There’s been a commercial on the radio here lately asking for people with Type I and Type II diabetes to participate in drug trials for a new insulin inhaler.
How do drug testers manage to test something like this - where if they give the diabetic a placebo they would suffer complications from not having insulin. Or if they are given the drug and it doesn’t work, they would suffer complications.
Same would be true for asthma medication or blood pressure medication.
Seems like it is too easy for it to go incredibly wrong.
This is probably a clinical trial that involves testing a “standard” treatment (not a placebo) against the new one.
Patients would be examined closely before entry. And their progress would be monitored to ensure that their disease is not getting dangerously worse. And to keep track of “side effects.”
As an old “clinical trialer”, let me say that Bridget Burke has gotten it right.
The key thing is to have the placebo group receive what is widely considered to be “standard therapy”. Then, the only difference between the “placebo” group and the intervention group is the intervention (and not the absence of established therapy for the former).
Sometimes, there are disagreements as to what constitutes “standard therapy” and/or whether or not the intervention to be tested is truly felt to be “unproven”. The only example I can think of now to illustrate this problem is in a current trial to examine the role of beta-blocker drugs given to “high risk” patients in the peri-operative period. A lot of potential physician participants felt that the role of beta-blockers in this situation has already been proven and hence declined to enter any of their patients into the study. OTOH, the fact that the study received ethics approval from several HIGHLY reputable bodies was taken as proof that there was “therapeutic equipoise” regarding beta-blocker use in this circumstance. (For more on “therapeutic equipoise” look here about 2/3 through the article.
Are you guys saying that, in the case of this insulin inhaler, they are just going to be testing people getting their same old insulin via injection against people getting it using the inhaler?
Or would it be people getting some other “standard therapy” insulin via inhaler against people getting a new drug with the inhaler?
I guess my confusion sort of lies with whether or not there’s a new drug (new insulin that works via inhaler) or a new method with the same old drug.
If there’s a new method (inhaler) and a new drug (inhaler-transmitted insulin) how do they test that versus the old method (shot) and old drug (injected insulin)?
My BIL participated in a clinical trial and was told he would either receive standard therapy like KarlGauss said or a new treatment. It wasn’t like they would receive no treatment at all.
He was willing to do this because the treatment and medication was free, even transportation from NJ to the UVA hospital and because it was a disease that even with standard therapy was often fatal.
He had good results and found out later he was on the new medication that they were testing. Unfortunately, the medication either wasn’t approved or they decided not to continue the study. Can’t remember which. He continued with the standard therapy and died as a result of the disease.
To add to the others: Many studies have independant safety boards that meet regularly and have the ability to review unblinded data, which means they know who’s taking which drug, as opposed to the investigators and patients who don’t know. If there’s a remarkable finding in one of the arms of a study, they can close down that arm, or close down the study, among other options.
And, of course, there is some risk, which is why they ask for volunteers. There’s an unfortunate public perception that “clinical trial” means “It works, but we’ll only give it to the people we like, or who have the right connections”. Actually, the folks doing the trials would love to give everyone access to a drug they know works, except they don’t have such a thing. The new treatment may be a miracle cure, but it may also be worse than what it’s replacing.
