Clinical trials: making patient centricity the norm
Patient centricity should be at the core of clinical trials – but how do we get to the point where this becomes the norm rather than the exception?
“We’re at a tipping point in the design and execution of clinical trials, with patients as key stakeholders in this change,” delegates at a panel session of the recent Partnerships in Clinical Trials Europe conference heard.
Patient centricity is a much-used – some may say over-used – term. Yet for all the talk of placing patient centricity at the core of clinical trials, is this really the case in practice?
Certainly, from industry’s perspective, 60% of those pharmaceutical and clinical research organisations (CROs) interviewed for a US survey conducted by The Avoca Group1 rated themselves highly when asked how well they had worked in the past year to incorporate patient-centric thinking in the design and execution of clinical trials.
But, in stark contrast, 60% of the patients included in the research provided low-to-middling scores for the question and statements: ‘Do pharma companies care about patients as people?’, ‘Pharmaceutical companies carefully monitor the wellbeing of patients’, and ‘Pharmaceutical companies report on study data in an honest and unbiased way’.
Clearly industry thinks it’s doing well, but patients have a very different point of view. So how should pharma and CROs adapt to become truly patient centric?
“If you want advice on qualitative studies or need a statistician, you would invite their expertise into the design of the trial protocol,” said one member of the panel, chaired by Patty Leuchten, president and chief executive of The Avoca Group. “So why on earth would you not have a patient around the table and create an environment where they can ask questions, feel listened to and confident in posing their suggestions and ideas?”
“From a credibility perspective, there is a huge gap,” the panel noted. “Pharma and CROs need to ask the right questions and be prepared to listen to the answers. This, in turn, will result in positive benefits for patient recruitment, retention and cost-efficiency – and, ultimately, help improve the image of clinical research and the industry overall.”
Central to this ambition is ensuring patient information is both accessible and engaging. “Patient information is too long, too technical – you need a PhD to understand it – yet this is the basis of informed consent,” stressed panel member Kieran Doran, healthcare ethics lecturer, University College Cork, Ireland, who believes instead that informed consent should satisfy a four-pronged test to determine whether a patient can understand, retain, comprehend and communicate decisions in regard to their participation in research.
“At this point in time, informed consent documentation is self-defeating,” Doran added, because it acts as a barrier to recruitment into clinical trials. The industry is holding patients at arm’s length, rather than incorporating their insight into the decision-making process.
On top of this, the industry isn’t doing a good job in explaining what research is and giving confidence in clinical trials, the panel noted. “We need to shift the concept of clinical trials as a last resort and make sure research becomes the norm rather than the exception.”
In order to do this, we need to understand, and talk the language of, patients – not use the voice of industry, they stressed. As one patient pointed out in this survey, a good start is to care about patients as people, not call them subjects.
However, as the Avoca study demonstrates, giving the right information at the right time means those patients who have participated in clinical trials are generally more confident in the honesty and completeness of information given.
The industry needs to build an infrastructure that’s attractive for both patients and caregivers, the panel concluded. By recognising the value that patients bring, confidence in the industry and medical profession as a whole is likely to rise – and ensure the patient voice is heard in the design and execution of clinical trial protocols of the future.
- Patient Opinions on the Pharma Industry, Physicians and Clinical Trials. A research report by the Avoca Quality Consortium.
About the author:
Claire Bowie is Head of Publishing at pharmaphorum. She has extensive experience in healthcare communications and publishing, supported by a background in biological sciences.