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.
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The urgent need to rapidly identify safe and effective medical therapies has led to a spike in clinical studies on COVID-19. To help the global scientific community address this need, CTTI has created a searchable spreadsheet of COVID-19-related studies posted on ClinicalTrials.gov. The AACT COVID-19 Trials Spreadsheet is updated daily and was created from a search strategy developed by ClinicalTrials.gov and data from the Aggregate Analysis of ClinicalTrials.gov (AACT) database .
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The COVID-19 pandemic has caused many ongoing trials to switch to remote and virtual visits midstream, despite it being unchartered territory for many. On Clinical Trials Day, Wed., May 20, join the Clinical Trials Transformation Initiative (CTTI) for a webinar at 10 a.m. ET, to hear how stakeholders across the clinical trials ecosystem are adapting, overcoming challenges, and discovering new best standards for conducting clinical research via remote and virtual visits.
CTTI...
The International Council for Harmonisation (ICH) is revising ICH E6 Good Clinical Practice (GCP) and requests stakeholder feedback to inform the process. The U.S. Food and Drug Administration, in collaboration with CTTI, will help connect the issues by organizing a free two-day public web conference for discussion of ICH E6 on Thursday, June 4, and Friday, June 5, from 10:00 a.m. - 1:00 p.m. EDT.
It’s no secret that the entire clinical trials ecosystem is affected by painfully slow study start-up timelines. CTTI recently sought to investigate the factors that influence this crucial problem. After conducting a literature scan, in-depth conversations with sites and sponsor groups, and a working group meeting, CTTI released a report showing that budgets and contracts are significant contributors to delays.
During exploratory conversations, CTTI repeatedly heard from...
Now, more than ever, there is urgency to adopt telehealth for clinical research. But where do we begin?
Exchanging ideas is the first step. As a valuable member of the clinical trials community, we need your help – please tell us how your clinical trials are evolving to use telehealth (this can be using phone, Skype, or FaceTime for remote visits and/or using other telemedicine approaches) in light of the COVID-19 pandemic. What have you tried? What works well? What is...