After participating in an immuno. trial overseas and getting randomized to the control arm (Taxotere) and having an ADR, we brought my mother-in-law to the US for an un-randomized trial of an immuno. drug. Her doctors said she had fully recovered from the ADR after tapered steroids. We submitted all the medical records, radiology reports (including one that mentioned "ground-glass opacity"), X-rays, and CT-scans we could get our hands on and applied for "FIR":
http://www.roche-trials.com/trialDetailsGet.action?studyNumber=GO28625
We were told by one hospital with more than 10 trials that there is nothing they could do for her. Luckily, we were told by another hospital, "bring her here." So we did. Then, sadly, we were then told that, because of her pneumonitis ADR, the trial could not accept her. Huh.
Are there additional exclusion criteria somewhere that we could reference to prevent such a false-start in the future?
Reply # - March 17, 2014, 08:40 PM
Reply To: Practitioner-only exclusion criteria for trials?
I'm sorry to hear that your having such trouble finding a suitable trial. Probably the best you can do before traveling to a trial site would be to contact the trial administrator at that site and discuss your mother-in-law's situation as thoroughly as possible. You may also be able to get them to send you more detailed documentation of inclusion and exclusion criteria, but I think the problem is that they may exercise a bit of judgment and discretion in interpreting the trial documentation criteria, and you might not find out where you stand until you show up and they review all your records thoroughly.
JimC
Forum moderator
Reply # - March 18, 2014, 06:18 AM
Reply To: Practitioner-only exclusion criteria for trials?
I agree -- Jim's quite right. I'm sorry that it's been such a challenging experience.
There are sometimes many pages of inclusion and exclusion criteria, and often they are a matter of judgment and debate with the people running the trial. To the maximum extent possible, it would be helpful to speak with someone who does research there, such as a research nurse or research coordinator, who may need to speak with you in detail about the issues, and/or receive some records in advance. Someone who just reflexively says "we've got a bunch of trials -- come out" is just providing a PR response.
-Dr. West
Reply # - March 18, 2014, 11:14 AM
Reply To: Practitioner-only exclusion criteria for trials?
Sponsors are inconsistent about reporting eligibility requirements online. In this case, the inclusion / exclusion criteria posted pubically by Roche seems incomplete. It is probably intended as a layperson summary.
Too much dense, technical information can be sometimes be overwhelming for the audience. It may also make eligibility amendments or changes easier. Nonetheless, I do agree that a more comphrensive listing by Roche of the actual eligibility criteria would be appropriate and well-justified. Too often, the actual clinical trial eligibility criteria is missing from the public, even in the final publication. For example, Roche/Genentech's drug Avastin had fairly narrow and restrictive eligibility criteria, but once it was approved, there was a huge drive to expand the population to as large a market as possible...brain mets, hypertensives, bleeders, clotters, etc. Rarely do clinical trials reflect how a drug will actually be used commercially, for better or worse.