Have you read the draft guidance posted by FDA on Facilitating Understanding in Informed Consent? The key takeaway is that important information that would impact a participant’s decision on whether to participate in a trial should be presented at the beginning of the ICF process. FDA encourages the use of ‘bubbles’ to highlight key information, [...]
Assessing the potential impact of ICH E6 R3 on Electronic Health Records (EHRs). Help is available! Section 4.3 of the draft guidance indicates that the sponsor should review whether the systems used by the investigator/institution (e.g., electronic health records and other record keeping systems for source data collection) are fit for purpose in the context [...]
The 2021 Annual Report from the GCP Inspectors Working Group was posted on 21 November, 2022. It always makes for interesting reading. Due to Covid, only triggered inspections were conducted in 2021.There was an increase in CRO inspections compared to the previous report. Also of note was an increase in findings related to computer systems! I [...]
Article published on the Applied Clinical Trials website on 12th August 2021 This article can be accessed at https://www.appliedclinicaltrialsonline.com/view/the-future-of-clinical-trial-design-looks-bright
A draft guideline on computerized systems and electronic data in clinical trials! It was issued on Friday, June 18th. It is a 47- page pdf which you can access by visiting the EMA website, clicking on News & Events and then the ‘What’s new’ link and scrolling down to June 18th. I can also e-mail [...]
It is the worlds largest randomized clinical trial of potential coronavirus treatments. As of this morning (Friday May 8th), 9418 participants have been randomized at 173 sites in the UK. What is even more astounding is that the first draft of the protocol was March 10th. It was submitted to both the Regulatory authorities (MHRA) [...]
That was the rallying cry from both investigators and patients at a public meeting on ICH E8 R1, General Considerations for Clinical Studies, held at FDA yesterday. I joined a Webex of the proceedings at different points during the day. The changes to the guideline are significant. It promotes fit for purpose clinical trials by [...]
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 [...]
