Journal article
Preventing patient centricity from becoming a fad: this three-step process can help managers accurately assess how patient-centric their trials really are
Applied clinical trials, Vol.25(2-3), pp.14-19
01 Feb 2016
Abstract
Patient centricity is a popular trend with the potential to revolutionize clinical trials. By shifting from a product-focus to a patient-focus, clinical trials will become more relevant, less costly, and more impactful.1 Patient centricity has the potential to be "biopharma's Holy Grail" that will lead to a "renaissance" in clinical research.2,3
In order to allow patient centricity to reach its full potential and prevent it from becoming a fad, we must begin to scientifically measure its level of application in our clinical trials. Scientific measures will not only help us to understand the patient centricity of our trials, but will also provide a scientific basis for improving its role and clinical trials overall. Once we can measure the patient centricity of each trial, we can begin to understand how management interventions affect patient centricity levels, and provide a scientific foundation on which patient centricity can continue to develop and grow. But this vision all depends on a valid and reliable measurement. Preventing patient centricity from becoming a fad all boils down to scientific measurement of its ultimate impact.
Patient centricity in a clinical trial means designing and conducting a study-including the care of patients within the trial-in way that is respectful of and responsive to patient preferences, needs, and values, and ensuring that patient values guide all decisions within the trial.9 We recognize three important implications in this definition. First, patient centricity measurement is a component of clinical trial quality. Clinical trial quality refers to the overall excellence or superiority of the trial. We have previously defined quality and discussed at length in a previous article, "The Quality of Clinical Trials."10 Responding to patients is an important aspect of clinical trial quality.10,11,12 One can't understand the quality of a clinical trial without measuring patient centricity, as shown in Figure 1 (see facing page).
Patients have to do their part in order for a trial to be considered patient-centric. The degree to which patients are able, willing, and motivated to do their part in a clinical trial is called patient activation.14 The first part of patient activation is a self-assessment completed by the study participant. The Patient Activation Scale is a valid and reliable instrument to assess patients' perceptions of their own activation levels (see Table 4 on page 18). The scale breaks out into four different dimensions: believes role is important, confidence and knowledge to take action, taking action, and staying the course under stress.14 The "believes-role-is-important" dimension assesses whether the patient recognizes that they have a role. The "confidence-and-knowledge-to-take-action dimension" measures how able the patient is at taking the initial actions in following the protocol and caring for their health condition. The "taking-action" dimension shifts the perspective from potential ability to the patients' ability to execute the plan. But patients must also be able to persevere with executing their plan, which is measured by the "staying-the-course-understress" section.
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Details
- Title
- Preventing patient centricity from becoming a fad: this three-step process can help managers accurately assess how patient-centric their trials really are
- Creators
- Michael J Howley Jr - Drexel University, MarketingPeter Malamis
- Publication Details
- Applied clinical trials, Vol.25(2-3), pp.14-19
- Publisher
- UBM LLC
- Number of pages
- 6
- Resource Type
- Journal article
- Language
- English
- Academic Unit
- Marketing
- Identifiers
- 991021899413904721