CTTI is pleased to announce the addition of two experienced patient advocates to its Executive Committee:

Donna Cryer is the CEO of the Global Liver Institute, which promotes innovation and fosters collaboration to improve the health of patients with liver disease.

Pat Furlong is the founder and CEO of Parent Project Muscular Dystrophy, which works to end Duchenne muscular dystrophy by accelerating research and advocating for optimal patient care.

“CTTI recognizes the importance of meaningful patient engagement in both our organizational structure and project work, and in the broader clinical trials enterprise,” said CTTI Executive Director Pamela Tenaerts. “We are excited for Donna and Pat to serve on our Executive Committee and ensure that the patient voice is represented in decisions regarding CTTI’s direction and strategy.”

As members of the Executive Committee, Cryer and Furlong will offer valuable perspectives in driving toward CTTI’s vision of a high-quality clinical trials system that is patient-centered and efficient. They bring decades of experience in patient and caregiver advocacy in the nonprofit sector. Both have served as advisers and consultants to government agencies, professional societies, and advocacy organizations.

“CTTI’s mission to increase the quality and efficiency of clinical trials is achievable when we have the broadest range of stakeholders at the table,” said CTTI Executive Committee Chair Mark McClellan. “Donna and Pat will strengthen our ability to promote patient and caregiver engagement across the clinical trials enterprise.”

The two new CTTI Executive Committee members join a distinguished group of thought leaders with the knowledge and experience to make meaningful improvements in clinical research.

    Donna Cryer                      Pat Furlong

Clinical Trials featured a supplement in its March 2018 issue (available online now) celebrating a decade of CTTI’s impact on clinical trials. The supplement includes articles on CTTI’s accomplishments and lessons learned over the last 10 years, its unique methodology, its work to promote patient engagement and clinical trial quality, and the role it can play in addressing ongoing and future challenges. All supplement articles are freely accessible.

Since its inception in 2007, CTTI has conducted more than 25 projects and issued recommendations for strategies to enhance the quality and efficiency of clinical trials. In an introductory article, John Alexander, Duke University; Jacqueline Corrigan-Curay, FDA; and Mark McClellan, Duke University, explore the defining features of CTTI that have allowed it to move the needle toward more efficient, high-quality clinical trials over the last 10 years. In subsequent articles:

• Pamela Tenaerts, CTTI; Leanne Madre, CTTI; and Martin Landray, University of Oxford, share common themes and lessons learned that have emerged during the course of CTTI’s work, including the importance of engaging many stakeholders, advance planning to address critical issues, and new opportunities presented by technology. Read this article.
• Amy Corneli, Zachary Hallinan, Gerrit Hamre, Brian Perry, Jennifer Goldsack, Sara Calvert, and Annemarie Forrest, all of CTTI, describe CTTI’s collaborative, five-step methodology: stating the problem and identifying impediments to research, gathering evidence to identify gaps and barriers, analyzing and interpreting findings, finalizing solutions by developing recommendations and resources, and driving adoption through dissemination and implementation. Read this article.
• Bray Patrick-Lake, Duke Clinical Research Institute, discusses CTTI’s pivotal role in promoting patient engagement in clinical trials through organizational practices, formal project work, and external advocacy efforts. Read this article.
• Ann Meeker-O’Connell, Johnson & Johnson, and Coleen Glessner, Alexion Pharmaceuticals, explore how CTTI led a transformational shift in moving clinical trial quality from an after-the-fact endeavor, focusing on monitoring and audits, to a core element of clinical trial design. Read this article.
• Hans-Georg Eichler and Fergus Sweeney, both with the European Medicines Agency, consider key challenges that the clinical trials community continues to face—including globalization, transparency, operational complexity, and expense—and describe the role CTTI can play in addressing those obstacles. Read this article.

In a symposium held Feb. 6, more than 150 attendees, including leaders from across the clinical trials enterprise, gathered to celebrate CTTI’s 10-year anniversary and discuss how CTTI’s work has led to improvements in clinical trials. Highlights from the day included a keynote address by Robert Califf, former FDA commissioner, and engaging panels with stakeholders from across the enterprise on topics including quality by design (QbD), patient engagement, use of a single IRB of record, and the future of clinical trials.

Clinical Trials Reflections & Predictions

In the keynote address, Califf noted that incremental changes to improve clinical trials, including those CTTI has prompted, make a difference—but there is still a lot of work to be done. He went on to describe major trends that are shaping the future of clinical research. Califf’s vision is that patients and healthcare systems will align to produce needed evidence to guide clinical care and medical product use. He also described the culture change required to make research data sharing more prevalent, and how CTTI could help to promote this change.

