A group of several ovarian cancer patients have either called or visited me in my office recently to ask for information and validation to begin a vaccine clinical trial on a tropical island in the Atlantic.
A group of several ovarian cancer patients have either called or visited me in my office recently to ask for information and validation to begin a vaccine clinical trial on a tropical island in the Atlantic. While this is not my area of expertise, I did do some research for these patients and what I found was a bit troubling.
The number of research subjects is too small, the first trials were with melanoma patients and not ovarian cancer patients, the price of enrollment is in the thousands of dollars, and the research team consists of just four people.
It is difficult to comment on a study that did not receive Institutional Review Board (IRB) approval at our hospital prior to enrollment. The number of patients enrolled is so small and mostly focused on another tumor site, it would be unethical to suggest that this could be successful or not. But when some of your patients have no hope left, and they are willing to spend thousands of dollars on enrollment costs and travel arrangements, what is the correct response?
This is what I ultimately told those who sought my opinion:
I am not sure I was helpful to these wonderful women who looked into my eyes and wanted to hear only positive response. It is a huge responsibility to walk between research trials and patients desperate for a cure, but as practitioners, we have to protect our patients as well.
I am wondering what you would do in this case? Have you ever had to respond to questions about clinical trials and their ultimate value?