This is the first in a new series of posts I’m doing in lessons I’ve learned from the ever-increasing number of patients who contact me directly or are readers of this blog who make great comments.
Today’s post is focused on the lack of availability of and exclusions of the vast majority of patients from clinical trials, an issue that I believe many stem cell researchers are largely unaware of at this time.
The standard advice in the stem cell field is to encourage patients to avoid unlicensed stem cell treatments like the plague and opt instead, if possible, for stem cell clinical trials.
An important question remains: just how realistic are the chances for most patients to get into clinical trials?
The answer is that the average patient has at best low odds of getting into a relevant clinical trial for their disease in general and almost zero chance for many individual diseases.
To be clear, I’m not saying I advocate unlicensed stem cell treatments. I don’t. In fact, I advocate against them because I have not seen evidence they are safe and effective.
However, at the same time, we in the stem cell field need to talk more with patients about the realities they face including (A the rarity of and (B) exclusion of most patients from clinical trials.
One can be excluded from clinical trials for countless reasons ranging from one’s age to one’s other conditions to the way the disease in questions manifests in you.
For example, many patients with various diseases contact me and tell me they have tried unsuccessfully to become participants in clinical trials.
Again I’m not saying this makes it logical to get an unlicensed, non-FDA approved stem cell treatment. I think that in fact such treatments have little chance of benefiting patients and many risks. It is somewhat understandable that the designers of clinical trials want to focus on very narrow populations of patients to limit variability in the outcomes.
But we in the stem cell field need to be aware of realities faced by patients. It is so important for all us in the stem cell field to understand as best as possible the obstacles that patients face.
Patients have a lot to teach us just as we can teach them. One lesson from them for me and probably for you too if you are a scientist is that one, as a patient, cannot simply decide to join a clinical trial for one’s particular disease. Trials may not exist and if they do, few patients can join them.