Michael Keens

	Patient centricity is both everything and nothing. Branded buzzword and marketing verbiage for some and for others a transformational impetus designed to lead to the rebirth of the clinical trial industry. The truth, as always, is somewhere in between. This article examines the advent of patient centricity, common misconceptions and traps related to its implementation, and offers tangible steps for Sponsors to integrate and improve their ability to achieve patient centricity within drug development.   

	For years the phrase “patient centricity” has been infiltrating the lexicon of the clinical research space, following quickly on the heels of its rise to prominence in hospital-based care, where more engaged and informed patients have been found to have fewer problems

 following everything from surgery to emergency room visits

	Within the drug development industry today, it is nearly impossible to avoid mention of patient centricity. The topic has overtaken conference keynotes and sessions, appears faithfully in industry publications, and is often a documented goal for sponsors and CROs alike.

	While the industry is significantly citing patient centricity, only a few seem to be taking real, impactful action when it comes to implementing patient-centric clinical trials. Patient-centricity shouldn’t be treated as a box to be checked off in a static, one-time act. So, what is it and what should it be?

	The creation of a more well-informed patient 

	Though the science behind drug development and clinical trials has rapidly increased in complexity, it’s the digital age that has catalyzed patient centricity.  Easy access to credible medical information has reduced or removed many of the barriers previously separating pharmaceutical companies, physicians and patients.  Physicians and pharmaceutical companies no longer have exclusive access to information regarding illnesses, diseases, and medical conditions, enabling even those patients with the highest respect for their physicians to undertake their own layman’s research, supplementing physician-provided information. 

	Patient expectations have changed as a result. With the advent of enhanced point-of-location services (i.e., Amazon delivery vs. traveling to shopping malls) and consumer-direct measurement of health (ie., FitBit and Apple Watch health metrics), patients expect to be active participants in their health care and expect participation in clinical trials to be less transactional and more partnership oriented.

	To understand how best to move from a transactional approach to one of partnership, we need to define exactly what patient centricity means in clinical trials. If you were to look at a formal definition it might read:

	The art of delivering a positive and meaningful study experience to today's informed, engaged, and connected patients through the application of a thoughtful, innovative, and technologically advanced and sustained suite of services.

	But dissect that definition and you’re left with a much simpler answer: Patient centricity, in short, is about reducing the patient burden.  While this seems easy, many in the drug development industry have inadvertently fallen into avoidable traps resulting in a “high-talk to low-action” ratio.  Let’s examine several of these implementation traps.  

	Overengineering and Underdelivering Patient Centricity – Avoiding Traps

	If the answer is that simple, why aren’t more clinical trials patient-centric? Why do many companies continue doing the same things in the same way they’ve been doing for decades? There are essentially three traps Sponsors and CROs have fallen into:

1. The minimalist trap – aka “the singular feel good action”

	The Minimalist Trap is essentially equating a small (and often one-time) step with true patient centricity. For example, talking to a patient (or patient panel) about their disease/condition once when drafting a protocol. Or the incorporation of ride sharing options (e.g., Uber or Lyft) to transport patients between site visits. While both are improvements compared to previous clinical trials, a one-time pre-protocol panel or merely changing the driver of a car but still requiring all visits to take place in-person, aren’t true patient centricity. Rather, both are examples of a singular, static “box checking” approach.

	Minimalist actions might be better than the historic status quo, but they provide limited enhancement or reduced burdens for most patients. Additionally, marketing such a small singular action may generate a mild amount of goodwill and provide some tangible activity that can be pointed to by Sponsors, but attributing this singular action as patient centricity has unfortunately bred a certain level of cynicism to the phrase within the drug development industry and patient community.

2. The aspirational innovation trap – aka “seeking utopia”

	Given the constant evolution of science and technology, there are many advanced, expensive, and difficult-to-implement approaches being considered within “Patient Innovation” hubs. Most of these ideas seek to dramatically change the approach to data collection or patient engagement, usually in a novel, technologically advanced, or grand utopian way that, unfortunately, won’t be feasible or operational for years to come.

	Innovation is critical to advancing the clinical trial industry but does little if anything to reduce the patient burden immediately. Without a practical path for integrating and operationalizing the concepts, sponsors and CROs are left with a gap they are unable to span and an inability to incorporate any real advancements or improvements into their clinical trials.

3. The short-sighted trap – aka “penny-wise and pound foolish”

	Cost is an important and significant consideration for sponsors assessing return on investment (ROI) within all clinical trial tools and services, and patient centricity is no exception. 

	However, given the paucity of longitudinal data or the application of patient-centric approaches after trial initiation, quantifying and reliably assessing such ROI on patient-centric investments has been difficult for Sponsors. And examining ROI efforts through a narrow perspective doesn’t work. Up-front costs are often slightly increased with a patient-centric approach, but recruitment and retention results are much higher. Patient-centric ROI, then, needs to be assessed more broadly to capture overall trial benefits. 

