Clinical Trials Supplement Celebrates One Decade of CTTI Impact
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.