The clinical trials sector is highly regulated, and justifiably so. But study startup, one of the most complicated and challenging parts of the clinical trials process, has surprisingly few guidelines. With limited regulations focused on this early part of clinical trial execution, what does it mean to be compliant?
When a clinical trial does not unfold as planned, it may be heading for a rescue. Communication problems with stakeholders, patient enrollment delays, overly complex protocols, and poor site compliance as just a few of the many reasons why rescue action is needed. What happens when a rescue is needed and what can be done to avoid it?
Why are metrics important in starting clinical trials? Metrics are central to efforts to rein in clinical trials that are either poorly initiated or have incurred unforeseen events, which place the original timelines and/or budgets at risk of overages. They also drive competitive performance among those organizations performing trials.
While risk management efforts in drug development have focused mostly on post-marketing drug safety, the clinical trials process has its own mix of potential risks waiting to derail a company's multimillion-dollar development programs. For study startup, a problematic area of clinical trials, these risks include site selection and patient enrollment issues, budget and contracting delays, logistical problems with timely drug shipments, and regulatory hurdles.
Technology for study startup has advanced to the point that Excel never will — automatically trigger workflows as a clinical trial unfolds. It has also become possible to set and track milestones and submissions, improve communications among partners, act as a central repository for study documents, and integration the flow of information from various data sources in a compliant manner.