Tag Archives: Good Clinical Practice

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 …

Healthy Nibbles: 25 July 2011 Edition

31 Jul

From our eyes to yours … here’s what’s up in health and nutrition news for the week of July 25th, 2011:

As anyone who conducts research involving human participants knows, there is a vast array of paperwork that comes part in parcel with the process. Though the premise behind this mass tree killing is primarily the protection of participants and the encouragement of verifiable science, there has been growing concern that the associated red tape is actually stifling the progress of the research itself. In the hopes of minimizing this administrative burden, the US federal government is proposing various changes to the existing process. Such changes will include centralized ethics boards for multi-site trials and proportionate review for qualitative studies. Sounds great on paper, but the Debbie-downer side of me cautions to wait and see how it pans out in real-life. [NY Times]

Though the token toys of McDonalds’ Happy Meals are here to stay, apple slices will be replacing one half the portion of fries. Acknowledging that this pending change marks a step in the right direction, health advocates are still concerned it represents a band-aid solution in the battle against childhood obesity. And given McDonalds’ notoriously aggressive child-centric ad campaigns, there is particular concern that the addition of apple slices will just mask the Happy Meal’s still sub-par nutritional content. Err … since when did McDonalds even START selling apple slices? From what I could see on TV, I just thought the McRib was back. [TIME Healthland]

What harm can come from a little white lie, right? Okay, that’s up for debate. However, a recent study by researchers from Penn State suggests that modifying standard, child-friendly recipes to incorporate a variety of pureed vegetables can help to increase preschoolers’ daily vegetable intake and decrease their total daily caloric intake. What’s more, the tots still gave the revised meals two (tiny) thumbs up for taste. Now, if only McDonalds could find a way to do something similar with their happy meals (see previous link). [Science Daily]

According to a Dutch study, cranberries fall short compared to their antibiotic counterparts when it comes to preventing recurrent urinary tract infections (UTIs). However, in spite of these feeble findings in favour of cranberries, additional results from this study are giving some health care practitioners cause to reconsider their potential health benefit; in particular, their improved resilience to the development of antibiotic resistance. Proof positive that there is merit in applying some innovative thinking and critical re-evaluating to traditional science. [TIME Healthland]

Is it me or has gluten intolerance and Celiac Disease (CD) really stolen the spotlight as of late? Not to diminish the experience of sufferers or to downplay the necessity of awareness, but heightened advocacy for CD is evidenced by the growing number of gluten-free food products and eateries. In support of awareness, researchers from Sweden and South Africa have just published the first global estimates of CD and its associated mortality. When it comes to health, every little bit of information helps so here’s to many more scientific advances! [Science Daily]