If pt in randomized trials gets worse, what do you do?

There are at least two recourses:

 

1. most trials, especially one arm is a proven effective treatment, some protocol allows so-called "cross over",  meaning allowing pts in placebo arm to use the treatment of the other arm. In that case, if protocal allows, pt in placebo arm can get remedivir if his or her condition gets worse. The downside of this approach is it would make benefit of the effective arm more difficult to discern. 

 

2. Allow other known effective treatment to be used and no "cross-over". In that case, convalesant serum should be used regardless which group patient is allocated to, which should also be part of the research protocol. Failure rate in each arm will also be used as an indicator of effectiveness. 

 

Could that pharmacist tell the pt's family that her mother is in the placebo arm? 

 

Most likely not. He or she is a trained professional and should know the rules and  has no right to "un-blind" the patient. Did she know who got remedivir? She might, because she is involved in dispensing the medication. Remedivir is an injectable, not pills. The placebo should be saline water. Most likely she knows. 

 

Another explanation is that  the pharmacist could have said that the patient could have been randomized to the placebo arm and it was misunderstood.  

所有跟帖： 

• pharmacist has no right to tell anybody nothing regarding pt's -Timshel- ♀ (0 bytes) () 05/21/2020 postreply 09:54:34

• Dropped out, -fuz- ♂ (0 bytes) () 05/21/2020 postreply 10:21:40