Reading the Fine Print

I am not new to the clinical trial experience and I am a huge advocate for patients getting involved in research. I think that patients are sometimes apprehensive to get involved in research. The process can be overwhelming, there is understandable given the potential to tackle understand  40 plus page consent form, the expectations of the scheduling requirements that may be requires, including the number of visits that you may need to attend, taking time off of work for appointments, the potential that you may get a placebo and the potential side effects, just to name a few.

Experiencing new treatments

The flip side is also true, trials can also provide a valuable experience of getting a new treatment that can improve your symptoms and quality of life. Don’t be afraid and arm yourself with knowledge. In my most recent study, I had an experience in which my most bothersome symptoms improved and I was able to gain improved symptom control and quality of life. Hooray!

What to do when the trial is over?

The challenge was, what was I going to do once the trial was almost over? In general, there will be appointment schedules for you to discuss the post-study options with your clinician/investigator. In some cases, you may be referred back to a clinic appointment or to your referring physician for further discussion about your next steps.

"No guarantees"

While there are no guarantees in a clinical study and individual results will vary, the study can be terminated or shortened or new criteria for safety could be introduced. There is also not always a guarantee that you may receive the drug afterward. This is one of the areas that may be particularly ambiguous in the consent form before your participation begins. It is also something that may change during your time in the study. Considering this information may not be clearly laid out, it is something you may want to discuss with the study staff or the clinician/investigator. It is highly recommended that continuation of a drug is clearly spelled out in trial protocol and consent prior to trial initiation.  This is a learning lesson for not only patients but for physicians to teach patients about this aspect of study participation.¹

I am currently in a bit of a negotiation about this exact point, so I highly recommend that those who are thinking about participating in a study have as much information beforehand as possible. I think study centers usually do really well in creating a culture for patients to ask questions. Remember that you have these opportunities available and ask every question that you need to, to feel comfortable in participating in a study.  It has been my experience that you can ask as many questions as you would like about anything related to the study, consent etc. There are some circumstances where they may not be able to share information that could compromise the study but everything else is fair game.

I have learned a lot about the study, my own disease, treatment and mechanisms through participation. It may not be for everyone, but these are experiences that I would not trade.