Drug development teams, even those that speak of incorporating patient voice, often underestimate the potential impact that including that voice can have in the process. They frequently don’t even begin to consider their trial participants until well after the protocol, educational material, and design are underway.
To learn more about how and why trial teams can better incorporate patient voice all along the path, Outsourcing-Pharma spoke with Natalie DiMambro, vice president of product commercialization and training at Within3
OSP: Could you please share your perspective on how the clinical research field’s understanding and prioritization of incorporating patient voice has evolved in recent years?
ND: Historically, the life science industry is known for its commitment to proven methods for collaborating on processes like protocol development. But now, companies are facing shifting expectations, both from consumers and from business partners.
One of the primary forces for change here is the expectation around the patient voice. The bar for patient adherence is high, and if you struggle to engage patients throughout the process, you might find that the trial is not successful or that the resulting product is less likely to be widely effective.
To increase the likelihood of success, clinical research teams are evolving the old operational model and favoring a more patient-centric approach. In practice, this might mean more patient engagement from early stages, co-design of the trial process, and focusing on things like accessibility and convenience during a study.
This focus also naturally supports increased diversity for previously unrepresented groups, because you’re addressing those access issues and eliminating barriers like physical distance or strict scheduling. What we are seeing in this evolution is an integration of the patient voice throughout the entire clinical development process, which benefits both the organization and the patients.
OSP: Traditionally, trial teams have touched upon patient voice concerns after the protocol, educational materials, and trial strategy are already formed. Why might this approach be a concern?
ND: By its definition, patient centricity requires trial sponsors to re-center operational strategies around patients. This means shaping processes with the patient voice coming first, not as an afterthought or filtered through a physician. After all, only a person experiencing a particular disease will truly know how it feels to be diagnosed with a condition, what it is like for them day-to-day, or how they wish to be treated.
In work like this, it’s important to remember that patients are more than their health condition. Discovering patient preferences after the trial strategy and protocols are formed could result in protocol amendments and delays. This information could include how the patient prefers to communicate with physicians or trial sponsors or their physical or logistical needs related to treatment.
Often, patients require additional education regarding trial requirements and expectations. By engaging patients earlier and more often, these unmet needs can be addressed during protocol development, leading to improved adherence and potentially better trial outcomes.
OSP: What are some of the ways trial teams can go further toward incorporating patient voice where needed, and earlier in the process?
ND: As mentioned earlier, it’s best to include patients from very early on in the process. For instance, this could mean engaging with patients to get their feedback on a proposed trial protocol. You could also set up a virtual resource center or community where patients can find the information they need or ask questions of experts or each other as they participate in the study.
In some cases, trial sponsors will check in with patients as a study progresses so they can understand why participants might discontinue participation, and make adjustments to lower that risk. And some feedback is more tactical, such as asking for input on educational materials.
It’s really in the trial sponsors' best interest to do this because recruitment and enrolment are the most challenging and most important elements of a successful trial. Patients are making a big commitment, and in some cases, they have a lot riding on their trial experience. If they don’t feel heard, if they don’t feel prioritized – that turns into a risk for the trial sponsor.
OSP: How can virtual engagement tools and techniques help the process?
ND: Virtual engagement offers a lot of advantages to trial teams and patients, and it supports two elements that can really impact trial success: participation and diversity. Virtual engagement really has a high likelihood of improved participation rates, because patients don’t have to travel or show up at a specific time. In an asynchronous environment, they can log in whenever they have time or feel able, which is important if they have health issues.
If you’re working with a very diverse group of patients, you want to make sure people can contribute equally, in whatever language they are comfortable using. And you’d want to offer privacy because people are discussing sensitive medical information.
Virtual engagement technology meets these requirements. Language translation means everyone is heard. You can anonymize people's identities or use questions that only a moderator, and not a whole group, can see. In this setting, too, trial sponsors or investigators can ask follow-up questions and get more information in a setting that’s not too intimidating or overwhelming.
OSP: What about diversity and inclusion—why is this important, and what advice do you have for trial teams looking to improve their DE&I?
ND: Drug and device development needs to take diversity into consideration because diseases and conditions affect people from every walk of life, and some diseases disproportionately affect specific populations. Designing a clinical trial with this in mind will generate more meaningful and applicable results which represent a true picture of who patients really are – not just the ones who have access.
Trial sponsors are aware of this, and they have a lot of conversations about it. The challenge can seem really insurmountable. But the truth is that these problems – language barriers, physical distance and schedules, trust in the medical establishment – can be addressed without overhauling the entire organization.
OSP: How can a company like Within3 help?
ND: The pharmaceutical and medical device industry relies on insights to drive strategy and make decisions. Traditionally, these insights came primarily from an elite group of key opinion leaders, and mostly from in-person interactions. But we live in a multi-channel world now, and in-person discussions are the tip of the iceberg.
We have social media, where patients form communities and experts share scientific information. There are patient advocacy groups that disseminate research. There are those medical congresses and one-on-one discussions between medical science liaisons and physicians. And this information comes in over email and through text messages and via in-person meetings. There is just much more happening, in more places, than ever before.
That’s a lot of data to process, and it can feel paralyzing, so insights management – obtaining, organizing, and analyzing all of that information – is a really critical activity. An insights management platform brings all of that together so teams have a much clearer picture of their disease community, a more efficient way to engage experts and patients, and a way to identify trending concepts in all those discussions they’re having.
The technologies that underpin insights management include network analytics, social listening, asynchronous virtual engagement, and artificial intelligence. At Within3, all of this is powered by human expertise, our client success teams, and data scientists, whose job it is to understand our clients’ goals. And that’s really at the core of effective insights management – building a strategy to reach those goals.