Trial Teams and Healthcare Professionals
Patients want Accessible and Inclusive Trials
People we spoke with want trials to be accessible and inclusive in regard to who is eligible for a trial. They also emphasized how important it is for trial participants to be treated with respect. David’s child commented that patients are also not always in a frame of mind to easily make a decision about trial participation, which should shape how researchers approach informed consent. Tiffany said that trials need to be easy and understandable if they are going to be of interest.
Dani hopes diverse people will have more opportunities to be in trials.
Dani hopes diverse people will have more opportunities to be in trials.
It's so important, and I wish there were more opportunities for people with all sorts of disorders, diseases, whatever, to share. So that it was more—people could realize how normal it is to have something wrong with you. And we could move past it and make more—make room for us in society. Because we do have things to offer still. It's just, we might need a little extra something to help us get there.
Liz offers advice for making trials accessible.
Liz offers advice for making trials accessible.
So, if you want to be more inclusive, they need to make sure that those people are able to access the study as well, especially if it’s going to be an earlier phase trial—so whether it’s providing transportation and so forth or having the study in a way that, like I said, it’s more encompassing for all and just easy access. And certainly, being straightforward in what is expected and what you’re hoping the outcomes are in the end. And just that feedback, to me, that’s very important as you go along. You would like some type of feedback. And certainly, at the end, you want to know whether or not it helped, whether or not it made a difference.
Debbie says it is upsetting to be pulled out of a trial because of equipment limitations.
Debbie says it is upsetting to be pulled out of a trial because of equipment limitations.
It was EFT Electrical Functioning Training, I believe. It's where they put electrodes on your legs, and you bicycle. And that's the [NAME] version. That is not the scientific definition of the study. But they put this electrical monitor, if you will, that kind of gives pulsation into your calves and while you're bicycling, to see if that's going to help your gait and your strength and your legs.
Yeah, OK.
And that was not successful, because, quite frankly, I was too fat. My leg was rubbing up against the chair that they had while I was doing the bicycling. And at one session, I actually had some bleeding associated with that. And they pulled me out because they didn't have a chair to accommodate me, which was very upsetting to me. All I needed, really, was a chair with no arms, but they felt they didn't have a chair to accommodate me.
And so, did you just stop participating in that study?
They took me out of that.
Rhonda urges those who run trials not to exclude people based on age.
Rhonda urges those who run trials not to exclude people based on age.
Include us old timers. I mean, I’m 51, and I feel like I’m almost irrelevant in the clinical trial world. It’s like, I’m not going to stop having MS because I’m 51. I’m not going to stop progressing. I’m not going to stop relapsing. Why don’t you think of us, even just a small percentage? How do you know it won’t help? Why do you have preconceived ideas that what you’re doing isn’t going to help us? Maybe it will. You never know.
Patients want Trials that Reflect Their Priorities
Several people emphasized that trials should recognize and highlight patients’ priorities.
Mia advocates for trials to focus on patient-reported outcomes (PROs).
Mia advocates for trials to focus on patient-reported outcomes (PROs).
For doctors, I think the patient reported outcomes should be the point. That's the only way you're getting your information; to know if what you're trying to do is working. There's all different types of patient related outcomes. They do the surveys, or they want you to walk distances, or they want you to do a game or something that they are able to gauge if that's working on you. So, I think questionnaires and surveys and stuff, and the PROs are so important. And if it's a drug trial, for sure a patient panel. Because we know so much more than they do about MS and about our symptoms and everything.
Mercedes emphasizes the need to be transparent with and listen to study participants.
Mercedes emphasizes the need to be transparent with and listen to study participants.
It goes back to the dignity and the respect. And hearing and listening to your patients, your individuals who are your participants. You really need to hear them. You can't just lump them into a group of individuals like, “This is the–the experimental group and this is the placebo group.” You can’t do that. You need to just treat them as individuals and as people. You can't just use them as, “This is my experiment. And, you know, this is what it is”. No, these are people in your experiment. And you need to speak to the people first. And just make them knowledgeable and make them aware of things that are going on. Being transparent is critical as well, because that's when people become frustrated when they don't know what's going on. So, like I said, initially, you as a participant have a duty to read. But then you can ask questions, use your voice to ask questions as well. And then, it's the clinicians in the study to be as transparent as they can be with regards to the study at hand.
Patients want to be Informed and Connected
Sharonda said that it would be helpful for clinical trial teams to connect participants to people who have gone through the same process, so that they could ask questions and get information. Several people said how important it was to them that trial teams share results with participants, and expressed their disappointment when this did not occur.
Karen says there should be an easily accessible database of trial results.
Karen says there should be an easily accessible database of trial results.
I would love if there would be a database for those results that just don’t get mailed back to me. I mean, I personally would love to know the results of them, but I don’t always have the time, or I forget, you know, and I don’t always have the time to go back and research and find them. But I’m very curious to know, you know, what the results are of studies that I’ve been part of.
I wish there was some type of way that you could either be provided with information following the study. You know, or a way that you could easily find that information because I don’t, now that we were talking about that, I don’t know that there’s ever been, in any that I’ve done, any type of like way that you could easily get that information once the study or, you know, the trial is done. Whether it be you provide them the information for them to get back to you or like somewhere that you could even set a reminder for when it’s done in five years, so that you can go in and check, you know. Because, I mean, some of these are years long, and, you know, you kind of forget about it. But I’d love to know what my part in it was.