Improving the Quality & Efficiency of Clinical Trials

A vibrant discussion on QbD followed. Presenters from Amgen and Johnson & Johnson shared how their organizations have implemented CTTI’s QbD recommendations and the benefits observed. Panelists from the FDA and the University of Oxford reiterated the value of dedicating adequate time and attention to the planning phase of clinical trials, despite so many organizations being focused on reducing time to first patient in. QbD is not just about avoiding the inclusion of unnecessary elements in a trial, it is also really thinking about the totality of what you are trying to accomplish.

Engage Early. Engage Often.

The next panel was a powerful testament to the value patient engagement can bring to clinical trials. The patient group Friedreich’s Ataxia Research Alliance and Horizon Pharma shared details of their inspiring partnership and how CTTI’s recommendations have helped them work together effectively. Panelists from Tufts University and DCRI echoed the importance of patient engagement early and often in clinical trials. There is often a disconnect between organizations’ stated commitment to patient engagement and its implementation—CTTI is committed to addressing these barriers and has developed a framework for measuring the return on investment of patient engagement.

Use of a Single IRB for Multi-Center Trials

In discussing the shift to a single IRB of record, a case study from Norwell Health showed how using CTTI’s resources resulted in more trials using a single IRB and improved study startup times. Still, communication can be challenging between the reviewing IRB, human research protections office, and local site investigators. Panelists from OHRP, Celgene, and FDA weighed in on the benefits (e.g., consistency in informed consent documents) and remaining challenges (e.g., how to measure quality IRB review) associated with the single IRB model. Education and resources to aid the transition, including those developed by CTTI, were felt to be critical.

The Future of Clinical Trials

The symposium concluded with a lively panel on the future of clinical trials with thoughts from the FDA, patient groups, NIH, and others. Issues discussed included positive publication bias, data interoperability, economic factors, and the need for innovators to take charge in using platform trials and flexible designs. It was noted that real-world evidence will not solve everything, and some therapeutic areas are advancing more rapidly than others with improvements to clinical trials.

Many great ideas came out of the day to inform future CTTI work. CTTI encouraged those who have implemented CTTI recommendations to share their experiences so the examples can help inform the enterprise.

The presentation slides from the Symposium are now available online.

This year, CTTI marks its 10th year of working with a variety of stakeholders to positively change clinical trials, making them more streamlined, efficient, and patient-focused. To commemorate this milestone, we will #CelebrateCTTI throughout the month of January. Join us for the celebration—visit this blog, follow us on Twitter, and register to attend our 10 Year Anniversary Symposium on Tues., Feb. 6.

 

At CTTI, we don’t just generate ideas—we create change. To help implement improvements, we develop resources and hold workshops to facilitate the adoption of CTTI recommendations. Numerous organizations, institutions, and other entities have taken advantage of these resources and are realizing the benefits of more efficient and higher quality clinical trials. We are also prompting widespread improvements in clinical trials through influence at the policy level. Examples include:

As CTTI’s work continues to grow, so do the many examples of our impact—together, we are shaping the future of tomorrow’s better, safer clinical trials.

This year, CTTI marks its 10th year of working with a variety of stakeholders to positively change clinical trials, making them more streamlined, efficient, and patient-focused. To commemorate this milestone, we will #CelebrateCTTI throughout the month of January. Join us for the celebration—visit this blog, follow us on Twitter, and register to attend our 10 Year Anniversary Symposium on Tues., Feb. 6.

Since 2007, CTTI has completed more than 25 projects related to critical issues affecting clinical trials, including quality by design, recruitment, data monitoring, electronic healthcare data, informed consent, safety reporting, using use of a single IRB of record, and many more. This work has influenced or been cited by FDA, EMA, NIH, and other policymakers, and our resources are used every day by sponsors, investigators, research professionals, patient groups, and others to improve clinical trials.

 

From the beginning, the involvement of all stakeholders has been integral to CTTI’s work. Individuals from more than 430 organizations have been involved in CTTI project teams or meetings to date. This collaboration has allowed us to see diverse perspectives and create resources that can be used by the many different individuals and groups involved in designing, conducting, and evaluating clinical trials. We remain committed to collaborating with all stakeholders to create consensus-driven, actionable recommendations that are grounded in evidence.

 

We look forward to the next 10 years of working with our stakeholders to enhance the design and conduct of clinical trials, thereby benefitting the entire clinical trials enterprise.

