Appealing clinical trial decision? - 1270782

Sat, 08/15/2015 - 12:58

I'm being evaluated for a clinical trial administered locally for a large drug manufacturer, and the doctor said he might exclude me based on an interpretation of the exclusion criteria that seems obviously incorrect to me. I tried to get a better explanation, but the trial hospital is standing firm that he can exclude me with no further discussion.

Other outside medical personnel that I've talked to see it my way but disagree on options if I am indeed excluded. Some say the doctor has absolute power to exclude me for any reason or no reason, so I'm stuck with his decision. Others say I could theoretically hire a lawyer but it would be more time and trouble than it's worth and better to go to a more distant trial site and try again. Others say I could appeal, but don't know the details of how--through the local site? the drug maker who wrote the crtieria? the independent reviewer?

Whether I'm right or the doctor is right, is there a way to have a timely independent mediator, if I genuinely believe the criteria have not been followed? Or does the doctor have unlimited power to interpret the written criteria how he wants?

This is all so unexpected and puzzling.

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Hi huckstep,

I'm sorry you're in this situation. I can imagine it's quite an conundrum for you to process what's best for you here. I'll ask a doctor/trialist to respond though I imagine it will be tomorrow before we here back. My 2 cents though...waiting for the difference in opinion to be arbitrated or mediated may take longer than you can wait. Forcing the doctor to do what he doesn't feel is best isn't the best way to start that type of relationship but then that may not matter to either of you. Applying for the same trial at a different place if is possible for you to travel there. Trying a different treatment may be an option.

Finally, let me apologize for taking so long to respond it's been hectic on this end of the forum. I'll be more timely in the future.

All the very best of luck,


Thank you! Yes, if he definitely turns me down, I'm very tempted to just apply at the next closest trial. The only problem is that my insurance is slow--took almost two months to get approved initially, and I don't know if I can speed them up if I'm just asking to transfer from one hospital to another. So I'm trying to prepare for if I get turned down and what would be the quickest (or least slow) way to proceed. :(

Dr Pennell

Dear huckstep, I am sorry to hear about your situation. It is hard to weigh in on the exact situation without knowing the details, but investigators (the name for the doctors who enroll patients on clinical trials) are given a fair amount of leeway to interpret certain criteria for entering the trial.

Every trial has a list of "inclusion" criteria, e.g. the type of cancer allowed, the stage, age, number of prior treatments, etc and this is usually pretty clear and not up for interpretation. Trials also include an "exclusion" list, which primarily is intended for safety purposes to ensure someone doesn't go on a trial and end up at increased risk of a bad side effect. The exclusion list also usually includes something like "Any condition that, in the opinion of the investigator, would place the patient at untoward risk or interfere with the trial procedures". Although this last one is most often to account for social issues such as drug abuse which might prevent the patient from being compliant with the study.

I am not aware of any reasonable way to force an investigator to change his mind once he determines a patient doesn't meet the eligibility requirements. It would be reasonable to meet with him/her and ask for an explanation and to explain why you think his interpretation is incorrect. I can't promise that anything would change, but might be worth a try if you haven't yet. And of course, going somewhere else is always a possibility but I realize is not always practical.

I will also say that we, the investigators, really WANT to put people on our trials and aren't usually going out of our way to prevent patients from enrolling. It is very likely that he has a good reason (in his own mind) for not allowing you to enroll, which he might be willing to explain.


I echo Dr Pennell's comment - as investigators, our incentive is to enroll patients on promising clinical trials.
In most situations, you have relatively little legal recourse available to appeal these things, since interpretation of the eligibility is done by the trial sponsor and site. Even as trial doctors, we don't have any recourse to get around eligibility rules. This tends to be very strict, and just as frustrating for us, as for patients.
It could be worthwhile, however, to try another site that has the same trial open.