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.
Apply Filter View All
The FDA and CTTI are currently accepting applications from patient advocates interested in becoming members of the Patient Engagement Collaborative (PEC) . The PEC is an ongoing, collaborative forum that brings the patient community and regulators together to discuss ways to increase patient engagement in medical product development and regulatory discussions at the FDA.
Applicants will be selected based on their ability...
Organizations are gaining experience using CTTI’s Quality by Design (QbD) recommendations to design and conduct better clinical trials. CTTI today announced four new QbD case studies , adding to its robust QbD toolkit. Three of the case studies are also now featured in CTTI’s recently-announced Building Better Clinical Trials: A Case Study Exchange resource.
The case studies provide an in-depth look at real-word implementation of QbD...
Timely and complete registration and results reporting of clinical trial information is an important part of keeping patients, providers, researchers, and the public informed about clinical trials. The Food and Drug Administration Amendments Act of 2007 (FDAAA) requires that the responsible party for an applicable clinical trial register and submit results information for the trial to the ClinicalTrials.gov databank to promote transparency and accountability, in an effort to limit duplicity and encourage others to build on results. Despite...
COVID-19 forced the clinical trials ecosystem to plan and conduct research in remote or virtual settings. In an effort to support this shift, CTTI is launching a project to update its Decentralized Clinical Trials (DCT) recommendations to ensure they reflect the latest learnings and emerging best practices from the pandemic.
CTTI’s current DCT recommendations, which launched in 2018 and focus on the use of...
Recordings for the International Council for Harmonisation’s public web conference, held May 18 & 19, “ICH E6 Guideline for Good Clinical Practice (GCP) – Update on Progress,” are now available .
The web conference, which consisted of identical meetings at different times over two days to accommodate a global audience...