Without educated communities patients will not enroll – Bree Burks
I’m currently staring at a 52 PAGE CONSENT form. I’ve probably created more than 50 of these personally, and I’ve never been intimidated by them until now.
You better believe I’ve been having the family conversations of “we don’t want her to be a guinea pig” and “why does this include a placebo.”
The fact that the consent goes straight into “we are testing an experimental drug” feels very dehumanizing. There is no lead in about benefits of clinical trials, their role in the approval process or ethical standards for research. What if I couldn’t provide this context to my family? NOTHING ELSE MATTERED without this context first.
Here is what I wish was different:
-A table of contents (I’m tired of scrolling)
-More details on previous study results (as this is a Phase III). It only says “the first clinical data showed promising anticancer activity.” No more information. THIS IS KEY TO OUR DECISON TO JOIN THE TRIAL. HUGE. MISS.
-A video showing the mechanism of action of the drug (I’ve looked in a lot of places trying to understand this better)
-A way I could interactively highlight text and send questions back to the study team. I am coming up with questions in phases. There have been so many phone calls back and forth.
-Sponsor contact info to understand beyond this site what is happening with the study overall? I have a number for WCG to call with questions instead.
I’m asking myself these questions right now:
-What if I didn’t speak English? I saw this as an exclusion to multiple studies. How is that ethical? Who would be answering all of my questions in various phases if I just had one shot at talking with a translator?
-Would a middle schooler understand many these terms (which are not further defined like “radiaoctive tracer”)? How many people are being excluded simply because we have overcomplicated this for them?
-What if I wasn’t a nurse or in the industry? This process is all about accessing people you trust to get feedback. Without educated communities patients will not enroll.
-The “what are the risks of this study” section is 9.5 pages long. Most risks are actually tied to the standard of care drugs (but that is not clear). It feels overly risky without that context.
-It says patient data will be shared with “service providers and partners.” I obviously know this means many different entities, and that feels way under communicated.
-Why have we made it necessary to complete a W9 and show this income on taxes? Such a turnoff in this process.
If you’re wondering the positives around the screening and consent process, I will share those next! THERE ARE SO MANY IT IS A SEPARATE POST!
Interested to hear from the community on improvements that we are making!