In September we published a state-of the-industry report on the perceptions, practices and future expectations of patient-centricity in clinical trials in 2017. The report reveals insights based on a survey of our global database of clinical trial professionals from CROs, pharma, service providers, academia and patient groups split across North America, Europe and Asia.
We've asked six leading experts to give their views on the report and more generally on the state of patient-centricity in clinical trials today.
Nancy Meyerson-Hess - Associate Partner, admedicum Business for Patients, and previously Head of Clinical Operations & Compliance, Grunenthal
“The survey illustrates what many of us are thinking: yes, the industry says that patient-centricity in clinical trials is important, but that most are not actively implementing this. Part of the reason is the definition and scope of what is patient-centricity.
As we embrace technology, we will be balancing aspects of confidentiality, such as in patient recruitment and the consenting processes. Although the paper did not focus on regulations, this will definitely be a direction driver for how we all implement patient-centricity in the future.”
Claire Nolan - Research Involvement Manager, Parkinsons UK
“Collaborative working between people affected by health conditions and companies developing treatments is the future of health research so it’s encouraging to see that the vast majority of respondents recognise that patient centricity must be embraced by companies.
From a patient organisation perspective, I’d like to understand a little more about companies using patient advocacy groups to solicit patient input. My feeling is that some companies may consider patient advocacy group input and patient input as one and the same, which it is not.
The differences between Europe and North America are interesting, although unsurprising. Similarly, the contrast between companies and CROs is predictable, but I’d like to see CROs become more proactive and creative in ensuring the patient voice is represented throughout their programmes. This is something we’re looking at more closely as an organisation supporting industry to become more patient focused. For both CROs and companies my belief is that truly embracing patient-centricity is the key to a competitive edge.”
Dr Stephen Nabarro - Head of Clinical Operations and Data Management, Cancer Research UK Centre for Drug Development
"It is refreshing to see in the report that 77% of respondents view it as extremely or very important that their company embraces patient-centricity, but we feel that one battle the industry faces is the question ‘what does a truly patient-centric trial look like?’. Is it a trial where interventions and medications are delivered at the patient’s convenience after work? Where the visit schedule has been truly optimised to ensure minimal time and invasiveness to patients? Where nurses and doctors visit patients at home rather see them in hospital?
If this is the case how can we implement this for early phase trials of novel IMPs that we deliver at CRUK's Centre for Drug Development? How can health services across Europe and America adapt to deliver trials in this way? Will the cost implications of delivering trials like this deliver adequate ROI to the Sponsor?
Continued technological advances in clinical trials will inevitably make trials more patient-centric, but will also require more consultation with patients up front to ensure the technology is patient-friendly. However, for certain populations, does using technology actually make a trial less patient-centric? Does it exclude patients from participating? How can Sponsors get this balance right?"
Jessica Morris - Co-founder, OurBrainBank and SVP and Partner, FleishmanHillard
“The report highlights the very real and present danger that patient-centricity is seen by too many as a buzzword. This ignores the reality of the way in which the digital revolution is disrupting all areas of life, including healthcare. We are moving from a world where patients are the passive recipients of expert care from medical deities, to one where the patient is at the centre, co-collaborating with medical experts.
Our new literal limbs – our smart-phones and wearable devices – are key drivers of this shift. Without asking, I know how far I’ve walked each day. More measures will follow soon. We will all be more aware of our health, better able to understand and manage it, and therefore more able to understand our bodies and our symptoms.
The digital revolution both enables patients to better manage their health, while simultaneously empowering them to seek faster and more efficient treatments. Patient-centricity is therefore not a choice, but a growing reality. It’s here to stay, and those who choose to surf the wave of digital-driven innovation will reap the benefits.”
Marleen Kaatee - Founding President, PSC Patients Europe
“It’s shocking to see from the report that 29% don’t solicit input from patients in any way, shape or form. There are a lot of well-trained patient advocates out there, such as Eupati Fellows and Eurordis Summer School alumni, who can contribute to clinical trial development that would be beneficial to organisations and studies.
Patient-centricity can only succeed if all stakeholders grasp the concept correctly and act accordingly. There is a necessity not only to have consensus about the terminology, but also to have each stakeholder’s organisation embed the concept throughout, top-down and bottom-up.
ISPOR is working on a project collecting the terminology used around patient-centricity online and in literature and have extracted 187 different definitions! They are currently narrowing down on an ISPOR standard term & definition.
One approach could be an inventory of the common ground, for both pharma and patients, and work from there. What better way than to develop patient-reported outcome measures in collaboration with the proper patient representatives?
While you’re at it, don’t forget to involve patients in other areas such as trial design. Knowing up front the willingness of the patient community to participate in trials, especially if there are potentially invasive procedures for the outcome measures, can save a lot of effort, time and money!
Therefore, the steps to a patient-centric study are:
1. Embrace the concept organisation-wide.
2. Make it work to your benefit, and to all the other stakeholders.
3. Seek the opportunity to enrich your trial design and enhance your patient recruitment in clinical trials.”
Dr Julie Vallortigara - Research Officer, Ataxia UK
“The responses to how patient-centric initiatives should be driven are very interesting. The fact that initiatives coming from both patient and clinician are seen as being the most appropriate is a good indication to take into account when moving things forward. At Ataxia UK, we are working with both patients and clinicians, and we strongly believe in this approach. We have specialist clinics that act as Centres of Excellence where patients with ataxia receive appropriate treatment and care, and where everything is also in place to run trials, including an experienced clinical team and a cohort of patients to recruit from.
Choosing such sites for a clinical study where patients and clinicians know each other and can work together, will certainly help with patient engagement, retention, adapted outcome measures and overall a positive experience for patients taking part in the trial.”