There is so much…
E8 R1-General Considerations for Clinical Trials has been released for public comment. Generally, I like the changes. Like E6 R2, quality is emphasized but the biggest change is the requirements for patient and treating physician input on the design of the clinical study and the selection of endpoints that are meaningful to patients. Patient centricity has been a buzzword for some time, but it is now called out in a guidance document.
There is a whole section devoted to Designing Quality into Clinical Trials which calls for focusing on critical to quality factors that are aligned with a proactive approach.
Some of the language is a little vague and could be open to interpretation by inspectors. I am looking forward to the final document.
Currently 5 entities have submitted comments to FDA and those comments can be located at https://www.regulations.gov/docket?D=FDA-2019-D-3049
The expectation is that it will be finalized and implemented regionally by June 2020.
Patient Protocol Engagement Toolkit
Transcelerate is ahead of the curve and released a Patient Protocol Engagement Toolkit last week. Sponsors and other stakeholders can use it to engage patients during protocol development. The goal is to improve the patient experience and reduce patient burden as a study participant. Hear! Hear! There are lots of resources and references on their website.
https://transceleratebiopharmainc.com/initiatives/patient-experience/
E6 R3- Good Clinical Practices
Just when you thought you have finally come to grips with E6 R2, ICH proposes to revise E6 to anticipate and address a broader range of study types and data sources, while retaining the focus on good clinical investigative site practices and applying a risk-based approach to site monitoring. CTTI is currently soliciting comments from stakeholders on areas in E6 that you believe should be revised and your suggestions on how those revisions should be made.
https://duke.qualtrics.com/jfe/form/SV_a2XzYMfecEgIjsx
E17 Training materials
Finally, training materials for the update made to E17, General Principles for Planning and Design of Multi-Regional Clinical Trials (MRCTs), in 2017, are now available. The aim of the guidance is to increase the acceptability of MRCTs conducted under one protocol in global regulatory submissions. The guidance calls attention to regional variability and its potential to influence study results. A zip file of training presentations can be downloaded from the ICH website. It is so much easier to look/listen to a presentation than read through the guidance documents. I am now a subscriber to the ICH YouTube channel!
I was alerted to all these changes by colleagues on LinkedIn. It has become my Go to place for keeping up with what is new.
Where do you get all your research news?
