clinical trial - what questions should I be asking?
October 15, 2013 2:19 AM   Subscribe

I'm considering joining a clinical drug trial. What should I be thinking about?

Here are the details: I'm a sexually active HIV- gay male in the US. The trial is a national study for a drug that may act as a prophylactic against HIV. (Condoms are still recommended.) I met with the clinician last week, and found out that I qualify, but I'm not sure if I want to take drugs that I don't actually need. I feel like I'm in a limbo – I'm not a big fan of taking any medicine, but this seems like a good way to help science while (possibly) boosting my own immune system. And the drug isn't a complete unknown: it's currently prescribed to HIV+ patients. The thought of taking it still worries me.

Any suggestions on how I can make up my mind on whether or not to participate in this study would be greatly appreciated.
posted by anonymous to Science & Nature (4 answers total) 1 user marked this as a favorite
Tell us the name of the drug (contact a moderator to post this).
posted by ryanrs at 3:49 AM on October 15, 2013

Tell us the name of the drug (contact a moderator to post this).
Seconded, if you want to get into specifics.

In generalities, I would want to know:
-whether everyone receives the same treatment, or are randomly assigned to different treatments (and so, are all possible treatments okay with you?)
-potential side effects of all treatments (and their relative incidence)
-visit schedule (frequency of visits, how long are visits, for how long will you be participating)
-what is involved at each visit (e.g., blood draws, physical exam)
-compensation for your time and travel

These things would likely be spelled out in the informed consent document. If not, then staff must be able to adequately give you this information. If not, then I would bail out.

Also, I would take comfort in knowing that you can stop participating at ANY time, for ANY reason. (Note that it would be in your interest to inform study staff of your intention to quit, in case there is a protocol for safely withdrawing you from treatment. It would also be courteous/beneficial to science to inform them, so that they know you are safe and didn't have an "adverse event.")
posted by mean square error at 4:07 AM on October 15, 2013 [2 favorites]

First a disclaimer: I work on a similar, if not the same trial you are considering. Also, my husband is HIV+ and is likely taking the drug you are considering.

Second, you didn't mention your risk. I know you said you were sexually active and I'm going to assume that means you don't have one monogamous partner. In that case, I feel like it's a tool in the toolbox. If you assume that everyone you have sex with is positive, which I think many gay men do these days, it's a very useful tool.

Here's what I would ask.

Ask questions about resistance.

Ask about what happens if you miss taking your drugs.

Ask about failure rates in people taking the drug regularly vs. people who missed doses.

Ask yourself if you are likely to miss a lot of doses.

As far as I'm concerned, these would be my deciding questions if I was to go on PrEP, whether on a study or not.

Please feel free to memail me if you want.
posted by Sophie1 at 6:49 AM on October 15, 2013 [3 favorites]

Former clinical research coordinator here.

Your issues illustrate the essence of Informed Consent. This is a document, which by law must spell out all known risks, benefits, and the overall scheme of the study. Is this a randomized, double-blind, placebo-controlled trial? These are known as the "gold standard" for clinical trials, in that the subjects don't know which study med they receive (placebo or "test article") the investigators don't know, so they can't influence which subject gets which treatment (double-blind, in that neither the subject nor the investigator knows) and randomized, so that roughly equal numbers and types of subjects are in the comparator groups. This makes the comparison valid. And although the site investigators don't know who was assigned to which scheme, there are supervising investigators who can find out if a subject has a problem and they need to know. In most cases where unblinding occurs, the subject is dropped from the study, though he or she is included in the "intent to treat" analysis. Everyone who is randomized to receive one of the regimens is counted in order to have statistical honesty at the end. Make sure you find out if you will eventually know which treatment you received. This will be spelled out in the Informed Consent (also known as ICF) and believe it or not, sometimes subjects are never told. Sometimes there is a "cross-over" group, which starts with one scheme and then "crosses-over" to another scheme. All this study design MUST be explained in detail. This is why ICFs can be 25 pages long.

But Informed Consent is not just a single, albeit comprehensive, document. There should be conversations where every single question you have can be answered, and there is an absolute requirement that any updated information that might alter your willingness to continue participation is conveyed to you in a new, written Informed Consent. For example, if a subject in the study has a heart attack, a new informed consent needs to be offered to you with that information. That person's regimen will have been unblinded.

Is is absolutely possible to withdraw from a study at any time and for any reason. Keep in mind, though, that without clinical trials we can't move ahead with medical research, and the FDA absolutely requires clinical trials before new drugs or new indications for existing drugs are approved. And insurance will often not agree to pay for a future person's treatment unless a drug is approved for that indication.
posted by citygirl at 7:07 AM on October 15, 2013 [3 favorites]

« Older Fresh air in the winter, please   |   Applying for a new job- but what to do about a... Newer »
This thread is closed to new comments.