Can clinical trials ever be patient-centred?
Patient centricity is no longer just viewed as an opportunity solely for commercial pharma. In September 2014, I brought together clinical leaders to discuss the evolving role of patients in clinical trials. The executive forum addressed the latest trends and innovations in clinical trial management from a patient-centric perspective, but it was the presence and involvement of several patients and patient advocates that shaped the discussion and expanded my thinking on the topic.
Beyond debating various practical questions, we began to wonder how the necessary changes might materialize under the organizational lens:
“What if clinical trials consistently led to positive patient experiences and patient outcomes with high recruitment, adherence, and retention?
“What would the trial – and the processes that support the trial – look like?”
These two questions beg the answer to a third question, “What have we learned about how to effectively implement patient-centered clinical trials?”
Obvious catalysts for developing answers to these questions are escalating R&D costs, low levels of patient trust in pharma coupled with a growing societal demand of greater patient empowerment. In a recent survey of patient groups conducted by PatientView, pharmaceutical innovator companies ranked 7th out of 8 healthcare sectors, with a minority of 34% giving pharma a “good” or “excellent” reputation rating.
Beyond those circles of already engaged patients, polls on a broader societal level consistently show that the image of the pharmaceutical industry is weak, if not clearly negative in many key markets, including the U.S., Canada, China, Germany, and Spain, as data from Ipsos’ Global Reputation Centre shows. Such distrust is also likely to contribute to poor patient recruitment and retention, one of the greatest challenges the clinical enterprise faces today. Less than 10% of clinical studies are completed on time. These delays are inflating budgets to a severe level as enrollment costs account for up to 40% of total US clinical research budgets.
Given those trends, the movement towards patient centricity in research is gathering momentum within pharma and healthcare organizations. In discussions with executives from manufacturers, CROs, providers and patient advocate organizations, you usually discover divergent understandings of patient centricity.
Based on numerous conversations with practitioners in the field, I have no doubt that it must be a process integrated throughout the entire pharmaceutical continuum or value chain, from early phases of development to post-market surveillance studies. For genuine engagement, the values, preferences, and needs of patients must influence the design and conduct of clinical trials, as well as the dissemination of trial results.
Respect for patient needs requires building a trusting and collaborative relationship with patients as well as those closest to them, such as their physician, family, caregivers, and advocates. To drive this notion further, I collaborated with Joyce Avedisian, a veteran expert in helping complex organizations adjust their thinking, to develop a paradigm which enables all those serving patients to be guided by a new mindset.
In what was originally planned as a series of articles, but turned into a great piece of its own, Joyce came up with a unique perspective: A lens that engages our hearts, heads, and hands. She defines and gives practical examples of each dimension, and how they work together in practice. The underlying premise is that implementing this paradigm builds trust, which is based on caring and competence.
Trust fosters authentic engagement and alignment of all key stakeholders, yielding positive patient experience and outcomes. In turn, positive patient experience and outcomes improve recruitment, retention, and adherence in clinical trials. The ultimate objective: When the heart, head, and hands are in alignment and in play, patient-centered clinical trials have become sustainable business practice. That said, we really are only at the beginning of a long, bumpy journey. Some leading sponsors like Sanofi, Pfizer, Shire, UCB now have senior-level executives in charge of delivering on the promise pharma made to the patient. But, as an industry colleague so succinctly put it to me:
Patient centricity is not doing the same non-patient-centric things but with the addition of a graphic from management containing a bunch of call-out boxes emanating from a diagram of a patient in the middle. I see a lot of these slides but not a lot of action here with the exception of trying to be more creative in recruitment and retention and calling that ‘patient-centric’.
Change has to come from within. I believe we need exemplary organizational scenarios of the patient-centered clinical trial – the PCCT –, best-practices on creating the cross-functional operational team that supports it, and how clinical leaders can drive the needed change through executive action across divisions.
For sure, the time has come to adjust the pharmaceutical organization to become more patient-centered in the most meaningful way possible. Let’s begin the move from theory to implementation of the PCCT.
To explore the concept further, download the excellent thought paper here.