Who We Are

The Clinical Trials Transformation Initiative (CTTI) is a public-private partnership to develop and drive adoption of practices that will increase the quality and efficiency of clinical trials.

CTTI now comprises more than 80 organizations from across the clinical trial enterprise. Members include representatives of government agencies (the FDA, Centers for Medicare and Medicaid Services, Office of Human Research Protections, National Institutes of Health, and other national and international governmental bodies), industry representatives (pharmaceutical, biotech, device, and clinical research organizations), patient advocacy groups, professional societies, investigator groups, academic institutions, and other interested parties.

Download the "About CTTI" one-pager

Patients and those who care for them want access to new drugs, devices, and biological products as quickly as possible, while also being assured that the benefits of these products outweigh the risks. While well-designed randomized clinical trials are the most reliable way to get unbiased information to achieve this, our current system of conducting clinical trials is often paper-based, slow, and costly. Poor quality and inefficiency in clinical research can seriously limit the number of questions that we can answer about the appropriate uses of approved or licensed medical products and significantly delay access to new therapeutic innovations.

Increasingly clinical trials are being conducted outside of the United States (US). The reasons behind this shift need to be understood so that US patients can continue to be represented in international clinical trials. Reasonable numbers of US patients being included in trials is critically important to address the appropriate use of products by US citizens.

In light of these issues and concerns, CTTI was established by the US Food and Drug Administration and Duke University in 2007. CTTI’s approach includes conducting projects to better understand the range of current practices, assess alternative approaches, understand barriers to change, and propose recommendations for improvement. Members contribute ideas for projects, participate in their conduct and analysis, and are committed to disseminating CTTI recommendations and encouraging adoption of system changes that will improve the efficiency of clinical trials. Funding from member organizations provides support for projects and infrastructure, according to a fee schedule published on the CTTI website. The Executive Committee oversees the use of these funds.

 

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

*Video date: October 25, 2012