How To Participate In A Clinical Trial

When I asked you, my lovely readers, to send me feedback, one comment I received requested a post on clinical trials. Well, your wish is my command! I’d like to introduce you to Molly McElwee Malloy, a Clinical Trial Coordinator and Certified Diabetes Educator at the Center for Diabetes Technology at the University Of Virginia. Not only does she work for a clinical trial, but she is a 15-year veteran of type 1 diabetes and has participated in the artificial pancreas clinical trial.


A Guest Post by Molly McElwee Malloy

Molly-McElwee-MalloyHave you ever wondered what it’s like to be in a clinical trial?  Maybe you’ve read an article recently and thought about volunteering?  Let’s talk about it.  First, where do you go to find out what clinical trials are actively recruiting subjects?  Subjects, by the way, are what you are called when you volunteer for a trial.  Here’s some websites that will help you find out what’s going on.


– JDRF’s Clinical Trial portal

– NIH’s NIDDK Clinical Trials portal

Now, let’s talk about contacting the research coordinator to find out more about the trial.  The clinical research coordinator or CRC is your liaison to the study.  They will make sure you are fully informed about the study to ensure you want to do it.  After you have mutually agreed on your participation, you will go through a consenting process that can take some time.  This is the part where if ANYTHING is remotely unclear you ask it.  There are no dumb questions!!!  You are volunteering your time and your body – it’s your right to understand each and every detail that will go on!  If you ever feel like this process doesn’t happen to your satisfaction, there is a phone number required to be on each consent form where you can report this.  Often it will be an Institutional Review Board or IRB phone number.  It is your right as a research subject to be fully informed and feel secure in the knowledge that you know what is about to be asked of you.

All clinical trials have inclusion and exclusion criteria that must be met.  There are good reasons for these conditions to protect both you and the research.  When you volunteer for a trial, you are giving your time and body for the project.  We want to roll out the red carpet and accommodate you.  Here’s the reality – clinical trials are typically funded by grants and they don’t often offer to expense your travel arrangements. Clinical trial coordinators often are juggling the schedule of the facility, the physicians, nurses and other team members that need to be present.  Lots of times all of these things bend to fit when and where subjects are available.  However, all of these things must have a compatible schedule.  I am often astounded when all these aspects align and am eternally grateful to everyone who makes it happen.  We can’t do research without you!

Once you begin there will be certain things required of you.  Just as it is imperative that the research coordinator be thorough with you and your questions, it’s equally important that you do your best to give accurate information and follow the directions given to you.  It’s truly a missed opportunity if you don’t.  Your data matters and we don’t ask for things we don’t need. Do your best to fulfill your end of the research.

In my job, I coordinate artificial pancreas clinical trials.  Before coming to work at the Center for Diabetes Technology I participated in some very early clinical trials of a closed loop artificial pancreas system.  At the time, blood draws were done IV and the system was run by a laptop computer.  My BG numbers were amazing. I remember eating a bagel and not being high afterwards (can you do that?).  It took a lot of blood draws, eating prescribed foods at prescribed times, but the results were worth it.  I got to forget about my diabetes for 24 hours.  After that I realized how much time I spent thinking about my diabetes and how much we needed a better system.  It was one of the reasons I went back to school to get my RN (and later my CDE) and started working at the Center. I want a system that gives everyone with diabetes the freedom to manage their diabetes without losing their minds.  You know what I’m talking about – managing type 1 diabetes is the equivalent of trying to hit a moving target.  You’ll get it right sometimes and other times you’ll be way off mark.  We need a better treatment option and so I’m very excited to be working on this project!

I encourage everyone who wants better treatment options for diabetes to get involved in some way to support research.  Maybe for you it’s joining a walk or volunteering time with ADA or JDRF.  One of my favorite things about the diabetes community is that we stick together and work hard for a better tomorrow.  We know diabetes stinks; we want to have the best treatment options available to make diabetes easier.  We all benefit when we work together.


If you’re interested in finding out more about the artificial pancreas clinical trial at UVA, for more info.

One thought on “How To Participate In A Clinical Trial

  1. As the subject for two trials last year (not-AP related), I can tell you that everything Molly says is true. She’s great at explaining things and helping you understand anything you might not be sure about. Trust me: clinical trials are important! They can’t happen without your (and my) participation. Thanks

Leave a Reply

Fill in your details below or click an icon to log in:

Gravatar Logo

You are commenting using your account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s