Friday, May 24, 2013

Finding a clinical trial

I use the website clinicaltrials.gov almost every day.  It is something I turn to so frequently that I periodically have to catch myself when I explain it to a patient because it isn't completely obvious how to get a good search result.  I thought I would offer a small tutorial.

The trick is to make a search narrow enough to find what you are looking for without getting overwhelmed by the tidal wave of possible studies.  The second task though is a lot more challenging - figuring out the good studies from the bad ones.  That is a lot harder and often something good to review with your own doc or other patients who are aware of the trial.

Step 1: Go to the webpage clinicaltrials.gov

Step 2: Bypass the front page and go directly to the "advanced search" which is a hyperlink immediately beneath the search box (or click my hyperlink)

Step 3: Enter your search terms - this is where you want to be able to focus your search so there are a few hints.

a-  For search term, I like to either use lymphoma or chronic lymphocytic leukemia.  If I don't get the results I am looking for, I might further clarify, "follicular lymphoma" or "diffuse large B cell lymphoma."  Sometimes you may wish to enter trials for a specific drug like ibrutinib or idelalisib.

b-  On the recruitment tab - I normally recommend clicking on the "open studies... recruiting." Expanded access studies are typically only open for a brief window between the time it becomes clear that a drug is going to gain approval and when it actually gets approved. Those may be available soon for both ibrutinib and GA-101 (obinituzumab).

c-  On the "study type" tab - you pretty much want the "interventional" option - i.e. it has a research drug.  This can cut down on some of the excess studies.

d-  Narrowing down the states you would be willing to travel to can also help a ton.  While some Oregon patients are going to be mobile enough to get to Texas for a study - many wouldn't consider doing that for a study that requires an infusion once per week.  On the other hand, if you live in western Massachusetts, it is pretty easy to get to a lot of major medical centers with a relatively short drive.  While "top flight" medical centers (MD Anderson, Dana Farber, Mayo) are always likely to be loaded with studies - they can be slow centers to activate a trial.  Don't exclude the community practice site with an affiliation to US Oncology or Sarah Cannon.  Major pharma likes those centers because of their speed of opening studies.

That should normally get you to a list that isn't ten pages long.  The next task though is to figure out if any of the studies might fit your situation.

a-  The biggest distinction in this situation is trials for previously untreated patients versus patients with relapsed or refractory disease.

b-  Next- ask yourself it is a randomized trial - if it is randomized, are there any placebos in the study  - randomization is most common in phase III, but can happen in phase II.

c-  What phase is the study
        1. phase I studies are about finding out the safe dose
        2. phase II studies are about figuring out if the safe dose has any meaningful efficacy
        3. phase III studies are whether the new therapy is any better existing therapies.


Once you find a list of studies, and you have figured out if you fit one or two of them, then figuring out if it is a good option for you is the hardest part.

a-  It helps here to talk to people who have been on the trial.  Chat groups like cllforum.com or lymphoma.com can be very helpful in this situation.  You can often find people who have already tried the drug and know what it is like.

b-  Your doc may or may not be all that useful - sadly.  A lot of docs are simply unaware of the incredible advances in CLL/NHL.  I've put together a list of a bunch of good ones who may be better able to guide you than others (ACOR is another great source).
      1.  It may depend upon what standard options you have available
      2.  It may depend upon what you have already had
      3.  It may depend if the new drug has a totally different mechanism of action

c-  When you look at the list of studies and the sites available, often there is a contact person.  Don't hesitate to actually contact that person.  Often they can tell you if a visit would be worth your time.  The docs participating in the study should be able to help you figure out if it is a good option for you.

Anyhow, those are some of the things I think that can help you figure out if a clinical trial is available for you and whether you want to go for it.