How does clinical trial work?
Say I have a clinical trial testing a drug (X). they randomize patients to 2 arms: placebo and X arms. The patients are tracked for recurrence.
Now, if I'm randomized to placebo arm, and midway in my trial, my cancer recurred+i'm about to die. Meanwhile, the patients in the X arm is receiving great results. At this point, will I be dropped from the trial (becoming the poor statistics in placebo arm) and/or will I be added to the the X arm silently? Does this depend on how well my oncologist is connected to the clinical trial (like on TV :-)?
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At this point, will I be dropped from the trial (becoming the poor statistics in placebo arm) and/or will I be added to the the X arm silently?
You will not be dropped from the trial. In data management and statistical analysis of the trial you are recorded as a recurrence. Usually you would not be added to the X arm.
Whether the treatment within the trial changes for the patients on each arm of the trial depends on the predefined interim analyses and the Data Safety Monitoring Board (DSMB). The protocol for the trial should specify when interim analyses will be done. The results of those analyses are presented to DSMB. The members of that board look at the statistical results for the trial as a whole, not individual patients. If the results are clearly different for the two arms of the study, the DSMB can order the trial to stop and make recommendations for treating patients already on the trial. That can mean that the X arm is so clearly superior that they order the trial stopped with the recommendation that all patients on the placebo arm be given X. It can also mean that the two arms show no difference or the X arm is worse and there is practically no chance that X will lead to better results or the side effects of X outweigh the benefits. In those circumstances the DSMB will order the trial stopped and recommend that patients in the X arm be taken off X.
Does this depend on how well my oncologist is connected to the clinical trial (like on TV :-)?
That should never matter. But your doctor always has the right to change your treatment even if you are on a trial. If that deviates from the protocol you should be taken off the trial when treatment is changed. If the drug is experimental, it may be hard or impossible to obtain off trial. Then how well connected and how far your doctor will argue the case might matter in getting an exception to allow you to get X.
When you are a patient on a treatment trial:
1. Your doctor's first obligation is to you as a patient. That ethically comes ahead of research interests.
2. Your doctor has the right to change your treatment and deviate from the protocol.
3. You have the right to withdraw from participating in the trial at any time. That should not affect your doctor's willingness to continue treating you (although other factors might).
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thanks redsox for the great explanation!
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I need to add to this discussion. This isn't quite right either in most cases:
Say I have a clinical trial testing a drug (X). they randomize patients to 2 arms: placebo and X arms.
It's usually current STANDARD OF CARE vs new medication they are testing. So you would be randomized to one of those arms.
I was in two trials:
- SWOG 0221 to test whether metronomic dosing of AC (weekly lower doses) would be more effective than Dose Dense (higher doses once every two weeks...the group I was assigned to) as hypothesized. They weren't. I don't have the full results, but this came as a surprise. Both were superior to once every three weeks, but it was unknown whether one was more effective than the other.
- A test of Acetyl-L-Carnitine vs a placebo to combat neuropathy induced by Taxol. Here the condition isn't life threatening, and 40% of patients don't get symptoms anyway. I still don't know which group I was in, but I didn't get neuropathy. Here, the intent was to find out if there was a benefit to giving this supplement.
Hope this helps. Good luck. - Claire
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Great replies! Also, in general one can't be in 2 trials at the same time right? Unless they are somehow compatible.
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It may be allowed to be on two trials at the same time, but it would be hard to meet the requirements for two independent clinical trials. You could be on separate trials at different stages of the process, e.g. screening, staging, treatment, follow-up. Trials sometimes have several components in addition to the primary trial that are coordinated (additional components may be optional). That's really one trial but may be like more than one in many ways.
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Dear Jenrio,A lot of useful information can be found on the breastcancer.org site in the section on Clinical Trials.Best WishesThe Mods
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I want to point out that depending on the trial, you can sometimes cross over into the experimental arm.
For example, I did a two-arm randomized trial - one arm was chemo only, the other was chemo with the experimental drug. If progression occurred while on the chemo-only arm, you were then moved into the chemo/experimental drug arm.
This isn't too common, but is something to look for when deciding - I was assured of getting the experimental drug at some point.
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Thanks Claire and Suze and redsox for the tips.
Since the early days after my dx, I have found ispy-2 clinical trials for newly dxed people.
It's the least commitment for patients and could yield a wealth of information sooner about new drugs. So cut down the 15 years and billion dollar price tag of new drugs.
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