3 ms·

Does the placebo group get the option of getting the med at the time of termination, or do they have to wait for approval along with everyone else? What about

Does the placebo group get the option of getting the med at the time of termination, or do they have to wait for approval along with everyone else? What about the group already getting the med? Do they stay in?

Gatsky 14y ago
The drug company always continues to provide the drug to those people already getting it, at least in every trial I've ever seen. The placebo group... it depends on the trial. There are some trials where crossover to the active treatment is not permitted, and patients may die without getting it. The problem is that if you allow crossover, usually that means that the trial will not show a difference in overall survival, paradoxically because the treatment works really well. Regulatory bodies such as the FDA demand positive survival data in some cancers before they will approve a treatment. So it can be a difficult ethical issue, because although it sounds terrible to deprive the placebo group of treatment, if you don't prove it works then it won't get approved and nobody will get it outside of the trial. The investigators didn't say whether they allowed crossover in this trial. It probably doesn't matter too much, because abiraterone is already approved and available at the moment for use after patients have had chemotherapy with docetaxel. So for example, patients that progressed on this trial could go on to receive docetaxel which might control their disease for a while, and then after that they could access abiraterone, so they wouldn't necessarily miss out. Is it better to have abiraterone and then docetaxel, or to have docetaxel and then abiraterone? That's an open question, which may never get tested in a clinical trial. Generally the order doesn't matter as much as being exposed to all the agents that are active. In an elderly patient who is a bit frail, I think most patients and doctors would prefer to use abiraterone up front rather than chemo, which has more side effects.
GoodIntentions 14y ago
from the article: "that researchers stopped the clinical trial early to give all patients a chance to receive the life-extending medication"

Gatsky 14y ago

The drug company always continues to provide the drug to those people already getting it, at least in every trial I've ever seen. The placebo group... it depends on the trial. There are some trials where crossover to the active treatment is not permitted, and patients may die without getting it. The problem is that if you allow crossover, usually that means that the trial will not show a difference in overall survival, paradoxically because the treatment works really well. Regulatory bodies such as the FDA demand positive survival data in some cancers before they will approve a treatment. So it can be a difficult ethical issue, because although it sounds terrible to deprive the placebo group of treatment, if you don't prove it works then it won't get approved and nobody will get it outside of the trial. The investigators didn't say whether they allowed crossover in this trial. It probably doesn't matter too much, because abiraterone is already approved and available at the moment for use after patients have had chemotherapy with docetaxel. So for example, patients that progressed on this trial could go on to receive docetaxel which might control their disease for a while, and then after that they could access abiraterone, so they wouldn't necessarily miss out. Is it better to have abiraterone and then docetaxel, or to have docetaxel and then abiraterone? That's an open question, which may never get tested in a clinical trial. Generally the order doesn't matter as much as being exposed to all the agents that are active. In an elderly patient who is a bit frail, I think most patients and doctors would prefer to use abiraterone up front rather than chemo, which has more side effects.

GoodIntentions 14y ago

from the article: "that researchers stopped the clinical trial early to give all patients a chance to receive the life-extending medication"