Clinical Trial Conundrum

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:

• While you are still anticipating a possible new or different path from your current treatment plan, why not seek another opinion from an expert in medical oncology, specific to ovarian cancer here in the US. Since you are willing to travel to the East Coast Atlantic Islands, why not find a suitable academic institution or clinician before making a final decision.
• Since there are testimonials on the website (which I did review), why not contact one of the patients and get their unique opinion about travel, the accommodations, and the research team experience. Every patient’s response to treatment will be different, but at least you might have some feedback on the rigors of travel and the treatment itself.
• Why not have a frank discussion with your physician and let him know your hesitation. Maybe he can clear up some of the misconceptions.
• While the research I have done with this clinical trial information, I can say that the number of people enrolled is too small and the results too new to know if there will be success. Sometimes, even in the face of possible disappointment with the outcome, it is helpful to be a pioneer for others who follow. Only you can make the decision what role you wish to play.

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?