What Patients Want from Clinical Trials, with a Multi-Time Clinical Trial Participant
Rucha Shah is a patient advocate who has participated in several clinical trials. She shares what has made the difference in saying yes or no to a trial, how sponsors have made participation easier, and what she would like to see done more in the future.
What has been your driving impulse to participate in clinical trials?
One of the major factors is finding more pros than cons with clinical or quality-of-life benefits in a trial. For example, one of the trials offered the potential to reduce the number of times I had to go for my routine treatments. Another one was a Phase IV trial in a broader population, which inherently constituted less safety risks. It also made administration easier, and freed up what had been hours of subcutaneous administration.
The secondary consideration, especially in Phase I-III trials, is if the sponsor can take steps to make participation less burdensome, as they tend to require more time commitment.
What actions have the sponsor implemented that’s made participation easier?
For the blood draws, I was given a choice to either go to the clinic or to have a mobile phlebotomist come to my house. I usually chose to go to the clinic, because I live in the area and I like to have interactions with the study team. But I also had the flexibility to switch to a mobile phlebotomist for any study timepoint/s if in-person visit to the clinic was not feasible.
Additionally, they coordinated my blood draws with my routine clinical blood draws, so I didn’t have to “get stuck” twice.
I also really appreciated that they did joint workshops previously seeking patient and healthcare provider perspectives. The workshop wasn’t about the trial. It was a broader view of what the industry could do for the patient community in order to bring forth solutions that are more impactful, in addition to providing new therapies.
"If I can understand the science, it is easier for me to get behind the idea of participation."
You’ve said no to participating in trials before. What made you say no?
It was a trial involving IP for “curative” intent. I was unable to get clear answers on a few questions regarding the trial, although I trusted my doctor and the care team to provide me optimal clinical care. My questions were not about the IP itself, but about the conditioning therapy and the options that would be available from the pharmaceutical company if the trial failed me, not only in the short term but also in the long term – if I was to have an adverse outcome decades later.
Another important thing to me is transparency. I want to know what the past results have been, what the mechanism of action is, and why you think that the drug will work for this patient population. If I can understand the science, it is easier for me to get behind the idea of participation.
How are you finding out about these trials?
Almost all of the trials were recommended to me through my care team. I’m not at a place where clinical trials are my only care option, so I usually don’t actively seek them out.
What is something about clinical trials that you would flag for sponsors?
I would like more results returned to the patients and the care team. For example, with the recent trial participation, I got some results back, but not all of them. I understand that most of that has to do with future research and may not apply to my clinical care at the time of participation. However, research is ever-evolving.
Even if it’s not significant enough for a clinical decision right now, it may prove to be important down the road. It’s my data and I should be able to have rights to it. For example, if they found a biomarker that eventually proves to show that a certain drug will be more or less efficacious, I want to have that information right now for when the science evolves to the point where it’s applicable.
"Sponsors have to take into account the life changes – where the patient may be at the start of the trial may be different from where they are a few years later, while the trial is still ongoing."
Is there anything else you want to tell sponsors?
It is important to plan clinical trials that accommodate patients’ lives. Most clinical trials are multi-year commitments. Sponsors have to take into account the life changes – where the patient may be at the start of the trial may be different from where they are a few years later, while the trial is still ongoing.
If we go back to the example of choosing between mobile phlebotomy and in-person blood draws at the clinic, I could change that option anytime during my participation. So, if I decide to move away from the clinic, I don’t have to drop out of the trial, fear non-compliance or make significant accommodations to continue to participate. Particularly if the industry wants to enroll more diverse patients – people of color, single parents, etc. – sponsors have to create opportunities for trial participation to fit their schedules, otherwise, they just won’t participate.
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