In a Phase 3 Randomized Trial would I know if I had received the experimental treatment or not?

It depends. In the interest of scientific validity studies are best if they are double blinded. This means that neither the doctors nor the patients know which of the arms the patient is in. However, in some studies this is impractical or even impossible, For example, you may have one study testing the effectiveness of radiotherapy versus drug therapy. In a study like this where one arm receives the radiotherapy while the other arm doesn’t, it’s obvious to everyone concerned.

What if I don’t like the arm to which I’ve been randomized?

In this case your option would be to drop out of the study altogether. You can’t demand to be in the other arm.

Obviously, before you actually enroll in any clinical trial you need to find out as much information about the trial as you can. Even though a lot of the information will be listed in the trial listings as we’ve seen, you should definitely talk to the doctors in charge of the trial.

You may want to ask more specific questions about what they are testing, why they think the trial is promising, the results of earlier phase trials, the design of the trial, how long the trial lasts, what happens at the end of the trial, what you as a patient will have to undergo in terms of tests and visits, and any other questions that you might have.

You may need to ask if there any costs involved. You definitely need to talk to your insurance company to see what they will cover.

At the end of all your questions you will have to sign an informed consent before you are allowed to enter any clinical trial. This consent says that you are aware of the risks inherent in taking part in the trial.

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