slide deck of the webinar to learn more. 

For additional information on the ICH M11 Guideline, please see the ICH Guidelines site, M11 Draft Guideline, M11 Template, and M11 Technical Specification.