Why listening matters
Clinical trials are important – vitally so. They are the science that needs to get done to help make the world a healthier place. However, as vital as clinical trials are, there are major challenges that every study has to overcome in order to be successful. Even leaving aside the uncertainty of whether a drug hits its endpoints, simply finding people to participate can be quite difficult, and retaining them can be even harder, especially if their needs are not being met.
This is where inVibe’s exclusive voice response offering comes into play and where listening can be truly crucial to designing a trial that works. How can you best make participating in a trial more straightforward for patients? How does simply listening to the patient at all stages of a clinical trial impact recruitment and retention? How can you anticipate what parts of a trial process patients will find most burdensome? Simply ask a few, and listen to what they have to say. This process of Co-Creation can lead to trials that are truly patient-centric, reducing the common, yet burdensome challenges they face, and helping to bring the drug or treatment to market. The trick, of course, is knowing how to listen.
A case study
Recently inVibe worked with a mid-sized pharmaceutical company developing a treatment for Parkinson’s Disease. Our client wished to understand how participants react to and interpret the Informed Consent Form (ICF), particularly regarding the Study Purpose, Participant Responsibilities, and Potential Risks & Benefits. This is a valid concern – if a patient is not quite sure of what the goal of a trial is, what is expected of them, and what the potential upside and downsides to participating are, they are unlikely to enroll. The task was fairly straightforward: have Parkinson’s Disease patients and caregivers evaluate the ICF, understand what was confusing or potentially detrimental to future recruitment, and recommend potential solutions.
To accomplish this goal, inVibe leveraged our voice response methodology to listen both effectively and efficiently. To listen effectively, we created a set of eight automated voice prompts for patients and caregivers to respond to. This voice response design created a structure that allowed respondents to speak freely, while simultaneously setting boundaries on the topics being discussed. To listen efficiently, we fielded this study with 17 patients and 4 caregivers in 72 hours, then we got to work on analysis.
“I thought the document was very thorough, and it wasn't overburdening. So, in other words, I felt like I could read the entire thing without getting overloaded with information. But it was very clear. The risks were present. The amount of time it would consume was pretty evident.”
Overall, the responses were positive. Respondents were generally able to explain the purpose of the clinical trial in their own words, and they found the decentralized design of the trial more compelling and less burdensome than a more traditional trial would be. However, there were some important nuanced points that required further exploration.
First, some respondents were uncertain about whether they would be eligible for the trial. As anyone who has encountered this uncertainty in trial recruitment can attest, if a patient is not sure about whether attempting to enroll will be a waste of their time, they likely will not bother and self-select out of the process. We emphasized the need for absolute clarity on eligibility requirements to prevent potential harm to recruitment.
Second, we had some respondents raise the issue of how to manage any potential side effects of the trial drug. Again, this uncertainty can cause issues both with recruitment and with retention, as a patient encounters a problem, is unsure how to address it, and chooses to discontinue. Again, we proposed a straightforward solution: provide more information on AE management at the outset, as well as link to resources that participants can bookmark and refer back to when needed.
“I guess that the biggest potential risk and potential dealbreaker would be the spinal taps, of course. I understand that they are painful and risky, but you also have to consider that there are potential benefits like getting to know your disease better, and that should also be highlighted.”
Last, and perhaps most importantly, respondents flagged up the risks of treatment. Here the issue was slightly different; participants understood the risks, but not necessarily the reasoning behind them. For example, the trial would involve multiple lumbar punctures, which the informed consent explains clearly. However, the ‘why’ behind these punctures was left unexplained, which led respondents to call them out as a potential barrier to entry. While patients will implicitly understand that these sorts of procedures are part of the trial, we advocated for a ‘more is more’ approach to explaining the punctures as part of a diagnostic process and an evaluation of the treatment. A lumbar puncture is never going to be pleasant, but making sure that a patient knows precisely why it is happening and how it can help can make the prospect less discouraging. After listening to patients describe this discomfort, we recommended that the trial developer explain this procedure and the reasoning behind it as clearly as possible to get participants on board.
While patients implicitly understand that these sorts of procedures are part of the trial, inVibe advocated for a ‘more is more’ approach to explaining the punctures as part of a diagnostic process and an evaluation of the treatment. A lumbar puncture is never going to be pleasant, however making sure that a patient knows precisely why it is happening and how it can help can make the prospect less discouraging. After listening to respondents describe this discomfort, we recommended further explaining this procedure and the reasoning behind it as clearly as possible to get participants on board. What they needed to improve their odds of a successful trial was to listen, and at inVibe, that's what we do.