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.
As the research community races to identify safe and effective COVID-19 therapies, researchers are in need of accelerating trial design without sacrificing quality. The Clinical Trials Transformation Initiative (CTTI) will discuss designing high-quality COVID-19 treatment trials via a webinar Thursday, April 23 at 9:30 ET.
Speakers will include:
Amid the COVID-19 pandemic, the value of master protocol studies has become clear: we need agile clinical trials that foster collaboration to address major public health threats and ongoing research challenges. CTTI invites members from across the clinical trials ecosystem to provide feedback on its draft resources to help drive the appropriate use of master protocols in diverse therapeutic areas.
Master protocols studies have the potential to more efficiently ask and answer...
During March 23-27, CTTI collected experiences from stakeholders across the clinical trials ecosystem – including insights on safety considerations, remote study visits, remote consent, consulting with IRBs, and more – related to the FDA’s new guidance on the conduct of clinical trials of medical products during the current COVID-19 pandemic. A recording of the March 31 webinar discussing those findings and best practices is now available .
Pam Tenaerts, CTTI, and M. Khair...
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: