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Mariah's avatar

How and why do we compare drugs to standard of care during clinical trials?

Asked by Mariah (25883points) June 13th, 2018

From what I understand about clinical trials, these days a drug is often not merely tested against a placebo to see if it has any effect, but against the current standard of care drug to see if it has a greater effect than what’s currently available.

Seems to me that there’s a glaring problem with that, but maybe I don’t understand correctly.

Say that drug x is the standard of care for some type of cancer and we’re testing drug y against it. We find that drug y only puts 20% of people into remission while drug x does 30%. It’s not more effective, so we don’t bring it to market.

But what if that 20% of people who were helped by drug y are among the 70% who wouldn’t have responded to drug x? Wouldn’t it still be valuable to bring drug y to market as a second option for people to try if drug x doesn’t work for them?

Am I misunderstanding how this works? Can someone explain this process to me?

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10 Answers

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dabbler's avatar

I think it’s useful to think separately about the % effectiveness of the new drug and the drug company’s decision to produce it.
The costs to finish bringing the new one drug to market might not have any chance of getting repaid if sales would only to the folks who didn’t respond to the other one.
Seems like I’ve seen ads about drugs for folks who don’t get much use out the usual medication, or it needs a boost, ask your doctor about this kind.

Mariah's avatar

@kritiper I understand that much; please read the details of the question.

@dabbler But haven’t the drug developers already incurred most of the cost of bringing a drug to market by the time they’ve completed clinical trials? And they would earn zero of that money back if they don’t sell the drug at all versus selling to few people.

dabbler's avatar

As far as I know, at that stage there is still factory setup for commercial scale production, and market strategy like names, doses and packaging, a large further capital investment.

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Mariah's avatar

Haha I think you still don’t get my question. I understand it’s a logical point of comparison. But aren’t there still some situations in which a drug that performs worse than what’s currently available would be useful? I described one such situation on my details.

Dabbler, that makes sense. Shame so much is money-oriented in this field when lives could be saved.

JLeslie's avatar

Where do you get this information? As far as I know, new drugs to market are tested against placebos. They already have data for drugs already existing on the market.

However, I can see where it can be tricky if it’s important for the patient to consistently be treated. A placebo might be a dangerous option for some people.

Participants sometimes need to leave the study if they are having health problems. They would not be told if they had the placebo or not, that information would not be available until after the study is complete around the country.

There are studies done comparing standards of care, I’m aware of that. For instance, there was a study comparing surgery in carotid arteries that had significant blockage to using a drug, and the surgery was so much more effective they stopped the study before it was over. They decided denying the surgery to anyone was risking their life and unethical.

JLeslie's avatar

Phase 1 they are testing on “healthy” patients a very small group in a clinical setting usually where everything is monitored. This is primarily for safety of the drug. They are testing dosage also.

Phase 2 a larger sample, and patients are not in “lock down.” Lol. Seriously, patients can leave the study at any time of their own free will.

Phase 3 even larger sample.

Phase 4 is when it’s introduced in the marketplace and statistics are taken for efficacy and adverse side efffects.

SavoirFaire's avatar

The standard of care comparison is a secondary criterion that assumes the same patient population. In other words, the comparison assumes that the patients are suitable candidates for either drug. New drugs that do not have a market competitor still might be compared to the current (drug-free) standard of care to make sure that putting patients on the drug is superior—or at least not inferior—to existing therapies, but it won’t be held back in virtue of different drugs being available for different patient populations.

If you’re interested, here is an editorial regarding noninferiority clinical trials from the April 2015 issue of The Journal of Clinical Hypertension.

LostInParadise's avatar

Interesting question. Maybe they keep track of people who had been treated with drug x. It would not be fair to take drug x away from people who found it helpful, but they could note the effects of drug y for people who were not helped by drug x. That way even a modest effectiveness rate of say 10% among such people would make drug y worth trying for people not helped by drug x.

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