Project Governance – where to look for Root Causes

Scenario: Your pivotal clinical trial is far behind schedule.  Although CTA (Clinical Trial Application) approvals are beginning to come in, site activations are proving difficult to schedule at sites, you’ve discovered that one of your key vendors will have difficulties delivering devices to sites on time and your study managers inform you that the CRO is warning they won’t be able to meet the timelines originally contracted.  Sound familiar?

There’s no shortage of things that can go wrong when we’re running large (or even smaller) clinical trials.  As we’re trying to “fix” the problem and get things back on track, it’s easy to jump to conclusions and attribute the situation to one thing.  In this case, maybe we blame the vendor.  Or we can go after the CRO… after all, they promised they’d manage our study and they are not living up to their commitments, right?  Unfortunately life is rarely that simple.

Having worked for years overseeing a large portfolio of clinical trials, I have found that problems usually fall into three categories:

  • Protocol-Specific
  • Process and Systems
  • Performance

Protocol-Specific includes things that are specific to the particular study at hand, like competitive trials you didn’t anticipate (timing!), eligibility criteria that end up eliminating an unanticipatedly large proportion of patients or site- and patient burden from a demanding study that ends up being particularly unattractive to participate in.

Process and Systems includes factors like technical vendors, drug supply issues and shortages, shipping problems.  Maybe there are issues with data uploads or transfers or even frequent device malfunctions that frustrate patients and sites.

Finally, Performance includes places where members of the study team are not living up to expectations.  This is rarely a result of poor attitude but more often is an issue of training, skills or motivation.  Most people really want to do a good job and they also want to back a “winner;”  they need a reason to push on when things get tough.

In the vast majority of cases, the full story behind study issues will not fall neatly within one of these three categories.  When studies are falling behind planned timelines, it’s important to completely investigate all three of these areas to unpack the whole story so you can appropriately focus corrective actions.

In our example, we would want to know why it’s difficult to schedule site activations.  Is it because of the device deliveries or because of competitive trials?  Are the device shortages temporary or a long term issue?  Are you and is the CRO managing the situation (and site engagement) appropriately to ensure their interest stays high?

Without scanning all three of these areas for possible root causes, you could end up only addressing part of the problem.

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