4 ms·

It's not important that the medication works on an ideal population, it's important that it works on the actual target population. If you can't show efficacy an

It's not important that the medication works on an ideal population, it's important that it works on the actual target population. If you can't show efficacy and safety in your target population who may have several comorbidities and could be taking many other drugs which may interact poorly with your drug, then your drug is a failure in the real world. It therefore is not sensible to test for safety and efficacy on a population that poorly mirrors your target population.

pixl97 10y ago
Eh, it's both. You need a baseline for any testing. When testing physical equipment with a difficult to diagnose problems the easiest way to figure out what is going on is to take the hardware down to a base state and then add one component at a time to see where things go wrong. When you have one population that is positively effected by your drug and takes no other medications it gives a great deal of insight when another population is negatively effected that is highly medicated. We have a problem here in the U.S. that almost all of our old drugs would never be approved these days because of interactions with other drugs and side effects. With the huge amount of medications taken we need the baseline to tell doctors to stop giving patients drugs X, Y, and Z because they would be much better off only taking A.
- refurb 10y ago
  We have a problem here in the U.S. that almost all of our old drugs would never be approved these days because of interactions with other drugs and side effects. That's a huge exaggeration. There are maybe a handful of drugs where the side effects/interactions are so bad that they wouldn't be approved by today's FDA.
sandworm101 10y ago
To get to the "does it work" or "is it worth it" questions one has to first determine what it actually does, what effects the drug has on the human body. For that you want to start with a neutral test subject. As others have said, many drug studies are looking for a degree of effect, whether the drug out performs some other drug already in use. For such comparisons you need a baseline effect. The US population's drug consumption, while certainly the eventual market, is a shifting target. If you want a common baseline for comparisons, the easiest is a drug-free test subject. Also, drugs are tested on groups but administered to individuals. A prescribing doc needs to know the effect absent any other drug interactions. Having a patient stop taking other drugs is always an option. So you need an understanding of how the drug operates under ideal conditions and in the presence of other drugs. Prescriptions remain an individualised medical choice.

pixl97 10y ago

Eh, it's both. You need a baseline for any testing. When testing physical equipment with a difficult to diagnose problems the easiest way to figure out what is going on is to take the hardware down to a base state and then add one component at a time to see where things go wrong. When you have one population that is positively effected by your drug and takes no other medications it gives a great deal of insight when another population is negatively effected that is highly medicated. We have a problem here in the U.S. that almost all of our old drugs would never be approved these days because of interactions with other drugs and side effects. With the huge amount of medications taken we need the baseline to tell doctors to stop giving patients drugs X, Y, and Z because they would be much better off only taking A.

refurb 10y ago
We have a problem here in the U.S. that almost all of our old drugs would never be approved these days because of interactions with other drugs and side effects. That's a huge exaggeration. There are maybe a handful of drugs where the side effects/interactions are so bad that they wouldn't be approved by today's FDA.

sandworm101 10y ago

To get to the "does it work" or "is it worth it" questions one has to first determine what it actually does, what effects the drug has on the human body. For that you want to start with a neutral test subject. As others have said, many drug studies are looking for a degree of effect, whether the drug out performs some other drug already in use. For such comparisons you need a baseline effect. The US population's drug consumption, while certainly the eventual market, is a shifting target. If you want a common baseline for comparisons, the easiest is a drug-free test subject. Also, drugs are tested on groups but administered to individuals. A prescribing doc needs to know the effect absent any other drug interactions. Having a patient stop taking other drugs is always an option. So you need an understanding of how the drug operates under ideal conditions and in the presence of other drugs. Prescriptions remain an individualised medical choice.