Share Your Experiences Related to the New FDA Guidance on COVID-19

CTTI Will Collect, Share Findings & Best Practices at a March 31 Webinar

Last week, the FDA issued new guidance on the conduct of clinical trials of medical products during the current COVID-19 pandemic. While we never could have imagined conducting clinical trials in this situation, by working together and listening to each other’s experiences, we can identify best practices for continuing to conduct important clinical trials and ensuring the safety of participants.

This is where you come in. We need everyone involved in clinical trials right now – IRB professionals, investigators, coordinators, monitors, sponsors, participants, and others – to share your experiences and insights, in context of the new FDA guidance, on issues such as safety monitoring, remote data capture, etc. What have you tried? What works well? What have you thought of doing but have not tried yet?

The Clinical Trials Transformation Initiative (CTTI) will collect all experiences and input by Thursday, March 26 at noon ET, aggregate your feedback, and summarize best practices and insights. We will publically share this information via a webinar (password: ctti) on Tuesday, March 31 at 11:15 a.m. ET.

By exchanging best practices and insights, we can continue our important work to develop needed medical products during this situation, and perhaps even glean some opportunities to do clinical trials better once this public health crisis has passed.

Thank you – we look forward to hearing from you and hope you can join our webinar on March 31.

Diversity in Clinical Trials

Topics Included: Access to Clinical Trials, Patient Engagement

The underrepresentation of diverse populations in clinical trials creates critical knowledge gaps about the safety and effectiveness of medical products—and erodes public trust in research. To help change this, CTTI conducted a project aimed at improving access to clinical trials and increasing the inclusion of underrepresented populations. The resulting recommendations and resources are designed to help organizations implement practical, system-level changes that lead to more diverse participation and research findings that better reflect the needs of all people.

Resources

Regulatory Submissions + Approvals | CTTI News

Share Your Experiences Related to the New FDA Guidance on COVID-19

CTTI Will Collect, Share Findings & Best Practices at a March 31 Webinar Last week, the FDA issued new guidance on the conduct of clinical trials of medical products during the current...

Patient Engagement

Diversity in Clinical Trials

The underrepresentation of diverse populations in clinical trials creates knowledge gaps about the risks and benefits of drugs and devices and undermines public trust in research.

Innovative Trials | Resources

Master Protocol References & Resources

Master Protocol References & Resources

Formats

Stage of Trial