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 [...]
The recent draft guidance on Risk Based Monitoring (RBM) suggests that sponsors consider this when determining the timing, types, frequency and extent of monitoring activities. ‘The research coordinator serves an important role in ensuring the quality of the investigation at the investigative site…. the research coordinator often recruits subjects, collects and evaluates study data, and [...]
This is a no-brainer! You can ensure early in the enrolment phase that procedures are being done correctly. If not, a CAPA can be implemented sooner. The recently issued FDA draft guidance on Risk Based Monitoring (RBM) extols the benefit of an early monitoring visit or other early monitoring activities when determining the timing, types, [...]
Location where subjects will be seen: a factor to consider in monitoring activities The recently issued draft guidance recommends that the location where subjects will be seen (and how the data will be collected) relative to where sponsor oversight activities will be conducted, should be a factor you consider when determining the timing, types, frequency [...]
The recently issued draft guidance on A Risk Based Approach to Monitoring of Clinical Investigations recommends that turnover at the clinical investigator site or among monitoring staff be one factor you consider when determining the timing, types, frequency and extent of monitoring activities. Turnover at the site Historically a change in personnel at the investigative [...]
Communication or lack thereof, miscommunication and poor communication. It is considered a soft skill but in clinical trials it is a critical skill. I have identified 5 stages in the clinical development cycle where communication is of critical importance. 1. Protocol development Don’t wait until your protocol is finalized before seeking [...]
