Lupe & Brian: Welcome to another episode of Sjogren’s Strong.
Lupe: This is Lupe.
Brian: This is Brian. And this is your weekly podcast discussing how to live an active and healthy lifestyle despite a diagnosis of Sjogren’s syndrome.
Lupe: And this week we are going to talk about clinical trials.
Brian: So there’s obvious pros and cons or advantages and disadvantages when discussing clinical trials. And I asked Lupe if she would ever participate in one.
Lupe: And I said, umm, I don’t know about that. I mean, I don’t know. Is did something that I have to swallow. It’s something that I have to put in my eyes. I mean, I don’t know. I’m afraid of the reaction, you know. So, I don’t know.
Brian: And rightfully so. So we did some research and we found some information that we wanted to share with you and we’re hoping for some feedback on this episode, as to you. Have you participated in any clinical trial, in regards to Sjogren’s? And if not, would you consider it or is it just a flat out. no.
Lupe: Well, you know what, let me back it up a little bit. Uh, when I was first diagnosed I was like a few months diagnosed and I was really into, I was reading everything about it, anything. And I came across, I don’t know if it was an email or a post, it was so long ago, I don’t remember.
Lupe: But it was about um, they want volunteers to try the goggles that you put on at night or during the day. And um, I volunteered for that but I was too new. I don’t think they, I wasn’t chosen maybe because I was new, I don’t know.
Brian: Yup. And there’s a selection process with these and before we get into it and some of the pros and cons, there are three phases of most clinical trials. So we wanted to go over those.
Brian: Phase 1, testing of a drug or treatment on healthy volunteers for safety involves testing multiple doses. So dose ranging, they might give some people 10 milligrams and other people, 25 milligrams and other people, 50 milligrams.
Lupe: Phase 2, is testing of drugs on patients to assess efficiency and side effects.
Brian: And then Phase 3, testing of drugs on patients to assess efficiency, effectiveness and safety.
Brian: So now let’s talk about the pros.
Lupe: The advantages of taking part in a trial include.
Brian: You may have a treatment which is only available as part of a trial.
Lupe: The new treatment may work better than the standard treatment, but no one really knows for sure, which is why the trial is being done.
Brian: You could help to improve treatments for patients in the future.
Lupe: You may have more blood tests, scans and other tests completed at no cost to you.
Brian: You may have checkups more often and for than usual at no cost.
Lupe: Many people find it reassuring to have extra tests and appointments, but not everyone does.
Brian: Only you will know for sure about what your feeling is. Do you want to take the time away from work to commit to this test or n not?
Lupe: The research team will explain all the tests and appointments you’ll have before, you have to decide if you want to participate or not.
Brian: So that’s one good thing. You’re going to know, eyes wide open what you’re getting into before you say yes or no.
Brian: So those are some of the pros and some of the pros we’re also going to find on the cons list And a lot of that has to do with, again, how you feel about these things. So, as with any treatment you may have unexpected or serious side effects. So there is a big con.
Lupe: What are the side effects, who knows? The research team will tell you what they know about the treatment so far and what they think the side effects will be. Risk is present with experimental treatments.
Brian: Remember that every phase of trials and treatments have been carefully researched in laboratories before they’re given to people.
Lupe: Phase 3 trials, the doctors know more about the new treatment. So there is less risk of having a harmful side effect.
Brian: So, note to self, if you’re going to volunteer for a trial, it’s a little safer if you’re volunteering for phase 3.
Lupe: Hey that’s true.
Brian: That’s what I’m taking away from this.
Lupe: But maybe you have to volunteer for one and two before you go to three. I mean, I don’t know. I’ve never done that, I don’t know.
Brian: Yeah, who knows.
Lupe: Can’t really speak to it cause I’m not sure.
Brian: Maybe one of you will be able to answer that question for us.
Brian: So other drawbacks include, you’ll probably have to do some extra paperwork.
Brian: Everybody hates paperwork.
Lupe: You may have more blood tests, scans or other tests.
Brian: Which again, can be a good thing. You may have checkups more often and for longer than usual. The extra appointments may cost you time.
Lupe: I thought you were going to say money. I was going to say, hold up, wait a minute.
Lupe: Some people find the extra tests and appointments make them more nervous, but some people find it reassuring.
Brian: So again, everyone is different and this is going to be how you feel about the extra poking, the extra prodding the extra exams.
Lupe: Remember the research team will explain other tests and appointments you’ll have before you decide to enter the trial.
Brian: You know, I just saw my sister this last weekend and I should have asked her a few questions because a, she’s been an RN for 20 plus years. B, she’s participated in a lot of different trials herself. None, none to do a Sjogren’s, but she would’ve had some good insights. So, maybe I’ll talk to her and we can do a follow up interview, after we get your feedback.
Lupe: You know, this reminds me of an episode of Two and a Half Men when Alan, he’s part of a trial or something and then he gets blotches on his face and his hair falls off.
Brian: I remember that episode, that was pretty funny.
Brian: So again, you’re going to have time with the research team. They’re going to share with you all the information that they have about the drug and or treatment and trial process. And you know, then you get to make your decision of whether you do or not.
Brian: Uh, I’m sure not all drug trials are paid, but I know some are paid. You know, my sister shared with me some of the ones she thought I might be interested in. I’ve never participated either, but some of them paid pretty decent money. So, and not that you should just go join every, you know, trial out there as part of an income plan. I wouldn’t suggest that.
Lupe: Just don’t overlap them, right?
Brian: Well again, those are questions for the research teams. I doubt overlapping drug trials would be permitted.
Lupe: I mean what if you don’t tell him just because you want money.
Brian: Then you might end up like Alan from Two and a Half Men.
Lupe: Yes. Yes.
Brian: So one thing we did come across, again and it’s something I’ve seen before a years ago on the Sjogren’s Syndrome website page, they actually have a list of some clinical trials in relation to Sjogren’s Syndrome. And that website for those of you who want to jot it down is info.sjogrens.org/clinical-trials. And that link will be in the show notes below.
Brian: They are organized by city and state. So there might be a trial you may be interested in near you. And then at the bottom of that page they have a few other resources for additional trials. But more importantly we would like to know, have any of you ever participated in a clinical trial?
Lupe: I’ve come across a few posts on Facebook, on all the, you know, the show is pages that I follow, and they asked for volunteers like to use Plaquenil or other eyedrops like that. But I would probably say, yes, maybe. But you know, you have to live in a certain state, which I don’t.
Brian: Right. And they want access to you for test.
Lupe: So, you know, if you don’t live local, it’s probably not worth doing.
Lupe: Some people are more giving than others and I’m not sure where I measure up on this spectrum. I’m hoping that some of you have participated in trials and are willing to share your real world experience. Please reach out and let us know .
Lupe: Until next time, sip constantly and stay hydrated.
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