Who We Are

CTTI MISSION: To develop and drive adoption of practices that will increase the quality and efficiency of clinical trials

CTTI One-Pager


At its most fundamental level, the Clinical Trials Transformation Initiative (CTTI) is a group of individuals and organizations who want to improve the quality and efficiency of clinical trials. It was co-founded by Duke University and the U.S. Food and Drug Administration in 2007 in an effort to identify and address challenges to well-designed, properly executed clinical trials, and offer recommendations to improve and modernize research.


CTTI fosters an open forum for all stakeholders - 500+ organizations and approximately 80 member organizations - to discuss issues, exchange ideas, come to consensus, and create solutions that can be used to drive real and positive change in clinical trials.


"Our unique approach blends diverse viewpoints to challenge the status quo and create solutions to critical clinical trials issues,” said Pamela Tenaerts, executive director of CTTI. “We are re-shaping policies and procedures across the ecosystem, helping to efficiently generate high-quality evidence faster and, ultimately, improve the health of people."


CTTI’s vision – Transforming Trials 2030 – is that, by 2030, clinical trials:

  • Are patient-centered and easily accessible.
  • Are fully integrated into health processes.
  • Are designed with a quality approach.
  • Maximally leverage available clinical and nonclinical data, including data collected via digital technologies, to minimize collection of necessary trial specific data.
  • Contribute knowledge about how to prevent, diagnose, and treat disease, and clinical trials are one of many sources of information that can be acted upon to improve population health.

To achieve this, we work on the most important and forward-looking issues in clinical research - those that will move us toward high quality, efficient trials as quickly as possible. Our projects focus on clinical trials involving medical procedures and FDA-regulated medical products, with an emphasis on regulatory submission clinical trials because of their unique issues and critical importance.


While we may focus on clinical trials from a US perspective, as a global citizen, we recognize that clinical trials are global. We will consider other geographies and collaborate with organizations in those geographies as opportunities arise.



  • Act in the interest of the public’s health to improve clinical trials
  • Make publicly available recommendations and resources to improve clinical trials
  • Hold paramount the need to protect trial participants
  • Ensure quality of clinical trial data is appropriate for decision-making needs
  • Value the input and participation of all stakeholders equally
  • Identify and manage conflict of interest and bias
  • Ensure integrity and transparency of CTTI activities


Hear from Rob Califf, MD, MACC, on CTTI Strategy:

*Video date: October 25, 2012