Improving Clinical Trials

I've always tried to be an advocate for clinical trials. They are important -- we can't get any new treatments unless there are patients who are willing to try them out first to see if they work (that is, they do a better and safer job than the treatments we have now).

I also understand the difficulties that patients have with trials. I am, after all, a lymphoma patient of 10 years who has never participated in one himself. I've only needed treatment once in those 10 years, and my doctor and I decided that an available treatment was my best option. But one of the things I do now as an informed patient is prepare myself for my next treatment, if and when I need it. And for me, that means being aware of the clinical trials that are open to me.

Now, there are lots of reasons why patients don't get involved with trials. Sometimes, that's personal choice, as it was with mine.

But there are lots of other reasons why that might not be about personal choice at all. Sometimes, people are excluded for socioeconomic reasons -- for example, they can't afford to travel the 100 miles to the nearest trial for the treatment that seems appropriate.

Sometimes it's a matter of the way the trial was designed; a patient might me all of the criteria but one, whatever it might be -- a previous treatment, or a seemingly unrelated health issue.

In February, I attended a conference that looked at some of the policy issues surrounding cancer, including clinical trials. One of the speakers was the President-elect of the American Medical Association. She is a community oncologist -- one who has a private practice, rather than working in a large research hospital where trials are likely to take place. She talked about her frustration with trials -- some patients could not get to the closest research hospital, and the trial design did not allow doctors outside of the hospital to give the treatment.

That's understandable, in a way, since for the trial to be useful, it needs to carefully control which patients are allowed to be a part of it. On the other hand, if community oncologists aren't allowed to participate, there is a large population of patients who might want to participate, but who cannot. That's bad for everyone. Patients don't get potentially life-saving treatments, and trial researchers potentially can't get enough patients to participate. (About 20% of publicly-funded cancer clinical trials don't get enough patients enrolled to complete the trial.)

One possible piece of good news is that the FDA, the government agency that oversees trials, is holding a public meeting in a couple of weeks to address this issue. The purpose of the meeting is to get as many people involved as possible who can give their opinions on how to make clinical trials easier for patients to enroll in.

It's a complicated issue -- the FDA plays an important roll in making sure that trials are safe, that the measure the things they say they are measuring, and that the treatments actually improve on what is already available.

While I personally get happy when I see new treatments approved for Follicular Lymphoma, I also get happy (maybe a little less, but still happy) when I read about a treatment that didn't make it out of a trial, or didn't get approved. That might seem strange, but it lets me know the system is working -- treatments aren't being approved without being rigorously tested first. I can trust that new treatments have been shown to work for certain patients.

The FDA has a thankless job -- patients want access to treatments, researchers and pharma companies want their treatments to be approved, and doctors want to be able to give their patients more options. The FDA has to balance all of that and make sure things are safe and effective.  The new push for Right-To-Try laws seems to try to go around the process and push for treatments that haven't been tested enough. (The FDA already has a process in place that lets patients ask for treatments that aren't approved yet, but also allows for some oversight.)

If you are interested in viewing the FDA meeting, it will be available online afterwards (see the link for more information). Some advocacy here would be a good thing -- contact your elected representatives and tell them your opinion about clinical trials.

And, of course, as patients, we can do our part by talking to our oncologists about trials that are available and that might be work for us. If you're in between treatments right now, it's the perfect time to have that conversation, so you can both be ready if and when the time comes.

(Of course, I hope none of us need treatment, ever, but that doesn't mean I'm not keeping myself informed about my options.....)