The Challenge: Making Adaptive Clinical Trials Operational

The Infectious Disease Division of a world-renowned nonprofit research organization in the Pacific Northwest is the world’s largest clinical trials network for the development and testing of an HIV vaccine. The group conducts all phases of clinical trials, from evaluating experimental vaccines for safety and their ability to stimulate immune responses to testing vaccine efficacy. Due to the nature of their work, researchers at the center frequently need to modify protocols during their clinical trials, either by changing the timing of scheduling windows or by inserting new steps into the protocol, such as adding vaccines or changing dosage, which may require collecting additional consent forms from research subjects.

Here’s the challenge:  if a clinical trial protocol changes in flight (that is, during the course of the trial), clinical-trial management systems cannot handle those changes without a great deal of extra effort. Any scheduling changes, additional consent requests, or other protocol modifications must be tracked manually and will require ongoing monitoring. The more protocol tasks being managed by people, the higher the risks associated with scheduling inconsistencies, missed visits and subjects being dropped from the study. This research organization came to the realization that it was critical to find an automated scheduling solution that would reduce those risks.