Ending the Trial
People we spoke with had a range of experiences with the end of their clinical trials. Some stayed until the trial was over for all participants. Others left before the study was complete. In a few cases, the clinical trial team ended someone’s participation in the trial because of side effects or other medical problems.
Deciding to Leave the Trial
Some people decided to end their clinical trial participation themselves because they were concerned about whether the study drug was working and wanted to continue instead with medications that had already been approved. Dani withdrew because she was concerned about whether her personal information would be revealed. Others stopped participating because of how they were treated while in the trial.
Mercedes describes withdrawing after being treated poorly by a member of the trial team.
Mercedes describes withdrawing after being treated poorly by a member of the trial team.
I assured her that I have the medication. But then she calls back again. She said, “We can't find you anywhere.” Blah, blah, blah. Well, you have my information. You have my address. You have my telephone number. Call, leave a message, or what have you. Don't keep calling. And don't share or voice your concern in the manner in which you're doing it. That's what I did not appreciate. You know, she was kind of reprimanding me like I was five or something.
Got it.
In any, you have the option of leaving whenever you choose to for whatever reason. And there should be no repercussions. So that's what I chose to do.
Got it. What was it like for you to stop the trial?
It was easy. Thank you, but no thank you and left. Yeah. Nothing—you know— nothing more, nothing less. Nothing physically, nothing emotionally. I'm just not—you know—the stress was off me just by the fact that I didn't have to you know interface with that individual any longer. But I felt bad for the other individual with whom I worked with from the beginning of the study. And then I still had a positive relationship with my physician, you know [NAME]. With her, you know it was no love lost.
Alison and Matt did not consent to a trial which would result in a lower chemotherapy dose for their child.
Alison and Matt did not consent to a trial which would result in a lower chemotherapy dose for their child.
Do you remember if you were offered the opportunity to take part in any clinical trials or experimental treatments?
Matt: We were, I think we agreed to everything but one of them maybe.
Alison: We agreed, and we were on the trial, but when it then came time where you had to make a decision about whether you—there was like a certain—so, they were always keeping track of her progress or whatever as part of a trial. I think all the treatment is sort of part of a trial, but then there was a part where it was going to really be a trial ...
Matt: Well, it was because they wanted her to take less medicine, and they were like, “Oh, we’re trying to figure out if we give less medicine. We’ll have less side effects, because it looks like according to this one study, you don’t need all the chemo we’re giving them. You know, we’re giving this, ‘cause we know it works,” which makes sense. They’re like, “So do you want to be part of that study?” And we were like, “We don’t want anymore of that study. We’re going to stick with the 90 percent,” with--you know, but other, you know, and that was hard to come up with, ‘cause we understood ...
Alison: We spent a lot of time ....
Matt: ... the benefits of people being part of studies. That’s how we got to 90 percent in the first place, right? So, but I was like, “I don't know if I can deal with giving her less medicine and then something happens.” I would, I don't know what I would do. So, we said no to that.
Teams Stopping Your Participation
Some people were asked to leave trials while they were still in progress because of side effects or other medical concerns such as increased depression, infections, and abnormal blood work. Study monitoring visits were an important time when any negative effects were noticed and addressed by the study team. Debbie’s clinical trial team withdrew her from the trial because they were concerned the trial medication may have caused severe depression.
Kara had to leave her trial due to side effects.
Kara had to leave her trial due to side effects.
They knew about the IGM levels would be low, and they had a window to where you can get it, like, to get it brought back up. But if you don’t get it brought back up, they would eject you from that trial, because I mean, you can’t get the medicine. So—and they give you—and then you can extend it, too. If you want to try it for, like I think I extended it a month—I was able to do that too, because I told them everything, I was doing in order to try to bring them up. And they were like, “Well, let’s extend it another month and see. Keep doing what you’re doing.” And it didn’t work. And it didn’t work enough, rather, it worked like two points. And they actually ejected me from it, but I wasn’t penalized for it. I could not help that I—the medicine caused this. I—it’s not my fault I couldn’t get it back up.
When Susan’s participation ended abruptly due to side effects, she wondered about the trial’s outcomes.
When Susan’s participation ended abruptly due to side effects, she wondered about the trial’s outcomes.
