The Clinical Trial Game

Three Strikes

Three strikes, but I'm not out yet.  So, the world of clinical trials is often a confusing and, well, clinical.  So far I have looked into and been declined by three clinical trials.  Each for a different reason:  1st Strike - a hospital also offering the trial filled up the slot; 2nd Strike - I was declined because during review of my files they realized I'd had carbo (a certain type of chemo) on two separate treatment regimens; 3rd Strike - insurance denied a portion of the trial but they took so long to deny it the trial filled up.  So, three strikes, but I'm not out yet.

You might wonder if this is going to be one big baseball analogy, well, yes it is going to be.  Clinical trials can be confusing and this is the best way I can think to explain it.  I'm not a baseball person though so if I'm way off base (see what I did there) please let me know!  I think baseball is best because most people understand the general concept of baseball if for no other reason than that it is used to refer to "how far you went" with someone back in the day.  There might not be anyone who knows what the bases are but we all understand the concept of Home Base being the furthest and First Base being the closest right?  Here goes nothing...

Up to Bat

Stepping up to bat means you have found a potential trial that might be a fit for you.  You are going to step up to bat and take a swing at that trial.  You might get a strike, but you will never know if you don't step up to bat.  In order to step up to bat you need to look for a clinical trial, I have a team of nurses that look for me and I also use www.clinicaltrials.gov to search for trials that might work for me.  Once I have enough information I step up to bat, I call the contact for the trial - that could be my oncologist, another oncology office, or even a hospital in another state.

You should hear back from your contact, if you don't contact them again.  It is important to be your own advocate here.  If the contact thinks you are a good match for the trial than you get a hit and advance to first base.  If something happens and you are not a good fit then you strike out and start over again to step back up to bat.

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First Base

Congratulations!  If you made it to first base your prize is to be subjected to a whole series of tests.  This is known as the screening period.  Each trial is going to be different.  The trial I am hoping to get into includes a review of my medical files, a general wellness exam, a wide variety of blood tests, an EKG, and a CT scan.  Additionally there are consults with the trial study nurse and the doctor.

Second Base

I'm hoping to make it to second base right now; second base is the treatment period.  During the treatment period you will receive whatever treatment protocol the clinical trial calls for.  Simple as that.  You will need to go into all your scheduled appointments, watch for side effects, and take all your prescribed medications but in this phase you are simply being treated.

Third Base

In this analogy third base is when you have a monitoring scan and determine that the treatment is keeping your cancer stable.  If this is the case, typically, you will remain on the trial.  If you were to have a monitoring scan and they determine that the clinical trial is not helping than you might be removed from the trial.  You can personally decide to be removed from the trial, the oncologist can decide, the sponsor of the trial can decide, and the FDA can even decide.

Home Plate

If you have made it to home plate, congratulations!  In this analogy the clinical trial worked and your cancer is shrinking; you will typically remain on the trial.  Each clinical trial has a different time frame and exit procedure.  If you come to the end of the trial you will have to follow the exit procedure and monitoring.

Wrap Up

I hope that this has helped you to better understand the game of clinical trials.  As I continue diving into clinical trials I will have more information.  In the meantime, please send positive vibes that I will make it onto second base with this trial and ultimately onto home base!