You are invited to join past and present CTTI leaders, and experts from across the clinical trials enterprise, for an exciting public symposium to help CTTI celebrate “One Decade of Impact. One Vision Ahead.” The event will take place on Tues., Feb. 6, from 8:30 a.m. – 4:00 p.m. at the DoubleTree by Hilton Hotel in Bethesda, Md.

 

The symposium will feature a lineup of distinguished guest speakers, case studies, and a vibrant exchange of ideas around the future of clinical trials. Presenters include leaders from all sectors involved in clinical trials, including government, industry, academia, and patient groups.

 

Attendees will learn how CTTI has influenced the clinical trials enterprise during the past decade, hear from a number of stakeholders about the benefits of applying CTTI recommendations, and learn how CTTI’s current work will shape clinical trials in the future. The sessions will focus on implementation and impact in areas such as quality by design, patient engagement, and the use of a single IRB of record.

 

View the full agenda and RSVP online today.

 

Please contact Kimberley Smith if you have questions.

 

Confirmed Speakers

 

Driving insights to action with our latest findings

At this year’s DIA Annual Meeting, CTTI will present new approaches that can help bring the use of mobile technology in clinical trials from promise to reality. Advancements in data capture with mobile technology can translate to improved clinical trial quality and efficiency. CTTI will share case examples and methods for addressing specific challenges of integrating mobile devices into clinical trials in four presentations. These are preliminary results from CTTI’s Mobile Clinical Trials Program.

In addition, we will share our latest findings on measuring the financial impact of patient engagement from the Patient Groups & Clinical Trials Project. If you’ve been searching for a way to help sponsors and patient groups speak the same language in terms of perceived value of collaboration, this is the presentation for you. It is widely accepted that patient engagement can add value to the research process, but when it comes to business decisions, sponsors may be reluctant to allocate resources to patient engagement without a measure of financial impact. We present financial modeling for the impact of patient engagement to help inform these decisions.

DIA 2017 will be held in Chicago from June 18-22 and is themed “Driving Insights to Action.” Please join us for CTTI’s presentations:

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Presentation: At the cornerstone of wearable technology and patient-focused clinical trial endpoints (#227)
Date & Time: Tuesday, June 20, 2017 from 10:30-11:45 a.m.
Presenters: Leonard Sacks, Nikunj Patel, Robert DiCicco, Ray Dorsey
Related CTTI Projects: MCT Novel Endpoints & Mobile Devices

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Presentation: Generating novel endpoints through mobile technology: A promising and realistic new approach to trial design (#244)
Date & Time: Tuesday, June 20, 2017 from 2:00-3:15 p.m.
Presenter: Robert DiCicco
Related CTTI Project: MCT Novel Endpoints

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Presentation: Getting down to the nitty-gritty: Addressing the specific challenges of electronic data and mobile devices in clinical trials (#308)
Date & Time: Wednesday, June 21, 2017 from 10:30-11:30 a.m.
Moderator: Jonathan Helfgott; Presenter: Jennifer Goldsack
Related CTTI Project: MCT Mobile Devices

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Presentation: Getting down to the bottom line: Measuring the financial impact of patient engagement (#316)
Date & Time: Wednesday June 21, 2017 from 10:30-11:45 a.m.
Presenter: Bennett Levitan
Related CTTI Project: Patient Groups & Clinical Trials

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Presentation: Straight from the horse’s mouth: Lessons learned from legal & regulatory challenges of real remote trials (#366)
Date & Time: Wednesday, June 21, 2017 from 4:00-5:15 p.m.
Presenter: Gerrit Hamre
Related CTTI Project: MCT Legal & Regulatory

An editorial appearing in the May 12th edition of Media Planet, a supplement of USA Today, describes the unique methods that CTTI pioneered, and continues to rely on, to transform clinical research.

In Improving Clinical Trials Through Thoughtful Collaboration, Annemarie Forrest, CTTI’s Associate Director of Projects, makes the case that all voices must be included in the conversation if we are going to transform the U.S. clinical trials system. Key to CTTI’s ongoing efforts is the combination of data-driven approaches with the active engagement of all stakeholders, including healthcare providers, regulators, academia, industry, and patients and their families. By fostering dialogue and learning among people who represent a diverse array of backgrounds, knowledge, and experience, CTTI works to enable novel insights about how to accelerate the development of new therapies for the patients and families who need them most.

The tools and recommendations that grow out of CTTI programs and initiatives offer workable, evidence-based solutions. From companies adopting CTTI recommendations to improve the design and conduct of clinical trials to major patient advocacy groups using our tools to streamline trials through their interactions with trial sponsors, CTTI is helping to lead the way toward a better, more efficient clinical trials enterprise.

Find out more about CTTI’s projects and programs here.