Nail in the Tire

Just As I was Getting Started

Last week when I set out for work I realized there was a nail in my car’s tire. I discovered this first thing Monday morning; what a terrible way to start the week.  My car doesn’t actually come with a spare tire so, late to work and unable to drive on the freeway, I spring into action and set out to find a replacement tire.  It was actually all a bit complicated and I ended up having to order an expensive replacement and go two days without being able to drive anywhere at all.  It just wasn’t that disruptive though because my boss was super accommodating and I worked from home.  Instead of meeting my friends out after work, they came to my house.  Not being able to drive to the Nordstrom sale probably actually saved me money (despite the cost of the replacement tire!).  It was an inconvenience for a few days but now I am back in business and it wasn’t a huge setback.

a nail in the tire - beyond your control

A flat tire slowed me down, but it didn’t stop me

Dealing with the Unexpected

There are issues in clinical trials that you can plan for and hopefully avoid.  Then there are issues, like my flat tire, that happen with your vendors, consultants, sites, etc. that you just did not see coming.  Take for example, a natural disaster like a hurricane, flood, fire, or tornado; this could have a real impact on the conduct of your trial.  How about a coordinator who goes AWOL due to a family emergency or health crisis.  What about that subject who left their electronic diary on the bus – oops!  These are the types of issues that you may not have been able to do anything to avoid but they may adversely affect the operations of your trial.

Your responsibility is to contain the impact and avoid letting any single disruption snowball into a series of much larger issues that you could have avoided.  If I had been so flustered about my flat tire that I drove around looking for help, I might have damaged the rim.  I stopped when I saw the tire was damaged and therefore I avoided making a bad situation even worse.

Recovery is Key

So what do you do when something happens that you have no control over?  You react.  The only thing you can really control is your reaction.  Put plainly, things are not always going to go according to plan.  Build in contingencies in your communication plan and study plan for all of your resources, systems, and personnel.  If you plan for hiccups, interruptions, and other issues you may make a much swifter recovery.  The key is to stop, assess the damage, correct the course, and move on in the corrected direction.

Why Did This Happen?

Don’t dwell too long on the setbacks.  I’m all for Lessons Learned, and I encourage you to plan time during your trial, after your trial, and before any new trial to review what worked and where there are opportunities for more operational efficiencies or better quality.  I will caution you though that in the midst of an issue, you should focus on recovery.  Right the ship, patch the tire, and keep moving down the road.

I’m Sure This was Not My Fault

What kinds of roadblocks have you hit in the clinical trials you have worked on?  How did you address the issue and keep the trial momentum going forward?  I’d love to hear about your specific clinical trial challenges and how you overcame them.  Leave a comment, send me an email or join the conversation at the ClinOps Toolkit group on LinkedIn or Facebook.

Other Content from the Clinical Operations Toolkit:

You may also like: From the Lead CRA Blog

Follow me on the Clinical Operations Toolkit Facebook page

About The Author

Nadia

Nadia Bracken, lead contributor to the Lead CRA blog and the ClinOps Toolkit blog, is a Clinical Program Manager in the San Francisco Bay Area.

2 Comments

  • Priya

    August 9, 2013

    That is very true…yes, they are lessons learned, you can only control what you can control- issues you cannot control , you go with the flow.

  • Mandy

    July 15, 2013

    So true! I try to always take these setbacks as a lesson learned. Awesome post!

Leave A Response