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Our series on patient centricity continues with a patient perspective on her interpretation of this subject. Shelly Hoover, an ALS patient, shares her views with Moe Alsumidaie.
We continue our series on patient centricity, and in this article, we are bringing in the patient’s perspective on the topic. Shelly Hoover, an ALS patient, shared her perspectives at PanAgora’s Patient Experience Summit, and in this article, will elaborate on her interpretation of patient centricity. PanAgora’s Mobile Health Summit will delve further into the use of digital health in clinical trial patient centricity.
1. What does clinical trial patient centricity mean to you?
Patient centricity means that clinical trials are designed in a way to attract, engage and retain patients through the duration of the trial. The patient should feel empowered, be an important part of the study development process, and be treated as a partner, not as a subject. From a patient perspective, it would be convenient to have study procedures done remotely or at home, but limiting all clinical contact wouldn't necessarily be a good thing since it is important to have some interaction with the investigator. My biggest frustration with lack of patient centricity is the lack of information provided by sponsors; we oftentimes don’t fully understand what we need to do in the study, and there isn’t much communication.
2. What challenges did you face when you participated in your last clinical trial?
The sponsor did not put themselves in the patient’s shoes; there were four separate week long hospital days out of town as a part of study participation. I wanted to give my husband, who is my primary caregiver, a break, so I didn't ask him to stay with me and I ended up being very lonely. It was frustrating because as an ALS patient, I cannot do enough things by myself and I felt like I was bothering the staff while they were attending to very ill patients. I also participated in another Phase II yearlong trial, and throughout the entire process, I received zero information about what was being measured. My part of the trial ended two years ago and until this day I still do not know if I had the placebo or the drug. I would be very hesitant to participate in something like that again. I felt completely out of the loop and uninformed about what was happening. I recognize that a lot of the information is confidential and that there are things that are not appropriate to share, but I am talking about the things that can be shared; I am conducting the procedures, and it is my medical data too.
3. What tools would be helpful in a clinical trial?
Let’s say that I am going in monthly and we are doing a blood draw, I would love it if an app or an artificial intelligence avatar was there to remind me of procedures, inform me of what needs to be done, tell me what was being measured, and show me the data that I’m providing to the sponsor. That would help keep me engaged in the process. I am almost 52, but in terms of technology and access to information, I am much more like a millennial. Some older patient population do not care because they do not know that you can share that kind of information. So, I cannot speak for all patients. But, certainly for me, having access to that information would be vital to keeping me engaged in the clinical trial.
4. A lot of biopharmaceutical companies are talking about patient centricity. Do you think they are on track with making studies more patient centric?
I am participating in a sample study since December 2014. I have to provide skin and blood samples and I wear an activity tracker one week a month, answer survey questions, do voice recordings and provide information monthly. I stay engaged because I have access to all the information being gathered. For example, my genome sequence can be accessed through logging into my private portal and tracking all my information. There are also quarterly webinars to keep us updated and answer questions. This truly is a patient centric trial. I know that patients were involved in the design of the trial, and the study team really knew that if they were going to keep patients engaged in the long haul, that this kind of sharing of information would be vital.
By brining me in the process and sharing information with me, I feel like I am a more valuable contributor because I can see that what I am doing is making a difference and that the data is valuable to the people who are gathering it. I feel affirmed, validated and useful in the process. Sometimes when you are dealing with a physical illness, you do not feel very useful, so it is a nice feeling to have when you are paid attention to and are a part of a greater cause.
5. How can biopharmaceutical companies make studies more patient centric?
First, include patients from the very beginning in your design process and obtain feedback on study procedures and devices, because something that may not appear as important to trial designers may be very important for the participant. For example, there was a study when I was wearing several activity trackers, which were those big red plastic devices, and I attached them to my wrists and ankles with Velcro and the Velcro always snags my clothes. So, if I were a part of this study during the trial design, I would ask the study team to not to make me wear Velcro because it destroys my clothes and was very uncomfortable. A research designer would think that this the economical way to use the tracker, but it’s the most frustrating and causes me the most noncompliance, because I don’t even want to wear it. Another thing sponsors should do is to provide patients with access to information that is permissible to share as soon as possible. You can share results of some blood tests, and an explanation of what you are measuring without compromising your trial. Give patients the option, as some people might be overwhelmed with that much data and others might be hungry for it.
6. As an ALS patient, what outcomes are important to you in novel therapy development?
We do not have a lot of biomarkers in ALS, so our outcomes measures are breathing capacity, the functional rating scale etc., which are all subjective. The range of “being able to do this versus not being able to do it” is so huge that it is a difficult measure. A great outcome to start with would be to stop the progression of the disease or significantly slow down the death of the motor neurons. It is a tough place for researchers, but we are looking for the treatment that will have some efficacy in slowing our disease progression.
For cases in which expanded access, or right to try programs apply, give patients open label access after their participation is complete. In ALS, patients cannot participate in clinical trials 24 to 36 months after initial symptom onset, and many die without even being able to volunteer in clinical research; not even Phase I studies. It is unconscionable to think that patients who are willing to be first patients for trying the drug in humans, are already dead long before the drug makes it through the FDA process. So, providing access to patients who participate in Phase I trials, to me, is the only humane and compassionate thing to do. If the trial truly is about the patient, there needs be a little more risk involved in allowing patients access to that medication.
Moe Alsumidaie, MBA, MSF is Chief Data Scientist at Annex Clinical, and Editorial Advisory Board member for and regular contributor to Applied Clinical Trials.