	Regardless of how you examine it, a few truths remain: 

		50% of sites are unable to enroll more than a single patient and 85% of clinical trials fail to retain enough patients to continue

		Those incorporating and supporting patient engagement have a 20% higher rate of drug approval in Phase 3 trials

	It is critical the long-term benefits of a patient-centric approach are included in any cost accounting and proactive trial planning and that patient-centric organizations provide data and information to Sponsors to support the value of the investment. 

	Innovation is important but shouldn’t be the only avenue we explore as an industry when there is a collection of solutions that have proven to be effective and efficient support for patients and can be implemented immediately. Likewise, while considering the expense of a patient-centric clinical trial is important, it shouldn’t prohibit sponsors and CROs from implementing cost-efficient and effective approaches. So how do Sponsors avoid the common traps above and benefit from the successful integration of patient centric approaches in their clinical trials?  

	4 Elements of a Patient-centric Clinical Trial

	Change isn’t easy. But creating a patient-centric clinical trial doesn’t have to be overly complex or expensive. Here are four approaches Sponsors, CROs and sites can do right now to make a clinical trial more patient-centric.

	Patient advisory boards are the most common “first step” on the path to integrating patient centricity and patients (or a proxy advocacy group) the opportunity to review the protocol before finalization. Most Sponsor companies are familiar with this step, which is good but integrating the patient advisory board into trials is less common. Sponsors can advance a more involved approach by fully examining how much the patient advisory board is included in establishing a patient-centric protocol, and balance that against budget and corporate comfort level.

	As Jessica Riviere, Senior Director, Global Patient Advocacy noted at DIA, “Does your company have the appetite, resources, and support to really do patient engagement? Your company needs to baseline their appetite for investment in patient engagement before stating ‘we’re patient centric’.” Examining this team and corporate comfort level when considering a Patient Advisory Board as a singular step or the platform for additional engagement is a true success factor to downstream understanding and clarity.

	Communicate to patients the efforts being undertaken and solicit feedback from patients and sites continuously during creation and implementation of the protocol process itself.  While many Sponsor companies undertake item #1 above and involve patients within the protocol drafting process, almost none inform trial participants of the efforts already undertaken to include the patient perspective. This lack of communication, and worse, lack of continuous engagement, often results in Sponsors falling into the Minimalist Trap listed above. 

	Creating an avenue for communication and continuous feedback enables ongoing dialogue and interaction at the site and patient level to increase awareness of trial items through the trial lifecycle. Establishing and nurturing this ongoing feedback allows more rapid response to feedback, increases trial efficiency, and demonstrates a higher degree of overall trial engagement.

3. Examine everything against your endpoints

	Protocols are growing more complex by the minute. Advances in science, including greater diagnostic and biomarker abilities, have made the inclusion of new research additive and further exploratory rather than streamlined. To prevent overburdening patients with tests, visits, and procedures, Sponsors should ensure anything included within the protocol and requested of the patient--a sample, a visit, a process--is tied directly to the primary or secondary endpoint. If it’s not helping answer a scientific question, it’s inclusion should be seriously reconsidered or, at the very least, strongly discussed and justified.  

	Outside of the patients themselves, patient advocacy groups are the most committed to the value of patient centricity.Engage with them early and often, and recognize the experience, enthusiasm, and support they bring to the patients you’re seeking to serve with your clinical trial. Outside of a medical perspective, Advocacy organizations know these patients better than the Sponsor. As Jessica Riviere noted in a session at DIA, “you can’t learn and read about advocacy, you need to have direct experience and exposure to build that knowledge and skill set.” 

	Many Sponsor organizations have existing relationships with Advocacy organizations, but often only within their Commercial departments and not within Research & Development. R&D team members should explore any internal connections with the advocacy community as a first step to establishing similar relationships and involvement to enhance their R&D efforts and patient support.

	The idea of patient centricity isn’t a fad and it’s not going away. If anything, the drug development industry, and more importantly patients, have come to expect integration and continued enhancement of the patient perspective within drug development. The challenge to the industry now is to better respond to meet these increasing expectations and better serve the needs of our patients. They are, after all, the sole reason clinical trials exist, and we are responsible for serving them as they participate in the drug development process. To do so would not only benefit trial patients, but the overall health system as well.

		https://news.gallup.com/businessjournal/183317/benefits-pre-surgery-education.aspx	

		https://www.ncbi.nlm.nih.gov/pubmed/25479173	

		https://www.bu.edu/fammed/projectred/publications/news/krames_dec_final.pdf	

		http://vertassets.blob.core.windows.net/download/64c39d7e/64c39d7e-c643-457b-aec2-9ff7b65b3ad2/rdprecruitmentwhitepaper.pdf	

		https://druginnovation.eiu.com/patient-centric-trials/ 

Articles

Michael Keens, COO of Firma Clinical, explores the beginning of patient centricity, common misconceptions related to its implementation, and offers steps to improve the ability to achieve patient centricity within drug development.   

Michael Keens

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