The Clinical Trials Transformation Initiative (CTTI) is conducting information from clinical sponsors and sites based the recent events triggered by the COVID-19 pandemic. The FDA recently issued new guidance on the conduct of clinical trials of medical products during these trying times. CTTI, a leading contributor to research and knowledge in the world of clinical trials, seeks sponsors and sites to share their experiences and insights, in the context of the new guidance. What have you tried related to issues such as safety monitoring, remote data capture, etc.? What works well? What have you thought of doing but have not yet tried?
See the link to share your experience: here.
The CTTI will collect all experiences and input by tomorrow, Thursday March 26 at noon ET, aggregate everyone’s feedback, and summarize best practices and insights. They will publish this information via a Webinar (password: ctti) on Tuesday, March 31 at 11:15 a.m ET.
By exchanging best practices and insights, we can continue our important work to develop needed medical products during this situation, and perhaps even glean some opportunities to do clinical trials better once this public health crisis has passed.
About Clinical Trials Transformation Initiative
The Clinical Trials Transformation Initiative (CTTI), a public-private partnership co-founded by Duke University and the U.S. Food and Drug Administration, seeks to develop and drive adoption of practices that will increase the quality and efficiency of clinical trials. Comprised of more than 80 member organizations—representing academia, clinical investigators, government and regulatory agencies, industry, institutional review boards, patient advocacy groups, and other groups—CTTI is transforming the clinical trials landscape by developing evidence-based solutions to clinical research challenges. Many regulatory agencies and organizations have applied CTTI’s more than 20 existing recommendations, and associated resources, to make better clinical trials a reality. Learn more about CTTI projects, recommendations, and resources here.Source: Qualtrics