After a successful and energetic investigator meeting, your highly anticipated clinical trial locomotive is clicking on all cylinders. Enrollment is ahead of schedule, you’re way under budget and ahead of your timeline by weeks. You might even have thoughts of a record end of year bonus creeping into your head! Then your team identifies an issue and says to you those dreaded words “We need to create an amendment.”
Amendments come in many different forms and usually start with protocol changes. These protocol changes could be for undefined inclusion or exclusion criteria, visit guidelines, new procedures, additional labs, or updates to endpoints. Whatever the reason, this amendment can derail your study fast.
The first step to processing this amendment is to utilize your available resources. Your teams should be coordinating all the possible options for the solution. They will need to go through an internal review process with the Clinical and Regulatory teams, review budget considerations with the finance department, as well as go through a legal review. Next steps after internal approval typically includes an external FDA review, IRB, negotiations with vendors and sites on protocol changes, and signing new contracts and budgets.
In the meantime, the amendment can add complications to enrollment, timelines and budgets for your clinical trial. While waiting for all of your approvals to go through, you may find issues like new budgets need to be updated, timelines being extended, your electronic data capture system (EDC) becoming more complex, additional training is required, and even the discovery of more issues and more frustrated team members.
A single amendment can stop a clinical trial with a freight train of momentum right in its tracks. The next time you’re ready to kick-off your new trial, be sure you have consulted with your vendors, physicians, KOL’s, and double checked your protocol, communication plans, and systems so you’re not a victim to a surprise amendment.