Reduce Patient and Site Burden in Clinical Trials

Client: Global pharmaceutical company | Role: Strategy | Year: 2018

Project Abstract

The Challenge: The current clinical trial system is not working for patients, sites, or sponsors. Patients who might benefit from clinical trials often are never offered them as an option, and trial participation imposes a significant time and travel burden. It is becoming increasingly difficult for sites to find and enroll patients who meet trial eligibility criteria, so clinical trials must become less burdensome for both patients and sites in order to broaden access and participation. Our client wanted us to explore how technology could help achieve this goal by facilitating a distributed model, in which patients would not have to come to a central trial site to participate in a trial.

The Solution: We developed a detailed overview of opportunities and potential technology offerings to reduce site and patient burden, an ideal-state trial model, and a pitch presentation the client team could use to get organizational buy-in for the ideal-state model.

Outcomes: Our client is using this research to inform internal process changes, initiatives, and partnerships to make their trials more patient-centric.

Project approach

Timeline: 9 weeks

Project team: Behavior change designer, behavior change design director, researcher, visual designer

Team contribution: I was one of two primary project contributors. We worked with a Mad*Pow user experience researcher at the beginning of the project, who conducted provider and patient interviews, and a visual designer near the end of the project, who created final graphics and diagrams. I helped conduct and synthesize information from the literature review and interviews and map insights to each clinical trial stage. The project lead and I worked together to develop recommendations, map the clinical trial system for our visual designer to refine, and develop a strategy for our client to pilot our recommendations. I was responsible for creating and delivering the final strategy presentation to our client.

First, identify challenges and opportunities that could be addressed though a distributed clinical trial model.

In the first phase of the project, we needed to get up to speed on the current clinical trial system in oncology, including activities and participants in each phase of a clinical trial and barriers to patient access and engagement with clinical trials. We spoke with stakeholders, external experts, patients, and providers to hear about challenges within the current system and their reactions to the distributed clinical trial model. We also conducted a literature review to understand barriers to patient access and engagement with clinical trials more broadly. We took our findings and mapped them in a spreadsheet to start making sense of the key phases of clinical trials and activities involved at each stage. This allowed us to start sorting opportunities and challenges by phase and stakeholder.
A key finding early on was that improving participation and patient access to clinical trials was less of a technological issue and more of a human issue. Though new technologies could improve communication with patients, ease trial management, and improve regulatory compliance, a barrier that came up time and again was that trial protocol design simply isn’t responsive to patient and site needs. To be truly patient-centered, the sponsor needs to involve both patients and sites in protocol design.

Key deliverables: Literature review, patient and provider interviews, interview findings report

Next, synthesize findings into a current-state map and work with our client to prioritize opportunities.

Once we understood the current state of clinical trials and key challenges, we identified opportunities at each trial stage. We also created an ecosystem map to visually represent trial burden at each stage for patients, sites, and sponsors and highlight areas of overlap.
We used these references to facilitate a workshop with our clients and identify the highest value opportunities. Together, we selected the most promising strategies to incorporate into our final vision for an ideal-state distributed trial model.
During this workshop, our clients highlighted company initiatives that aligned with several of the opportunities we presented. We realized that a key deliverable to promote buy-in would be to represent how the company’s current initiatives mapped to our recommendations and show how gaps could be filled by working towards the ideal-state distributed trial vision.

Key deliverables: Overview of opportunities, co-design workshops

Then, synthesize these opportunities to present an ideal-state distributed trials model for immuno-oncology to “pitch” to the broader organization.

We took the insights from our workshop and developed an ideal-state map of clinical trials that highlighted current initiatives and how they fit into the broader vision for improving patient access. We then distilled over 100 pages of findings, reports, and diagrams into a 15 minute presentation that our clients could use to win support for the initiative.
I created the final deck that outlined the need, the current state of clinical trials, the consequences for not shifting to more patient-centered approaches, and finally, the vision for distributed trial technologies in immuno-oncology. This vision relied on technology only to the extent that it could free up sites and sponsors for more meaningful patient interaction.

Key deliverable: Ideal-state distributed clinical trial ecosystem map and patient journey map

Finally, identify a strategy and potential partners for our client to implement our recommendations.

Our final deliverable was to present a strategy for moving from the current to ideal state. Our recommended pilot initiatives began with low-tech solutions to ensure that the company would add technology (and complexity) only when necessary.
Each pilot recommendation included a rationale, guidance on how to initiate the pilot, potential internal and external partners to work with, and outcomes to track to evaluate success.

Key deliverable: High-level strategy presentation for our clients to gain internal support for the initiative