Archive | October, 2013

Human Clinical Trials: Expectations vs. Reality

8 Oct

Written by: Marron Law

Image courtesy of Marrow Law.

Image Courtesy of Marron Law.

It wasn’t until my third year in the Nutritional & Nutraceutical Sciences (NANS) program that I learned about clinical trials. Interested in research, but not particularly drawn towards pure lab work, I started to realize that clinical trial research might be a good fit for me. Therefore, the opportunity to help with a clinical trial investigating a functional food came at a good time when I was fortunate enough to receive an Undergraduate Research Assistantship (URA) working in the Human Nutraceutical Research Unit (HNRU) this past summer.

I’ve since come to learn that reading and learning about clinical trials is very different from actually coordinating one. To highlight this, I’ve created a list of the three things that I found most unexpected about clinical trials.

1. The amount of organization. I hadn’t realized how many documents are required and how much information needs to be documented. The REB application, usually at least 50 pages, was just the start. Three consent forms, instead of the one I had expected, and over 15 different documents were needed for each participant! Almost every interaction with a participant, whether through phone, email or in-person, is logged. Reminders must be emailed before every participant visit and product numbers and expiry dates for all food items given must be recorded.  Although I wasn’t expecting this level of organization, I have learned that in research, especially involving humans, attention to detail is key to reducing error, maximizing efficiency and a successful clinical trial.

2. Recruiting is hard. How slow and long the process was to recruit participants is rarely captured in a research article. Recruiting is not easy. Not every eligible person wants to be in your study and not every person who wants to be in your study is eligible. Of the 150+ people we’ve screened, only 12 have gone on to become participants. We’ve put up posters all over campus and the city, and have posted online and newspaper ads – multiple times! Still, we find ourselves waiting for a phone call or email, hoping the next person is willing and eligible.

3. The unexpected problems. As with many things in life, it’s unrealistic to expect a clinical trial to go off without a hitch. There’s opportunity for all sorts of problems to arise, such as non-compliance with protocol, scheduling conflicts or the grocery store running out of a product you need, just to name a few. While sometimes frustrating, such events are a normal part of clinical trial research and provide opportunities to develop strong problem-solving skills.

This summer was, without a doubt, an invaluable experience to me. It has taken all my preconceptions of clinical trials and given me a reality check on how it really is. However, none of this has dampened my interest and I’m still very keen on doing clinical trial research. So for all those who were like me and only had experience with clinical trials through research articles and the classroom, please know: clinical trials involve lots of files, lots of waiting, and lots of problem-solving.