Upsides and Downsides of Trials
This summary explores what people liked and didn’t like about being in a clinical trial as well as their relationships with people on the clinical trial team. Many people–but by no means all– said they were satisfied with their experiences.
Effects on Health and Healthcare
Some people said they thought they could tell when the treatment being tested was having a positive impact on their health. Kara described how the medication in one trial made her “start feeling more pre-MS normal.” Others said trials helped with spasticity, fatigue, and inflammation. Some people described benefits in more general terms such as a “100% beneficial.” David S. said his trial gave him “some hope for the future—for possibly something better than it was.” Mia’s trial was critical in her coming to terms with her multiple sclerosis (MS). Rochelle was able to apply what she learned about diet and exercise to other aspects of her life. Lisa said “They monitor me better through the clinical trial. Because they get the scans every three months and stuff.”
People also valued the information they got through trial participation. Mia appreciated learning more about MS and Jim – who participated in a trial right after his diagnosis – liked that he “had all this data that was so much more than somebody else who had been diagnosed at the same time would have and their physician would have access to.”
Being in a trial helped Nora get and effectively use medication.
Being in a trial helped Nora get and effectively use medication.
It was such a great benefit for me because it answered my question, which one is better for me? And so then, I finished. For me, personally, I finished my dosage with the pen, and then the following month, I changed the method to the pre-filled syringes. And so, then I said to her, “If you have any other clinical trials where it doesn't involve medicine, I will gladly participate.” So that one was beneficial for me all around, because I got two months of medicine. Plus, I was able to make a real, informed decision of which applicator was better for me.
Jennifer A. says she benefitted as a person from her clinical trial.
Jennifer A. says she benefitted as a person from her clinical trial.
Like I said, one of the ones that I did at first, that I'm really passionate about, was the one that really was for newly diagnosed MS patients helping cope with the mental uncertainty. And I really owe so much to that study. That truly helped me as a person. I mean, I'm glad I helped science, but I'm also selfishly really benefited. I've recommended that to other people. That one was really great to me.
People described feeling disappointed when trials were not helpful, or were only a little helpful, for their health – or when their disease continued to get worse despite being in the trial. Bianca said it “would have been nice if it had done something.” Linda and Jerry said “None of the drugs really were a miracle drug,” so the trial “really didn’t amount to anything as far as helping.”
Katrina says her cancer spread while she was in the clinical trial.
Katrina says her cancer spread while she was in the clinical trial.
Anyway, it didn't work. The cancer grew. That's when they grew to all my lymph nodes and everything. All my face, up under my chin, and my area of my mouth. Here, it's just everywhere, and there. So be-- that's why this is so swollen. You can feel they're about this huge.
Jason’s expectations were not met when his trial ended up having no benefits for him.
Jason’s expectations were not met when his trial ended up having no benefits for him.
I guess I went into it thinking I would get something, but not knowing what that something was. And then I got nothing out of it. And my expectation should have probably been—like, with what we're doing now I'm expecting to get nothing out of it. I'm doing it because I want you all to have this story to add to the collection, not because I think I will benefit. Hopefully somebody benefits. I don't care if it's me. And if I went into these other things with that same attitude, I might look back at them more fondly.
David R. said clinical trials provided an opportunity to “establish a baseline” for his general healthcare. Katrina and others found trial tests monitoring their health to be valuable. Liz said her trial was a helpful way to get routine bloodwork and MRIs completed. Susan identified and addressed an abnormal lab test result unrelated to the trial that she received as part of a routine trial blood test. Others said trials provided access to better medical care or to coverage for tests and treatments that would otherwise be unaffordable. Nora’s favorite part of being in a clinical trial was getting her medicine for free.
Kara explains how clinical trials help with routine care while uninsured.
Kara explains how clinical trials help with routine care while uninsured.
I haven’t had insurance since 2000—December 2019, and so, I’ve been supplementing with the clinical trial. Because, I had—it’s two different ones I was on at the very beginning, in March 2019, and a different one from now. And it’s been able to help me, be able to see the neurologist. It’s paying for my infusion, and any CTs, and any blood work, because it’s-, it needs for, you know, its stuff. So, I’m able to get-, use all-, use that as my benefit to see my neurologist, and, you know, not have to pay out of pocket, and stuff like that.
Dr. Ellen Mowry talks about people getting access to treatments through participating in trials.
Dr. Ellen Mowry talks about people getting access to treatments through participating in trials.
I think that that is a failure of our health system, right? That leaves people vulnerable and unable to make, you know, informed decisions about participating that are truly, you know, blind of other things.
I’m grateful that there is something I can do. There is a medication that I can get for them through a clinical trial. Because I’m terrified if they aren’t able to access a medication like, how am I going to be able to help them? But that’s ridiculous, right? That’s like living within the constraints of a really broken system. I think that the more equitable thing would be to say, like, you know, say you’re comparing standard of care to a new medication, right? Like, neutralize that experience like they should be able to get the standard of care or medication, whether or not they’re in the clinical trial. I think it’s reasonable to incentive in the clinical trial that maybe you say like, oh, you don’t have to pay the copay or whatever, but it’s not like you can’t get treated if you’re not in the trial.
