A trial is nothing without a patient – Conversis’ Patient Centricity series

Patient centricity is very much the watchword of the Clinical Research sector at the moment.

It’s a topic we’re encountering again and again – at all this year’s major conferences, in conversations with clients, and amongst our colleagues and peers. And anything that’s this important to the sector is of crucial importance to Conversis. Patient centricity is at the core of everything innovative happening in the industry right now. It’s also a fundamentally meaningful approach to clinical research, which is being promoted by the relevant authorities, and in which translation has a significant role to play.

For all these reasons, we have decided to dedicate some time to our own discussion of patient centricity, with a mini-series of insights. This first of 3 articles will dive into the concept and its meaning, and look at how to go about making patient centricity a reality in real-life trials.

In the spirit of patient centricity, we will also be weaving the story of a patient through these articles, to relate the theory back to the people that matter. We’re calling our patient María; she’s 40 years of age, married with 2 small children, and working full time, as is her husband. She’s a native Spanish speaker originally from Mexico, now living in the US, with functional (but nowhere near fluent) English as a second language. María learned about the opportunity to take part in a clinical trial through her community health center, and is hoping to learn more about her general health and her illness, and to benefit medical research for the Hispanic community.

So, to get us started on our journey, let’s look at what patient centricity actually means.

What is patient centricity?

Patient centricity has been defined as “putting the patient first in an open and sustained engagement of the patient to respectfully and compassionately achieve the best experience and outcome for that person and their family”.[1] Essentially, it refers to an approach to clinical research that focuses on patients first and foremost – centering them in the process, and ensuring they are involved in designing it.

All of which seems pretty obvious. After all, what is a clinical trial about if not the people it is intended to treat? Which begs the following questions: What is so revelatory about this approach? And why is it under so much discussion right now?

Well, in answer to the first question, as is captured so well in this article by Pablo Graiver, Founder of Antidote Technologies, historically, clinical trials have actually not been about the patient at all, but about the trial. Patients have had to fit the trial rather than the other way around, and have seen little benefit (even altruistic) from their participation. As he notes, the prioritization of the trial over the patient is patently obvious even at the level of the most basic language used – “…patients had to be recruited, randomized, blinded, and became subjects the moment they entered a trial. The choice of words may have a sensible explanation from the point of view of the trial but they still sound cold and impersonal when one’s on the other side of the table.” So – believe it or not – this is indeed a new concept; a new way of thinking about clinical research. Now onto the second question.

Why are we talking about it?

If we can, therefore, agree that patient centricity is a relatively new approach to clinical trials, the next logical thing to think about is why the sector feels a new approach is needed. What was wrong with the old one? On this subject, the numbers more or less speak for themselves. Currently, about 30% of patients enrolled in a clinical trial drop out.[2] And it’s generally agreed by the industry that about 40% of these dropouts are for avoidable reasons. In the case of María (our fictional patient), for example, the cost of travelling to the site, plus what that means in terms of childcare and time off work, may be contributors to a decision to drop out of her trial. Add to that the language obstacles she’ll face in an English-language-only trial, and the reasons to quit are starting to stack up! It can cost an average $19,533 to replace a dropout on a clinical trial and can slow the process down by over a month.[3] (And that’s if you do manage to find a replacement. If you don’t, it can mean calling time on the entire trial, letting existing participants down, and losing the time and money that have already been invested.) As well as these general recruitment and retention issues, there are the stats relating to diversity of participants. As it stands in the US, for instance, the majority of participants remain non-Hispanic white men, with the enrollment of ethnic minorities actually decreasing in the last couple of decades.[4] This means that, even where trials reach completion, the effects of the relevant drug often remain untested in great swathes of the user population. We really need participants like María! It’s pretty safe to say, therefore, that current models are yielding less than ideal results, and an approach which could go even some way to solving these problems would certainly be worth at least considering.

Is patient centricity the answer clinical research is looking for?

In terms of improvement, patient centricity certainly seems to be moving things in the right direction. We’re seeing stats from our clients suggesting that initial efforts to center the patient are already reducing dropout rates by at least 10% – saving many hours and hundreds of thousands of pounds in the process. This time and cost saving means clinicians can spend more time with participating patients (rather than on the admin of recruiting replacements). Plus that time and money can also be used to fund further clinical trials (rather than salvaging existing ones). Not to mention, listening to a diverse group of patients and designing trials based on their input is likely to have a significant impact on the subsequent diversity of participation.[5] Patients like María, if they feel valued, may even speak to others in their community about clinical trial participation.

And so, if patient centricity is at least an answer, let’s discuss how one goes about making it a reality. What does that actually look like in terms of practical steps?

Step 1 is – obviously enough – include patients in the process!

Do this from as early as possible, and make sure you are including the relevant people, i.e. those by whom the drug will most likely be used. We attended a fascinating presentation at SCOPE this year given by a top 20 pharma company. They discussed a trial for a drug aimed at teenagers, and the lessons they had learned about the importance of including those teenagers (12-17-year-olds) in the design and development of the trial. Given the obstacles involved in communicating with patients under a certain age, they had been using assumptions based on adult insights to support teenagers, and found that it just wasn’t working. As soon as they were able to incorporate feedback from the teens themselves, everything changed. Assumptions about the things that were important to them were proved incorrect. (Assumption: teens are scared of needles; Reality: needles are waaaay down the list of things teens who need this drug are preoccupied with. Assumption: teens will hide their illness from others; Reality: teens will talk about their illness to anyone who actually takes the time to listen.) Involving the actual patients in the development of the trial, and communicating with them at the right level – linguistically and culturally – led to better engagement, better adherence, and ultimately, better results.

