Medpace medical device experts—who are directly involved with clinical research—presented a webinar on how to avoid the hidden costs associated with conducting clinical trials. Discussed were practices that we employ at Medpace in the management of medical device studies to help our clients run their programs more effectively and efficiently, ultimately saving them time and money.
Audience members asked a number of enticing questions during the Q&A portion of the webinar. Due to time constraints however, we were unable to answer all of the incoming questions from the attendees. Our presenters took some time to address the unanswered questions. You can find their answers below.
How do you get each team member engaged in the process of writing and designing the Case Report Forms (CRF’s)?
Our main suggestion is to avoid email; trying to collaborate on email generally does not work well. Scheduling a web conference with all of the key players is much more effective.
You talked a lot about how the medical writing group works to ensure consistency. Can you please give an example of that?
At Medpace, we have a robust Quality Control (QC) process in place to ensure consistency for deliverables and stock information. Some examples include ensuring that the synopsis of a clinical study report is consistent with the body of the report or that the content contained in a protocol is consistent with the Sponsor-provided protocol of the synopsis. Our QC process covers consistent use of terminology and this really helps to ensure that we don’t miss things that could cause delays in a trial or even cause a regulatory authority to respond with questions.
Can you give some examples of an appropriate endpoint versus a study objective?
Let’s say that you are doing a pivotal trial that focuses on safety and effectiveness endpoints. You are trying to get approval for phase III but your marketing team is involved and they want to collect more information because they want to get marketing claims out of it. This would be an example of adding a new study objective. You need to be careful because it could cause a conflict which can drive higher cost or additional endpoints into the trial that can lengthen it or make it more difficult to execute. Sometimes you can add study objectives in without it being too difficult, but they are often the hidden land mine that can add both cost and time into your trial.
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