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There is a lot of discussion and awareness on the topic of patient centricity, as many experts are starting to discuss how the concept can improve clinical trials.
There is a lot of discussion and awareness on the topic of patient centricity, as many experts are starting to discuss how the concept can improve clinical trials. Some experts indicate that patient centricity involves improving medication adherence, others argue that patient centricity is all about patient engagement, while a few suggest that patient centricity is about listening to patients’ needs, and evaluating patient reported outcomes not only in clinical research, but also in post-marketing environments. Eli Lilly even introduced an innovative study design platform that supports the concept of patient centricity.
The most concrete definition for patient centricity that I have seen is, “a dynamic process through which the patient regulates the flow of information to and from him/her via multiple pathways to exercise choice that is consistent with his/her preferences, values and beliefs. This fundamentally transformative concept affects how healthcare decisions are made and who has the authority to make them.”1 Nobody here is right or wrong! Patient centricity is ultimately interpreted by the eye of the beholder, but, how can we better focus on involving the patient in the drug development process? This article will offer a few insights about changing trends in patient centricity.
Much of this discussion is stemming from changes in insurance, industry and the FDA. For example, in a recent address by FDA Commissioner Margaret Hamburg, Hamburg indicated that the FDA launched a new initiative called Patient Focused Drug Development, where the FDA engages patients and biopharmaceutical sponsors to design clinical trials in collaboration with patients. For example, the FDA implemented a master lung protocol in this model and it yielded successful outcomes.
Patient centricity is also stemming from the insurance industry, which is starting to require feedback from patients and advocacy groups via patient reported outcomes research in order to make a determination for formulary coverage. To elaborate, Sam Waksal, CEO of Kadmon, a New York based biopharmaceutical company, indicated in speech that unless biopharmaceutical enterprises provide real metrics to payers and make patients, payers and physicians feel that a medical product offers value, payers will not reimburse for the medical product.
When a patient is feeling ill, the first thing they do is search on the internet to self-diagnose themselves, engage with other patients in online social forums (most likely around specific disease topics), ask their personal trainer, and seek homeopathic therapies to address their problems.1 Today’s patients are more informed, and are working with their physicians to find several treatment options for their ailments.1 Patients want to be involved in the course of their own treatment, and allowing patients to contribute towards the clinical trial development and execution process enables them to feel empowered, and keeps them engaged throughout a clinical trial, which can reduce subject attrition, and improve compliance.
Today’s patients are shifting their clinical trial search efforts to online and social media formats, as 46% of patients reported that they found clinical trials online.2 Moreover, many patients are going mobile, as smartphone adoption is becoming widely available to patients of all ages. Biopharmaceutical sponsors should consider leveraging these channels to reach out to and engage patients prior to and throughout a clinical trial. Mobile Text Messaging, for instance, is proven to improve outcomes in healthcare settings, such as ameliorating medication adherence,4 enhancing medical visit compliance,5 and boosting subject enrollment. Gamification is also an increasing trend in clinical trials, as such applications help patients better gauge their progress throughout a clinical trial, which can also reduce attrition and improve compliance. A more traditional format for patient engagement includes simply asking them; during a trial, interview the patients, request feedback via surveys, and amend studies based on patient feedback.
Similar to the introduction of risk-based monitoring, the interpretation of patient centricity is still quite vague, and will likely change as the industry explores this area. Nonetheless, it is critical to keep the patient’s perspective in mind; to patients, patient centricity is a matter of involvement. Patients are interested in contributing towards the cause of medical research, and they want to feel that the biopharmaceutical sponsor is present prior to, throughout and after a clinical trial.