A number of other major research projects presenting at the conference cited their work with EUPATI and how it helped them gain invaluable patient input on their trials. (An example: taking multiple muscle biopsies from children with Duchenne Muscular Dystrophy is not ethical, and, as such, should not happen.)

And many presenters spoke of the improvement in results brought about by increasing the diversity of participants giving their input. We have spoken at length elsewhere about the specific importance of language and cultural nuance in communicating with diverse patient groups, and the very real impact of diversity on overall success, not just as a way to meet developing regulatory requirements.

Step 2 – Don’t apply the same model to everyone

This was another lesson learned by companies presenting at conferences across the last few months. Patients have diverse needs and accommodating these differences is vital for successful engagement and retention. Not everybody will like a particular model, however much of an improvement it is for some. And it’s essential to communicate with all patient communities to understand this. This necessitates language and cultural competence, as unclear communication may be just as harmful as no communication at all. For María, for instance, some decentralized clinical trial (DCT) elements may make all the difference. While an older patient may want and need to be on-site and out of the house. Don’t make assumptions; ask the questions and get meaningful answers!

Which brings us to Step 3 – Make sure to act on the answers.

One of the things we heard time and time again from patient testimony was that so much patient consultation feels like a tick-box exercise. It can be incredibly demoralizing to give your time and energy (sometimes in short supply) to provide insight, only to see no sign of actual outcomes. When, therefore, patients can see evidence of their advice being implemented, it acts as a great motivator for them to work with that entity again, benefitting the patients, the trials, and medical progress as a whole.

Step 4 – Show gratitude.

This is linked to Step 3. Beyond just being basically decent, showing your patients gratitude for their advice and their participation in a trial is linked to improved recruitment and retention rates.[6] As we’ve already mentioned, patients are more likely to work with people who are listening to them and showing that in a meaningful way.

That’s it for the theory. Now to reality, and how this new model is currently being implemented. Let’s take a look at some examples of patient-centric approaches being used successfully in the real world.

Examples of patient centricity happening now

Primarily, patient centricity, as it currently stands, is manifesting in attempts to reduce the burden on patients; in recognizing that patients are people with lives, and that clinical trials need to fit around their lives and not the other way around. This is not just because patients are people first; patients second, but also because this is a more realistic, sustainable approach for all involved. Just look at María and the many parts of life she has to juggle!

Technology

One example of patient centricity in action is the use of technology to streamline processes, taking a lead from consumer tech. Companies like Stitch are working now with CROs, research bodies, and pharmaceutical companies to apply consumer principles to the clinical trial experience. The idea is to give people localized, customizable tools to incorporate trials into their lives and manage them intuitively, in the same way they handle any major life admin. Also on the tech side is DCT adoption, which, by its very nature, allows for processes to be built around patients’ lives. More and more, the design of these trials is including patients right from the start, ensuring this effect is even greater.

Innovations in the patient-centric technology space are incredibly interesting, and bear discussion in their own right. And so, we will come back to this topic in our next article.

Lay summaries

Another example is the use of lay summaries. These are synopses of a clinical trial, its findings, results and progress, written for non-medical professionals (most importantly, for the patients). Long considered best practice, but not necessarily a priority (according to CISCRP, 61% of participants don’t receive results reports of any kind), lay summaries are now mandated by EU-CTR (in all EU languages), and there is much discussion about how to ensure they provide the information patients actually want and need to see. More on this, too, in a future article.

New informational content

Another example of patient-centric change is the creation of new content on the back of patient recommendations. This content is intended to help patients and their families to incorporate clinical trials into their lives, as one of many moving parts. This can be in the form of leaflets that parents of young patients give to employers to explain why they need to miss some work, or content they provide to their child’s school to explain the impact on that part of their lives. It can be information that patients give their friends and family to explain what they are going through when they can’t find the words themselves. Basically, think of all the ways an illness and its treatment impact someone’s life, relationships, and livelihood, and how simple and yet transformational it might be to soften that impact even just a little. We’ve had the opportunity to work on translating some of this content for different cultures and audiences, and its value is unmistakable.

To be continued…

Patient centricity, both as a concept and as a practical approach to clinical research, is certainly more than a new way to package old ideas; more than a buzzword on which to hang a presentation. As we have seen above, it’s changing the focus of research and placing it, rightfully, on the people who matter the most in the process; people like María. Over our next few articles, we’ll look more at how this is being applied in patient engagement and communication; technology and translation – topics that are particularly relevant to what we do, and which touch every part of the mission to put patients back at the center of clinical research.

If you are working in patient recruitment and retention, engagement, or any other area of clinical trials, and would like to discuss how translation can facilitate and improve your work, please get in touch. We’d love to hear from you!

[1] https://innovations.bmj.com/content/3/2/76

[2] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3684189/

[3] https://mdgroup.com/blog/the-true-cost-of-patient-drop-outs-in-clinical-trials/

[4] https://www.cell.com/med/pdf/S2666-6340(20)30075-1.pdf

[5] https://www.iqvia.com/library/white-papers/how-clinical-trial-design-impacts-enrollment-of-diverse-populations

[6] https://myscrs.org/resources/showing-patients-gratitude/