May 3, 2018 – The report highlights the organization’s efforts to improve the quality and efficiency of clinical trials.
The Clinical Trials Transformation Initiative (CTTI) has issued its 2017 Annual Report, celebrating a decade of CTTI impact and highlighting its activities and accomplishments over the past year. The report includes reflections from past and present CTTI leaders, case studies on the use of CTTI recommendations and resources, and a glimpse into what lies ahead for CTTI and the clinical trials enterprise.
CTTI, cofounded by Duke University and the U.S. Food and Drug Administration and hosted by Duke, develops recommendations, tools and resources to enable a high-quality, efficient clinical trial system. The organization studies current clinical trials processes, identifies impediments to beneficial change, and develops consensus-driven, evidence-based recommendations and solutions to improve clinical trials.
Since its founding in 2007, CTTI has completed more than 25 projects with the aim of increasing the quality and efficiency of clinical trials. The resulting recommendations were downloaded more than 26,000 times over the past year.
CTTI issued five new sets of recommendations in 2017, many of which draw on recent advances in technology and data sciences to bring about improvements for clinical trials. The report includes CTTI’s latest recommendations and resources, which offer:
- Practical guidance for using mobile technology to develop viable novel endpoints for clinical trials.
- Best practices for assessing and designing registries for use in clinical trials so that the data can meet expectations for FDA review of new products.
- Actions that can be taken to strengthen the investigator site community and create an environment that sustains long-term investigator engagement.
- Guidance on planning for and making decisions about pregnancy testing in potential trial participants.
- Suggested ways to address the unique challenges of conducting pediatric antibacterial trials.
As described in the report, these recommendations and resources are being implemented by organizations across the clinical trial spectrum, including IQVIA, monARC Bionetworks, and the Pulmonary Fibrosis Foundation.