Listen and support: How to conduct a patient-centric clinical study
Clinical trial sponsors understand the value of patient-centric studies, but success relies on a time-consuming paradigm shift and progress is slow. Will greater partnership with patient organisations and utilising emerging technologies help the industry move from theory to practice?
Patient centricity is a hot topic, and the benefits of greater engagement have been demonstrated time and time again in recent years.
Turning the ship of the traditionally conservative industry, however, takes time, and examples of meaningful patient engagement in clinical trials are few and far between.
“Clinical studies are often seen as a research process that’s performed on patients rather than with patients,” says a new whitepaper from Manchester-based patient engagement agency, Couch.
“In many research processes, patients are regarded as a source of data – their personal preferences and goals aren’t being considered. As a result, the clinical study experience isn’t engaging and, often, isn’t all that relevant to the patient.”
This can lead to dropouts, failed clinical studies, and patient needs remaining unmet. But there is another way.
According to a 2018 Economist Intelligence Unit study, patient-centric studies took almost half the time to recruit participants and recruited double the number of patients.
What’s more, drugs developed during such trials were 19% more likely to be launched than those tested in traditional studies.
It means that building studies around patients could be “the difference between success and failure”, says the whitepaper, Clinical Study Success: Design with Patients, for Patients.
Real and perceived barriers
Despite such clear figures, many companies do not implement patient centric initiatives as standard. Lingering scepticism is one explanation for this, but Couch believe there are also operational factors at play.
There is a lack of clarity about its strategic importance, a lack of key performance indicators to show return on investment, and fear around non-compliance and adverse event reporting.
Importantly, many research teams simply do not know how to “do” patient centricity.
“In the Annual Patient Centricity Benchmark Survey, when asked about training or preparing people to behave in patient-focused ways, over half of employees from biopharmaceutical and medical device companies said: ‘We are actively looking for what and how to teach this to our people’.
“Only 22% selected: ‘We know exactly what and how to teach this to our people’,” says the whitepaper.
The key to designing a patient-centric product is meaningful engagement throughout the product development pathway – that starts at protocol design and continues right through to post-marketing, the paper explained.
“To be patient-centric is to listen to what your patient has to say – not just hear them, but to understand their needs and priorities, and incorporate this into your decision-making.
“We should never assume that we know what the patient wants,” say the authors.
There is only one way to ensure that new treatments address unmet need, and that is to ask patients what matters to them.
“Getting the patients involved to discuss the study design process helps to identify crucial questions and outcomes.
“For example, a previous study found that more than 75% of individuals with diabetes would prefer clinical studies to assess patient-reported outcomes, such as their quality of life, rather than surrogate variables like HbA1c.”
Working with patient advocacy groups (PAGs) is one way to ensure the patient voice is heard when designing a study, they add.
“PAGs play an important role in providing the right tools and resources for their patients and having patient advocates on your side means they’re more likely to spread the word about (the) study. But most importantly, (sponsors) and PAGs ultimately have the same goal – to improve patients’ lives.”
A new generation of clinical trial technology, from eConsent and electronic clinical outcomes assessment to recruitment and remote monitoring apps, has been designed with patient centricity in mind.
Taken together, they can provide 24/7 support and guidance right through the clinical study process, making patients feel more comfortable in their participation
As well as boosting retention and improving communication between subjects and research teams, this approach leads to better adherence, medical decisions and health outcomes.
“Using digital technology and medical apps to engage with patients is becoming increasingly popular. For example, eCOA is one of the fastest growing digital patient engagement tools used in clinical studies today.
“With a digital platform that’s compatible on multiple devices, key stakeholders can access the same integrated platform. It provides the knowledge and resources that patients, site staff and study teams need throughout the conduction of the study, allowing virtual guidance at all times.”
Patient centric trials are not difficult to execute, but companies will need to shift their thinking and processes if they are to embrace the opportunities they present.
“Listening to patients’ needs, from the very beginning all the way to the very end, will create relevant clinical studies, improving both recruitment and retention to maximise the chances of success for clinical studies,” concludes the whitepaper.