It was sort of abrupt. You know, because you're just kicked off because you can't continue if you have the side effects. And it was just sort of kind of like, “Oh, I'm done.” So, I mean I have to be done, because I couldn't continue. I had to stop taking the medication. But there was no follow-up other than me asking my neurologist, like, “How did it go? And did the drug finally get on the market?” You know, and then I knew, yes, it did. And, yes, your side effects were the major ones that most people, a lot of them, had.
Other people we spoke with participated in clinical trials that stopped for all trial participants before the expected end date. People talked about trials that were ended out of concern for patient safety or when early analyses revealed treatments were not beneficial.
Bianca did not feel upset when informed her trial had abruptly ended.
Bianca did not feel upset when informed her trial had abruptly ended.
And then just getting this phone call at work, from the nurse in my doctor's office, saying, “stop immediately," that's kind of all I remember about Linomide. And I don't know what's happened with it, if it's just permanently not a possibility. I don't know. But there was nothing—I don't remember any suffering in any way from the medication except for the little dry mouth thing.
Well, it was just a little scary. I wasn't somehow personally afraid for myself. It was sort of shocking. But even though I tend to worry about other things, I did not—like at work, I was able to continue teaching my little kids their music classes that same day. It was not in any way traumatic. It was just sort of like, “Oh, OK, that's weird.” It didn't really upset me. And I didn't pursue it. I don't think I even read about it to see, what's the deal with this medication? So, it didn't really affect me for some reason. I don't know why.
Ending the Trial as Planned
Many people we interviewed remained in their trials until the trial goals were met and the clinical trial team ended the trial for all participants. Debra N. learned about an adverse event that occurred during her study and decided to continue because she’s “one of those people who like to finish things up. And so, I stayed with it all the way till the end...I met another goal. I made it till the end.”
Rochelle talks about her final clinical trial visit.
Rochelle talks about her final clinical trial visit.
Well, I came and did the blood—well, I had to do the blood work. I did an MRI, did the blood work. Then they just came in and I had to do a physical. It's like a physical where you walk, jump. And then you do different obstacles. And then they just grade you and everything. And then I talked to Dr. [NAME]. So, it was good. It was a nice ending. I didn't have problems at all. And I hope it benefits somebody. Hope it benefits everybody. Everything checked out for me, which I'm glad and thankful about.
Getting Information Back
Many people had questions about what information they would get back at the end of their trial. Sometimes clinical trial teams shared overall trial results with participants. Debra C. said that the results of one study she participated in were published in a lay audience multiple sclerosis (MS) magazine that she was able to read. A number of people said that there may be a big-time gap between when a trial ends and when the overall results are published.
Sometimes clinical trial teams shared trial results published in peer-reviewed journals directly with trial participants. When results were not shared this way, some people tried to find results themselves and others did not. For instance, when Sharonda’s child’s trial ended, Sharonda “walked away from cancer” and “never looked back.”
Jason says he is interested in study results and wants them to be provided.
Jason says he is interested in study results and wants them to be provided.
And I know any time I participate in a study or a trial or something, the only benefit that I would like to get out of it is, when you publish, please send me a copy, because I want to know what the findings are. I want to know, what did you learn? You spent all this time and you've paid your team of researchers and you put all this work into it. What did you learn? And I'm hoping one day someone says, “Well, we learned that this cures MS. We learned that this re-myelinates the spinal cord.” That's what I'm hoping for one day, hopefully. Back when I was diagnosed, I was told we'll have a cure in five to six years. And now they're still saying five to six years.
Always five to six years.
Yeah.
Have you ever been given the results of a study?
No. But I've also always been told these research studies are ongoing. We might not publish for a decade. So—but no, never gotten any results.
Have you ever gone online to any recently, to try to find the answers?
No. I want it to be easy for me. I want it to be given to me. And if I have to do any digging—like, if I'm going to be googling something to look for an answer, it's going to be a tax topic. It's going to be something that's very—that's more relevant to—well, I shouldn't say more relevant, because MS is very relevant to my life. But something that I think will help me. And I don't—I guess at this point learning something new about MS isn't going to significantly affect my life.
Susan says she would have liked to see the results of her trial.
Susan says she would have liked to see the results of her trial.
And it sounds like you didn't get any results back either about yourself or about the group.
