Author: Hannah Faulkner

CTTI Updates DCT Recommendations in Response to COVID-19

Posted on by Hannah Faulkner

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 telemedicine, mobile and local healthcare providers, and related topics, were the most frequently downloaded document on CTTI’s website in 2020, reflecting the increased demand for decentralized solutions in times of COVID-19.

This new project aims to support the accelerating adoption of DCT solutions in clinical trials going forward. The updated recommendations will focus on selecting and operationalizing DCT solutions, ensuring effective safety monitoring, and appreciating the needs and perspectives of investigators, sites, and participants.

This effort builds on CTTI’s initial recognition that running a DCT does not have to be all or nothing. DCTs can be completely virtual, but many will be partially decentralized using a hybrid approach. Regardless of where a trial falls on the decentralized continuum, it is always important to:

  • Plan ahead as much as possible
  • Involve all stakeholders early and often
  • Focus on what matters
  • Communicate and be transparent

Sponsors and CROs can use the revised recommendations to design a fit-for-purpose, efficient DCT—one that can reduce patient burden, improve enrollment, and more closely replicate real-world populations and scenarios.

Recording of Public Web Conference Now Available: Listen to ICH E6 Guideline for Good Clinical Practice (GCP) – Update on Progress

Posted on by Hannah Faulkner

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, opened with welcoming remarks followed by a video session wherein ICH E6 Expert Working Group (EWG) members shared the ICH guideline development process and the approach to updating ICH E6(R3). The second session of the web conference focused on the vision and goals for the work to update the E6 guideline and lessons learned from public input and stakeholder feedback. In the final session of the web conference, members of the EWG presented the published draft, work-in-progress principles. Then, experts and advocates provided their vision and aspirations on the clinical trial enterprise in general.

View the full slide deck for day of the web conference to learn more from each presenter.

For additional information on updating the ICH E6, please refer to the following materials: