Tag Archives: Clinical Trials

Project Mint Tea Still Recruiting Participants!

5 Dec

Suffering from painful knee osteoarthritis (OA)? Interested in parlaying your experience with knee OA into a meaningful contribution to health research? Ready to consider complementary alterative treatments for your knee OA, such as, oh … mint tea?

If you answered ‘yes’ to any of the above questions, you might be interested in Project Mint Tea. If you answered ‘yes’ to all three, then Project Mint Tea is definitely interested in YOU!

Pic Courtesy of J. Mulik

Project Mint Tea is a clinical research study investigating the health effects of a novel mint tea on symptoms of pain and knee joint function in adults with knee OA. Compared to just any old mint tea on supermarket shelves, this particular tea is especially unique because of its high content of rosmarinic acid – a compound believed to help lower inflammation. Lower inflammation = fewer OA symptoms. Well, that’s what the researchers hope, anyways. And that’s what you can help them figure out!

Though initial recruitment began back in August and the first round of participants is already sipping away, we’re still on the look out for more helpful volunteers. If you or anyone else you know might be interested in participating, we would love to hear from you!

For some background information about the study, check out this featured ‘At Guelph’ article. If you think you might be interested in participating, simply click here to view a brief synopsis of study requirements. And as always, if you’d prefer a more personal touch, you’re more than welcome to just get a hold of any study team member directly at: teastudy@uoguelph.ca or 519-824-4120 ext. 56314.

Don’t be shy! We’re super friendly and we can’t wait to hear from you! 🙂

The ABCs of GCP: Therapeutic Misconception Edition

6 Aug

With recruitment for the mint tea study well underway, we’re getting a lot of interest from individuals seeking an alternative “therapy” for their osteoarthritis. From a recruitment perspective, this is great! From a bioethics perspective, however, it warrants some pause for consideration.

Good clinical practice (GCP) is a set of guidelines for the design and conduct of research involving human participants (aka clinical trials). One of, if not THE primary goal of GCP is the protection of participants. Fundamental to this is the informed consent process. Indeed, the informed consent form (ICF) is an essential document for any clinical trial.

Within the GCP guidelines, therefore, is a list of 20 specific items recommended for inclusion in each ICF, including a description of the study, a statement that it involves research, and a summary of the associated risks and benefits. What this list does NOT explicitly address, but is nevertheless an important consideration for ICFs, is the concept of therapeutic misconception (TM).

Though there is some debate regarding the precise definition of TM, it basically is what it sounds like – a misunderstanding that there is a direct therapeutic benefit to be gained by virtue of participating in a clinical trial. Specifically, Canada’s 2nd edition of the Tri-Council Policy Statement (TCPS2), defines TM as “a misunderstanding, on the part of participants, of the purpose, benefits, and/or risks of clinical trials.”

From a researcher’s perspective, what can be especially counterintuitive about the concept of TM is that it is in our very nature to WANT to be able to “treat” our participants. After all, if they’re getting better, then our intervention must be working. But contrary to our expectations and good intentions, it is important to remember that the immediate goal of research is to produce generalizable knowledge, NOT to provide therapy. After all, we’re in research to advance health on a global scale, not just within a single study or a single participant.

As researchers, therefore, it is important that we take precautions to avoid perpetuating TM. This is best achieved by maintaining a clear distinction for participants, and indeed for ourselves, between therapeutic treatment and research. Blurring the lines between the two can be especially challenging when research facilities begin to “feel” like actual doctors’ offices (with their sterile devices and white lab coats), or when physicians become too closely involved in recruiting patients for their own research studies.

Consider this: how many times do you use words like “therapy” or “treatment” in your ICF, or refer to your investigational product as such? Can you see how that may be suggestive of clinical care rather than of investigative research, and therefore potentially misleading for participants?

That being said, I’m definitely not one to preach. In fact, I just caught myself almost typing investigational “therapy” instead of “product” (go figure, eh?).

Definitely something worth thinking about …

Plea from a Novice Researcher

3 Aug

Pic courtesy of J.Mulik

Dear Participant,

Thank you for agreeing to participate in this study. Its success, and ultimately that of my academic career, rests to some extent in your hands. Over the course of this study, I will likely see you more regularly than I do my own loved ones. Seeing as your participation therefore marks the beginning of a significant partnership, let’s just do each other a favour and lay all of our cards out on the table. From my perspective, if you would kindly note the following:

(1) Be totally up front with me.  If you know deep down that you will be unable to manage the requirements of this study, be it the time commitment or protocol demands, then just say so … as soon as possible. I’m sure you’re trying your best to be accommodating, but if you miss too many visits or eventually drop out, I likely won’t be able to use your data anyways. Nor will I be able to get back all the time I spent on you to put towards another participant. You could save us both a lot of stress and frustration if you just tell me straight up that this isn’t going to work. I’m a big girl, I promise I can handle it (and if not, the campus pub is only a few short strides away).

(2) Even though I’m conducting this study, I did not develop everything I’m asking you to do. As a novice researcher, I’m just doing the best I can with what I’ve got. If what’s available is in any way offensive or sub-standard in your regards, I apologize. I did not intend for your particular ethnic group to be omitted on questionnaires, nor did I mean to make you do tasks that are particularly tedious, onerous, or irrelevant to your daily life. These are standardized, which means my hands are tied with respect to changing them. If it makes you feel any better, you are totally within your right to refuse to participate in any such portion of the study. Just please don’t take it personal.

(3) I’m a student not a doctor; please don’t expect a miracle cure. Please understand that the primary goal of this study is to produce general knowledge, not to treat you in particular (though if that happened it would be awesome!). This is still research, which means I can’t guarantee that this intervention will even work. If you’re looking solely for a treatment, please see your health care provider. Likewise, I can’t even guarantee that you’ll receive the actual intervention we’re investigating. There’s a good chance you may be randomly assigned to receive the placebo, in which case, your current condition is likely to remain as is. As much as I would like to help treat you, I definitely can’t promise that I will (please see item #1 if you still have some concerns).

(4) I don’t know everything & my ego is fragile. As a student, I’m still in the process of learning. Please don’t expect me to have all the answers. Even worse, don’t try to grill me, quiz me, or one-up me with your own knowledge base. Being yelled at, interrogated, or belittled by you for NOT knowing something would definitely be enough to make me want to hide out in the bathroom for a little while, and almost enough to make me reconsider my competency as a researcher altogether. If I have in any way come off as a know-it-all, I apologize. I’m probably inadvertently over-compensating for being nervous. That being said, what I do know I‘m happy to share with you, and what I don’t know I promise to seek out for you. Just please be kind and I promise to be the same way to you.

(5) Let’s just have fun with it. Need I say more?

Sincerely,

Your Humble Student Researcher

Research Participants Needed: Project Mint Tea

29 Jul

Pic courtesy of J.Mulik

After much toil and trouble, we’re finally on our way with participant recruitment 🙂 (happy claps)!! As anyone who has ever conducted studies with human participants knows, this is a MAJOR study milestone. For me, it’s the participant interaction of clinical trials that is often the most fun and rewarding … especially following the endless stream of preparatory paperwork that comes from dealing with grant applications, REB submissions, and protocol development.

As such, I would like to take this opportunity to dote on our baby (err… I mean our study), affectionately dubbed “Project Mint Tea.”

This study is the culmination of a joint effort from the University of Guelph’s departments of plant agriculture and human health and nutritional sciences. As well, it builds on several years’ worth of previous pre-clinical research in both cell culture and animal models. It’s no wonder we’re so excited about these next steps!

If you or anyone else you know might be interested in participating, we would love to hear from you!  For study recruitment information, simply click on the “Mint Tea Study” link on the HNRU website. For more information about the scientific rationale behind the study, check out this featured article on the ‘At Guelph’ website. And as always, if you’d prefer a more personal touch, you’re more than welcome to just cold contact us directly at: teastudy@uoguelph.ca or 519-824-4120 ext. 56314.

We can’t wait to hear from you!