What to expect from a clinical trial

Q: What are the odds that I’ll receive a placebo instead of the study drug?

A: Nobody likes doing placebo-controlled trials, especially when you see somebody in pain or covered with psoriasis, but it’s really important to know how a subset of the population does with a placebo. When you are getting your informed consent and learning about the clinical trial, the study staff can tell you up front how many people will be randomized to a placebo versus an active form of drug. A lot of the studies will have a placebo arm for the first 12 or 16 weeks and then they will make sure you get the drug.

Q: Does participating in one clinical trial mean you cannot participate in others in the future?

A: If you are in one clinical trial, it does not mean that you cannot do another one later. It is not acceptable to do two clinical trials at once, though. The problem with clinical trials is that we are really looking at a focused population, and we don’t want any other confounding factors.

Q: On average, how often would a patient on a clinical trial expect to be going in for appointments and doing blood work?

A: I’ve been involved in some trials where people come in weekly. I’ve been involved in some trials that people come in a couple times a week.

Q: Following the trial, can I resume a drug therapy that has been effective for me prior to the trial?

A: You can always go back to a therapy. But if you were on a biologic, and you decided you were going to quit and go over on a clinical trial and then go back to the biologic, there’s about a 25 percent chance your old therapy might not work as well. You can always go back to your baseline therapy. The real question is, will it work as well, and I do not know if it will work as well.

Dr. Jennifer Cather is director of clinical research at Modern Dermatology in Dallas. Dr. Cather discusses clinical trials in the following health webcast. Registration for our health webcasts is always free. You can also search here for a clinical trial near you.

 


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