Go directly to the source—Patients
With more companies working on patient-centric initiatives, it’s a good time to appraise what is being done to enhance the patient’s clinical trial experience. Although there is no agreed-upon definition of the term patient centricity, the premise is to put patients first.
The National Institutes of Health (NIH) has defined patient-centered care as “healthcare that establishes a partnership among practitioners, patients and their families (when appropriate) to ensure that decisions respect patients’ wants, needs and preferences and solicit patients’ input on the education and support they need to make decisions.” Eyeforpharma defines patient centricity as “the process of designing a service or solution around the patient.” Regardless of how patient centricity is defined, it involves obtaining patient and/or caregiver input. Patient perception of clinical trials is important, and clinical trial sponsors have realized that in order to be successful, they need to have engaged patients.
With patient-centricity initiatives blossoming, it begs the question—have we previously been operating without considering the patient? The honest answer may be surprising. If the entire reason clinical trials are conducted is to bring medicines to patients, is it possible that patient opinion has been largely left out? There are multiple reasons that may have prevented patient centricity in the past, including the loss of control, lack of budget, perceived regulatory bias and the elephant which is present in many rooms—the lack of buy-in on the importance of asking patients what they think.
Why should patients be included in the process? What can they tell us that will help those involved in clinical research be more successful? For starters, we need to realize that, over time, the clinical trials being developed are becoming more complex. According to Tufts CSDD, the number of scientific endpoints in a phase III study have almost doubled the last five years and the average number of visits and the total number of endpoints have increased. With the added complexity, recruitment is positioned to suffer. More visits, longer visits and unnecessary “non-core” procedures make trials less appealing to patients. I had an opportunity to listen to a patient involved in a clinical trial recently who expressed that, when a study is so complex that it is difficult for a site to follow, confidence from the patient perspective is negatively affected.
Patient panels are a way that clinical trial sponsors are gathering patient opinions on studies. These are essentially focus groups that provide valuable information. The type of information that can be collected is dependent on how far along the study is. If the protocol is not yet developed, a patient panel can provide feedback to be used to design a trial with patient preferences in mind. Information about motivation to participate, recommendations on reducing the number of visits or allowing home visits, and feedback on the technology planned for the study can be collected and included in the protocol. Once the protocol is finalized, there is a limit to the changes that can be made, but it’s still possible to get input on patient pain points and devise plans to overcome them operationally. For example, if getting to the site is an issue, but the protocol is final and does not allow home visits, adding a car service may be a beneficial operational solution. Additionally, patient panels can be used during post-protocol finalization to gauge the effectiveness of patient-facing study materials, including recruitment images, the content of messaging and suggestions on how to best disseminate the information.
How many companies are embarking on patient-centric initiatives? According to the 2015 Clinical Trials Transformation Initiative (CTTI) Survey of 95 pharma/biotech/device companies, 61% of the 95 companies surveyed have either established a patient-centric initiative or are planning one. One of the benefits of engaging with patients is the transparency it provides. Patients value open communication and learning about the experiences of other patients. Authentically empowering patients by listening to and honoring their recommendations can enhance the sponsor/site/patient relationship. Patients want to be asked, they want to be included and they want their voices to be heard. Market research has been relied on heavily to aid industry in learning about patient preferences regarding certain clinical trial aspects, but going directly to the source can provide invaluable information. Listening to patients, sharing ideas and respecting their wants and needs builds credibility for clinical research.
Ashley Tointon has more than 18 years of patient recruitment and project management experience supporting clinical trials and the pharmaceutical industry. Currently she provides recruitment expertise, strategy and leadership as Principal Consultant of Accelerate Clinical Enrollment LLC. Email firstname.lastname@example.org or tweet @AshleyTointon.
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