|
Abstract:
|
The review of clinical trial protocols is designed to protect patients and ensure a trial’s scientific validity. While an important part of the research process, scientific review may result in changes to the trial design, unrelated to safety concerns, that are inconsistent with the study’s original objective. Strong collaboration among the research team can facilitate constructive correspondence with review entities, which may successfully protect the research’s original intent. In other cases, the principal investigator may face the difficult choice of either complying with the required changes that modify the study intent or losing the ability to carry out the study. This presentation outlines three early-phase trial examples: two examples in which the scientific review process altered the study’s initial aims, and one in which the research team and reviewers were able to find common ground on the proper design to meet the study’s research objectives. In all examples, the reviewing body included a requirement to use an antiquated dose-finding algorithm with poor operating characteristics which was unable to adapt to the studies’ intricacies.
|
