Q&A with Rebekah Badders, Clinical Research Associate at genae Americas
Q: When should you involve the FDA in your clinical trial planning?
A: Sponsors of clinical trials should begin to have scientific consultation meetings at the outset of any clinical trial planning. As suggested in the FDA Guidance E17, General Principles for Planning and Design of Multiregional Clinical Trials, meetings between regulatory authorities and sponsors early in the planning stages allow for a discussion of the regulatory requirements of the trial, and the data needed to support the application for marketing.
The earlier the consultation happens using the protocol and any relevant documents, the better comments relevant to the trial can be taken into consideration. Sponsors should ensure they note in their submissions how the advice they received affected the preparation of any plans, documents, and decisions about the trial.
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