Patient-Centric Clinical Trials Europe 2015

Jun 8, 2015 - Jun 9, 2015, London

Put the patient at the heart of the clinical trial

Translating Patient Centricity into Organizational Reality

Positive patient experiences and patient outcomes with high recruitment, adherence and retention result from alignment of the HEART, HEAD and HANDS within the research sponsor’s organization and among all key stakeholders.



The clamor for greater patient centricity is something that can no longer be ignored in the clinical trials environment. Rising R&D costs – caused in large part by difficulties with enrollment – and a general lack of trust in the industry have combined with patients’ concerted demands that they should no longer be kept at arm’s length. Given these trends, the movement towards patient centricity in research is gathering momentum: pharma and healthcare organizations realize that they need to do something. 

But organizations are wary of what they see as regulatory and reputational minefields and want to know how they can navigate their way safely into this new territory. Many of the answers come in ”The Patient-Centered Clinical Trial: A New Paradigm”, a thought paper in which eyeforpharma has collaborated with veteran organization management consultant Joyce Avedisian. CROs, patient advocates and senior pharma executives all offer their thoughts on what the issues are and where the main problems lie: from early phases of development to post-market surveillance studies, pharma needs to engage better with patients and those closest to them - physician, family, caregivers, and advocates.

In September 2014, eyeforpharma brought together 100 senior clinical leaders to discuss the evolving nature of patients’ role in clinical trials. The paper is part of a series building on some of the key ideas that industry, patients and stakeholders expressed. Avedisian provides compelling arguments as to why pharma needs to grasp the nettle and highlights practical examples on how to institute the organizational changes necessary to make the truly patient-centered clinical trial (PCCT) a reality. It is a blueprint to make this into sustainable business practice and it needs to be seen.

The PPCT Concept: From the Inside Out

 

Putting patients at the center of clinical trials requires engagement on multiple levels within an organization, and between different partners. The whole process needs to be seen through a new lens, with the “heart, hands and head” of each sponsor and stakeholder aligned with one another in order to allow the best possible chance of a successful outcome. It all begins with the company culture: putting a patient-centered heart into the trials process requires competent, compassionate staff whose primary motivation is to serve the patient. Patient focus, above all, needs to be thought about as a way of feeling, believing, thinking and acting. This means that, in the clinical setting, patients must be treated as whole human beings rather than data subjects, with pharma, the site staff and all key stakeholders aligned on serving the patient first and foremost with a passion for caring. Taking its lead from the heart, the head then sets the vision of what success looks like, the values which will guide how everyone will act throughout the process, and on to nuts and bolts issues such as exactly what an engagement strategy is going to look like. Finally, the emphasis shifts from the head to the hands – the hands representing how things get done, from processes to methods, technology, programs, initiatives, information flow and behavior. In this new paradigm, the benefits of adopting a patient-centered approach are clear: Only now can positive patient experiences and outcomes with high recruitment, adherence and retention ensue.

Walking the Talk

Being serious about putting patients at the heart of your operations starts with listening closely to, and understanding, what they want and what they value: for example, why should they get involved in a trial in the first place? What obstacles need to be overcome? It is vital that patients’ views be taken into account at the trial design stage rather than some way down the track. Avedisian shows how a continuous flow of information and learning from patient advocates and patient partners is vital to inform planning, decision-making and problem-solving at every step of the value chain. The paper draws on a few best industry practices to summarize how the intertwined dimensions of engagement across heart, head and hands would work in an ideal scenario which takes the reader from design of the trial, through planning and recruitment, to actually carrying it out and beyond. It also lays out concrete steps for “Executive Action” which are aimed at facilitating or reinforcing patient centricity. Throughout, trust is the key: and companies must buy in to this because nothing will erode that trust more quickly than stakeholders who talk the talk but fail to walk the walk.

A Case Study-led Approach

Throughout the paper, Avedisian uses case examples to reinforce the core points of the PCCT, looking at ways in which companies have applied the approaches to real-world issues of engagement. Sanofi and Genzyme, for example, explain how they frequently test study designs with patient advocate groups and doctors to understand how the process could be made less burdensome for those taking part – by reducing the numbers of visits, improving data collection, and so on. Crucially, the companies are also trying to find out whether patients understand fully the commitment that is required of them, and that the trial will fit with their lifestyle. Meanwhile, the Patient-Centered Outcomes Institute (PCORI) has created an evaluation tool called WE-ENACT to build “the science of engagement”. It uses this tool in every project to assess engagement levels and identify barriers and, as a result, is starting to be able to measure the effect of patient involvement on the process and outcomes. And PMG Research has seen, in a partnership with Wilmington Healthcare, efficiency increases, cost savings and improved satisfaction from physicians and, vitally, patients. The paper contains many other practical instances, including in the burgeoning area of cancer research, where organizations are attempting to pave the way – in some cases through innovative use of social media - for true collaboration between patients, pharma and healthcare.

The Way Ahead

Senior leadership teams must elevate patient experience – as well as safety and efficacy – to prime importance in the trial setting. Setting clear direction and aligning key stakeholders around a shared vision will help to achieve this. The underlying premise of eyeforpharma’s thought paper is that putting this paradigm into practice builds trust based on caring and competence. This trust fosters authentic engagement and alignment of all key stakeholders, yielding positive patient experience and outcomes – which in turn improves recruitment, retention and adherence in clinical trials. In short, it is a win-win situation – but only if the values, preferences and needs of patients are allowed to influence the design and conduct of trials, as well as the dissemination of results. And above all, everyone involved must always be asking themselves one key question: “Is what I am doing in the best interests of the patient?” Problems are defined and solutions identified by listening closely to the patient and acting on what they say. Pharma faces many challenges at the moment, but by adopting this new mindset it can begin to overcome some of them.


Like to learn more about the PCCT concept? Make sure to access your copy of eyeforpharma’s industry leading white paper here.


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Patient-Centric Clinical Trials Europe 2015

Jun 8, 2015 - Jun 9, 2015, London

Put the patient at the heart of the clinical trial

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