What was the original genesis and drive for creating a patient portal?
Janssen is deeply committed to “Better Trials. Made Together,” which is all about leveraging insights to optimize the clinical trial experience. We believe the best clinical trials are the ones where, together, we generate robust and groundbreaking data and at the same time prioritize patient safety, privacy, and convenience. We have mined available insights across the pharmaceutical industry and conducted an extensive body of patient voice work ourselves. We learned, based on listening to the patient perspective, about the huge opportunity to address unmet participant needs by providing a connected experience in clinical trials.
My Trial Community is designed to increase engagement, transparency, understanding, awareness and education for the patient and participant, and demonstrates our deep commitment to clinical trial participants and investing in cutting edge capabilities and services for patients participating in clinical trials.
Now, we’re getting ready to officially launch our first full-fledged trial portal with a couple of trials. We’ve done beta testing with patients to get a sense of what things we might need to improve upon, and what things they consider to be most valuable.
"Based on our insights, returning personal trial data and study results is a key value driver for patients. Janssen leverages insights to co-create solutions that provide the clinical trial transparency and trust that patients deserve."
What can patients expect from the portal, in terms of materials and results?
Patients can expect clinical trial education and support before they become participants. Once they make an informed decision to participate, they can register for MTC to conveniently access details about their trial, information on trial progress and visit prep, and a subset of labs and vitals. And, where relevant, patients can get back a plain language summary that summarizes the results of the trial. Based on our insights, returning personal trial data and study results is a key value driver for patients. People are decision-makers in their health journey, and Janssen leverages insights to co-create solutions that provide the clinical trial transparency and trust that patients deserve.
What preferences for returns were identified from patient feedback?
Through the insights that we developed ourselves, and some existing data, we knew that many patients were very interested in getting their data back and seeing summary results. The Center for Information and Study on Clinical Research Participation (CISCRP) cites that, an overwhelming majority would like to see this information, but less than a quarter do. As mentioned previously, data return is quite valuable to the patient. So, we want to provide that information to the participant. We also know quite a few patients have very low awareness and understanding of what a clinical trial is, if they were not previously trial-exposed.
So, there is a need for basic primers and education around clinical trials. Even for some trial-exposed patients, things come as a surprise. They’re unclear on what to expect in the trial process and want to be better prepared and informed. We embed the patient voice into everything we do through MTC to help address such needs.
What was that process of creating patient-literate and patient-accessible content, from the plain language summaries to the types of data that you were returning?
We took a highly cross-functional approach to mapping this out. We worked closely with our Patient Insights Team and we conducted stakeholder interviews with some of the therapeutic area leads. We also worked very closely with Health Care Compliance to look at what was needed and to find compliant ways to make that happen.
First, we leveraged the insights we had, and we came up with a hypothesis of what we thought would be the key features and pieces of content that patients would need.
From that hypothesis, we then tested it with stakeholders: sites, patients, and colleagues who help with operations to determine how it married up to our hypothesis. We then looked at that delta and developed a new prototype for the content.
And we share the results with stakeholders to see if there was a good level of satisfaction with the findings, and if the information met the mark for what they valued. We’re planning on iterating on this process to further evolve what type of content we include on the site. It could be the case that some content gets replaced, that certain content will remain evergreen, but we’ll build from there. It really will hinge on maintaining this sound and strong feedback loop with the appropriate stakeholders.
What was the process of collaborating with the sites on delineating who would troubleshoot any access issues, or provide follow-up conversations, etc?
What we were trying to do was meet patients’ needs while being very mindful and empathetic around the existing workload a site is already doing. We were trying to make their jobs easier. So, we did partner with site staff to understand their journey and key pain points.
To ease the burden, we created a help desk for MTC that patients can use to troubleshoot technical and operational site issues. This prevents unnecessary outreach to the site.
Where we ask the sites for support is around helping to introduce MTC as an optional feature that patients can participate in. We conduct site training and supply collateral materials and talking points to aid in the onboarding. Sites also ensure clinically relevant laboratory and other test data is discussed with patients before a site approves any data to be transferred to the patient portal.
"Start with a clear, informed vision and strategy. “Informed” means stakeholder-informed, patient-informed. Consider cross-functional members that should be involved and partner early—especially for leadership alignment."
Can you provide any development advice? How far back should the planning begin? Who are the key stakeholders to involve?
It’ll depend on the build, actual team structure and organizational structure. Every company will have their own requirements and processes to follow, but I would generally start as early as you can, because the lead time to launch is lengthy.
Start with a clear, informed vision and strategy. “Informed” means stakeholder-informed, patient-informed. Consider cross-functional members that should be involved and partner early—especially for leadership alignment. For us, it was critical that we worked with our Janssen Clinical Innovation (JCI) team, compliance, clinical operations, IT and patient insights in the beginning. Understand requirements and current business capabilities.
In some cases, you have the capabilities in-house and other cases, you’ll need to outsource.
Creating a sound feedback loop and implementing throughout is critical. Especially with anything digital, it’s going to be highly iterative. You want to make sure that in the design and development, you are consistently getting feedback from the right stakeholders so that you’re ultimately developing something truly valuable to the patient.
Partner effectively to find a solution that is workable and introduces minimal friction. There’s a way to brainstorm on how to get to a better solution that drives a better experience for the patient.
And lastly, work collaboratively to develop a clear and effective change management plan. Anytime you’re introducing something new to an organization, to a patient population or stakeholder population, you always have to lead with empathy around how that’s going to impact people and the way that they work and think. It’s important to communicate what’s being developed and why, and the cross-functional impact and support being provided.
"It takes prioritization, alignment, and effective planning to strike this balance. Start with your minimally viable product but prepare an infrastructure that facilitates long-term goals."
What lessons can you share?
The first, as we say at Janssen is, “Ask. Listen. Act.” Listen to your stakeholder’s perspective first.
Another is balancing the short-term needs with the long-term vision. Knowing our resources and what we envision, there’s only so much we can get done in the short term. It takes prioritization, alignment, and effective planning to strike this balance. Start with your minimally viable product but prepare an infrastructure that facilitates long-term goals. Don’t lose sight of that.
Another lesson is that this entire process – and innovation in general – requires a lot of trust building and leading from a place of empathy. Remember to be human-centered.
Finally, communicate clearly and often. Emphasize purpose, plans, roadmaps, timelines, so that the involved parties can manage expectations and be the best champions.
For more information on Patients as Partners, visit patientsaspartnersconference.com.