No, but I would have loved to have seen it. And I don't know why at the end you can't, but I know it's all their secret little data that they don't want to share. But it would be– it would be a nice thing at the end of the study to know. And I don't know why you can't because look at the COVID vaccine. I don't know if you have, but I've read the study stuff online, and you can see the percentage of people and how much– what they're– I would have loved to see it. So if you can see it for that, like you see it for mine. So I would have loved to have seen a statistical thing saying these people– this number of people got GI disruptions, this number of people got these symptoms. And maybe you could Google it now and see it—I don't know—in there, because it's on the market. But I just would have liked to have seen some of that statistics.
I didn't mind sharing my data, but, like I said, I would have loved to have got something back. It doesn't– doesn't bother me to share the data. That doesn't bother me at all. No. I just– I just wish I could see something back. Just to know how you ranked or where you were, because it's like you know, it is just interesting to find out.
Fred was disappointed that neither individual nor overall study results were shared.
Fred was disappointed that neither individual nor overall study results were shared.
Have you gotten any results back from the clinical trials or other information?
No, I don't know. And they kind of said, I think in the last consent form, that I wouldn't necessarily get anything back from them as far as that. That was their information, they use it the way they saw fit. It's not that they'd exclude me on purpose, but they just never came. They made it pretty clear that I wouldn't necessarily get anything from them. I know because it would have been nice to have gotten the last MRI copies or whatever. I could have given it to when they had to do one here because I did one right before it. It was a shame.
Treatment After the Trial
After the completion or ending of their trials, some people, such as Debbie and Liz, continued on the treatment tested in the trial. David R. learned about physical therapy in his trial and spoke with his doctor about continuing it afterwards. Debra C. also asked her doctor if she could continue the treatment that had been working for her during the trial but was not able to do so. Debra N. decided to stay on the medication she had been taking for 10 years on the clinical trial. Others, like Rochelle and Jim, switched to non-trial medications. Other people talked about not knowing whether their insurance would cover the trial treatment once the trial ended and being concerned about this.
When her trial ended, Elaine was unsure whether Medicaid or the study sponsor would pay for her medication.
When her trial ended, Elaine was unsure whether Medicaid or the study sponsor would pay for her medication.
Oh, it was, yeah, it just ended. They were done. And you go, “Aren’t you going to wean us, you know, slowly take us off?” And they go, “No, we’re done.” Like we just found out and just like, okay. So all they did is I have two-year prescription, two years’ worth of medication I can get. Now I don’t know if insurance is covering that or they are. I don’t know because I’m on Medicaid. And I know that they approved it and said I can get it.
Liz describes her experiences with insurance coverage for her trial medication.
Liz describes her experiences with insurance coverage for her trial medication.
So, when you ended participation in the clinical trial, how did that work in terms of going from the trial drug to the drug that you were responsible for yourself, I guess, in a way?
So, it actually didn't go horribly bad, because it had been FDA approved. And then I know that they were quickly working on getting the insurance companies to pick it up. So, by the time I was through the study, the insurance companies, they were working with it. So as far as the facility that I attend, those nurses, the infusion nurses and so forth, they knew what they needed to do to work with the insurance companies on that respect. So, I really didn't have too much trouble switching over. And then I also found out that Ocrevus has a copay program, which is wonderful. Because I probably would have never been able—I would have been working forever to pay for it. So, while Ocrevus is not the most expensive drug to be on, it's at least $60,000 a year for that medication. It's probably more like $65,000 which is phenomenal, but it's not as bad as some. So, they do have a copay program. So that's the only thing is a lot of different drug companies that I found out do have assistance with your copays. I think Tecfidera, they actually have one as well. So, I was able to switch over fairly easily because of that program.
Rochelle decided to continue seeing the doctor from the trial.
Rochelle decided to continue seeing the doctor from the trial.
So, who else is part of your care team now? So, you have Dr. [NAME], and then who else do you see that is taking care of you?
That's it. That's the only person. She's getting ready to be my primary care. Since the study is over, I'll be going to her for primary care now. And I didn't have a primary care. I went to [INSTITUTION]. I had a primary care over there. But now I'm just going to go straight to Dr. [NAME] now, starting in April.
And what led to that decision?
Just that I trust her more. She tells me more information that definitely benefits me and helps me. No matter what I ask her, she's always told me what I need to know. And she always lets me know what I need to know. Just to help me to go farther and do better. So, I just trust her, with my health and everything. So, I feel more comfortable going with her. I couldn't wait to ask her if I could continue to go with her—I mean, go to her. So now I'm glad I'm able to go to her full time.