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.
Designing clinical trials during a pandemic presents significant challenges. However, it is possible to build trials that yield high-quality results without slowing down the process.
In a webinar from Thurs., April 23, titled “Designing High-Quality COVID-19 Treatment Trials,” a diverse group of stakeholders presented perspectives that can inform COVID-19 researchers on best practices for designing and quickly launching trials that improve quality and minimize burdens on front-...
The COVID-19 pandemic has turned our world upside down. Every aspect of our ways of life are experiencing unprecedented disruptions.
For the clinical trials community, we are seeing steep declines in patient enrollment and, in some cases, complete pauses of trials. A report from Medidata showed an 83 percent decrease in new patients entering trials in China in February 2020 compared to February 2019 and similar trends have been seen in other countries. In the first half of March this year, the U.S. has had a 62 percent decrease in new patients entering trials.
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...