Downsides of Being in a Trial
People talked about various reasons why trials were difficult or inconvenient. Several people said “it was a pain” having to travel considerable distances, find parking, or go into a hospital for brief study visits. Kara described her multiple, lengthy trial visits as exhausting and possibly unnecessary. Others mentioned that being in trials could be “a ton of extra effort for not a lot of benefits.” Kelsey didn’t enjoy wearing the smartwatch for a year for the purposes of her clinical trial, particularly as she didn’t get to see the data that it generated. Jean didn’t enjoy taking numerous pills and was relieved when the trial was over. Mercedes found MRIs challenging and didn’t like having lab work done. Mia found going on and off pills “downright nauseating.”
Alejandro said having a spinal tap was “not a great experience.”
Alejandro said having a spinal tap was “not a great experience.”
And then to do that, first, I had to go in, get blood work, get a set of MRIs, and do a spinal tap or a lumbar puncture, which was not a great experience. It was all worth it, but I think that it's just something that you wouldn't do it, if you didn't have to, you didn't have a good reason for it. I think this is a very good reason to do it. And I think that for the lumbar puncture, I just think they want to see what's happening in your spine before and after you follow the treatment.
And especially the first one, when they did the lumbar puncture, that was two heavy days—so something to keep in mind.
Ashley wishes blood could have been taken from her son a different way called a PICC line.
Ashley wishes blood could have been taken from her son a different way called a PICC line.
The bad part is that he had to go through with the process because he—because of all the poking and prodding, he was bruised from head to toe because of them constantly needing a blood sample or any samples that they had to have at that time. To me, I wish they just had a PICC in the arm the first day because it would be easier for the kids. That’s the bad part that, to me, if you’re going to poke a kid, it would just be easier to leave something there to get the blood faster instead of leaving the kids bruised all the time. But to me, I know that each kid has to go through a certain process to get things better.
Study Teams are Important
People in clinical trials interact with many members of clinical trial teams including doctors, nurses, coordinators, and clinical technicians. Sometimes the doctor’s people were already seeing become their clinical trial doctors. Other times people have both their regular and trial doctors at the same time, and sometimes people switch their care to the clinical trial team. Though Fred’s trial doctor was also often not present, he appreciated that he was “a legitimate neurologist.” Liz felt “fortunate it was [her] own provider,” who she saw for her other multiple sclerosis (MS) care, running the trial. Debra N. described how she was able to switch doctors to the trial doctor, and she “used the study as [her] doctor’s visit.”
Liz described how after the reaction she had to the medication, the clinical trial team would "work together and figure out what would work best for all the patients and the study.” Fred said his team “treated me like a person all the time.” Susan describes being “really sad” when someone working on the trial left for another job. Liz said, “Any time I had a question and needed information, I always had someone that I could call.”
Jim describes being comforted by his clinical trial team.
Jim describes being comforted by his clinical trial team.
Plus, in the early days, you know like I said, when I was first diagnosed, I just, I was kind of terrified. I didn't know what was going on, and I hadn't really told anybody. And I was going to have this blood work done. And you know the people–the people that worked in the clinical trials, and the nurses, and everything else, they all knew what to say, what to do, how to talk to me, and stuff like that. So that was great. It was very comforting. I just always really appreciated that.
Rochelle explains why she started seeing a trial doctor for primary care.
Rochelle explains why she started seeing a trial doctor for primary care.
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.
Not everyone had positive experiences with their trial teams. Mia talked about the trial doctor only being there for "five minutes to come in and check my reflexes" and otherwise having students who she didn’t feel were qualified doing the work. Elaine said in her trial, “the whole crew was always changing." For Debra N., turnover in the trial coordinating position meant that she never knew “who I could call.”
Mia did not feel that members of her clinical trial team were always “on the same page.”
Mia did not feel that members of her clinical trial team were always “on the same page.”
And after I went in that second time, and the guy never got back in touch with me to do the final on the study or anything. When I went back to do the medication study for fatigue, I went back to [INSTITUTION]. And I'm like, well, [NAME] is the one who was head of this study. And she's like, “Oh, he's here.” And he comes out, and he's like, “Oh, I just didn't hear from you.” I'm like, “Yeah, because you didn't write me back.” And I just felt like it was too many loose ends, you know what I mean. And I'm not a doctor so I don't know what it takes for you to get together a study and everybody to be on the same page. And it seems like it's a large group of people. Not all the time, just like these people in the room kind of thing.
Mercedes describes her negative interactions with one of the trial team members.
Mercedes describes her negative interactions with one of the trial team members.
But my experience was good up until the end. I ended up moving back home to the [LOCATION] area and I think they felt as if they'd lost touch with me, but just their persistence and—kind of a nagging to an extent—it just irritated me. And the tone in which they chose to speak was not very welcoming or positive and so that's why I elected to leave the study. But, I think, one of the individuals who was working with them, I didn't care for the tone that was presented. And that was it.
It's just the tail end when someone else was brought in the study. And I had worked with this individual for some part of the study, but just towards the end. I don't know if it was because she was concerned about me. I know that she said that, but there's being concerned and then there's the way that you speak, and you share that concern. And I didn't appreciate that. You know, I was an adult. I am an adult. And she's an adult. And so, there's a way to speak to people. And I didn't appreciate that whatsoever. I elected, because of her specifically, to leave the study.