This is your one stop shop for updates on CTTI projects, developments in the clinical trials enterprise and other relevant news. To read the full-length entry, or to share a specific blog post, click on the title of the article of interest.
This week, stakeholders from across the clinical trials ecosystem submitted experiences and insights related to the FDA’s new guidance on the conduct of clinical trials of medical products during the current COVID-19 pandemic. The Clinical Trials Transformation Initiative (CTTI) collated the feedback – including insights safety considerations, remote study visits, remote consent, consulting with IRBs, and more – and will share the findings and best practices via a webinar on Tuesday, March 31 at 11:15 a.m. ET.
A recording is now available of a CTTI webinar on new stakeholder-informed research to identify areas within ICH E6 GCP that are in the greatest need of renovation. The webinar, held Thurs., March 19, included several perspectives about how this research could further the international conversation about ICH E6 GCP:
CTTI Will Collect, Share Findings & Best Practices at a March 31 Webinar
Last week, the FDA issued new guidance on the conduct of clinical trials of medical products during the current COVID-19 pandemic. While we never could have imagined conducting clinical trials in this situation, by working together and listening to each other’s experiences, we can identify best practices for continuing to conduct important clinical trials and ensuring the safety of...
A CTTI paper recently published in the Pediatric Infectious Disease Journal sheds light on risk factors that make children more likely to contract hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP).
These risk factors are important because they could aid in earlier and more accurate diagnosis of HABP/VABP, alleviating roadblocks to enrollment in HABP/VABP clinical trials. Improved enrollment could help speed the development of new antibiotics for HABP/VABP, which can often be deadly for children....
As the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) begins revisions to ICH E6 GCP, new CTTI research highlights opportunities for changes and improvements.
CTTI will host a webinar Thurs., March 19, at noon ET providing an overview of new multi-method research to identify areas within ICH E6 GCP that are in the greatest need of renovation. Speakers will include: