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.