Strategic Plan

Version: May 2016 


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


A high quality clinical trial system that is patient-centered and efficient, enabling reliable and timely access to evidence-based therapeutic prevention and treatment options


  • Major Clinical Trials. CTTI projects focus on regulatory submission clinical trials because of their unique issues and critical importance. Our scope consists of interventional clinical trials including but not limited to, pragmatic clinical trials, cluster randomized trials, clinical trials with historical control arms, delayed start designs, adaptive designs (e.g. Bayesian methods, master protocols), and trials leveraging existing data sources.
  • Global Partner with a U.S. Perspective. 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 the clinical trial enterprise
  • Hold paramount the need to protect trial participants
  • Ensure clinical trials data is of highest quality for decision-making
  • Value the input and participation of all stakeholders equally
  • Identify and manage conflicts of interest and bias
  • Ensure integrity and transparency of CTTI activities


Improvements in the clinical trials enterprise happen through transformative and incremental change. CTTI efforts focus on making change in the following areas:

  • Systematic approach to evidence generation, including use of non-traditional clinical trial data sources and technical innovations
  • Patients as equal partners across the research and development continuum
  • Clinical trials that are designed with a focus on efficiency and quality
  • Trials that address emerging public health concerns
  • Safe and ethical trials that are streamlined


  • Create recommendations and tools every year to improve clinical trials
  • Make publicly available the data upon which recommendations are based
  • Communicate our work broadly to inform all stakeholders
  • Demonstrate impact of CTTI’s work
  • Characterize clinical trial landscape so that trends can be tracked over time