Protocol Development

The staff and physicians in the Cardiovascular Core Laboratories are available to review the clinical trial draft protocol and provide input to ensure imaging requirements are appropriate to optimize the likelihood of completing the study in an effective and efficient manner. The Core Lab will review all aspects of the study protocol and provide expertise and advice in regards to imaging; the staff will collaborate with sponsors to develop imaging acquisition protocols for each study, as needed and appropriate. Drawing on their years of experience and knowledge of FDA guidelines, the staff is instrumental in formulating instructions for sites acquiring images. These instructions usually address equipment requirements, personal experience or certification and a detailed ‘menu’ of how to acquire the images. The key parameters in the imaging protocol and analysis need to match the goals and objectives of the clinical trial. Often there needs to be a balance between a focused exam that assesses the required fields only versus one that is broader and collects several other parameters that could have potential value in the future. We will discuss the pros and cons of each approach and offer our advice based on the strengths and weakness of the imaging modality and on how those fit your trial objectives.