Episode Number: 057
Release Date: March 31, 2023
Guest: Bruce Hellman & Ben James
Connect With Guest:
Bruce Hellman on LinkedIn (https://www.linkedin.com/in/brucehellman/))
Ben James on LinkedIn (https://www.linkedin.com/in/ben-james-2157221/)
Guest Biography:
In this episode, we will explore the role of design in clinical trials, with a focus on electronic Patient Reported Outcome (ePROs).
Most clinical research professionals are so focused on protocol development, data collection, and analysis that it’s easy to overlook the importance of well-designed technology that supports clinical trials.
One such technology product is electronic Patient Reported Outcomes or ePROs. ePROs are surveys that are presented to and completed by clinical trial participants as part of the study requirements.
To learn more about ePROs and the role of design in clinical trials, I invited Bruce Hellman and Ben James on the Clinical Trial Podcast.
Ben is the Chief Design Officer and Co-founder at uMotif. Ben leads the design team and is responsible for product design and innovation at uMotif, with the focus of bringing consumer-grade experiences to the life sciences industry.
Bruce is the Chief Patient Officer & Co-Founder at uMotif. Bruce is uMotif’s entrepreneurial leader and co-founded the company along with Ben in 2012.
Enjoy!
Sponsors:
This podcast is brought to you by Slope. Slope drives operational excellence for highly complex, sample-intensive, early-phase clinical trials. The platform transforms chaotic clinical trial supply chains into protocol-specific operational workflows for sponsors, CROs, clinical research sites and labs. Learn more at https://www.slopeclinical.com/
This podcast is brought to you by Florence Healthcare. Florence eliminates chaotic workflows in clinical research operations with remote access and digital workflow platforms. More than 37,000 study sites, sponsors, and CROs in 90 countries trust them to accelerate their operations. To learn more, visit https://florencehc.com
Resource and Links Mentioned:
Patient Reported Outcome (PRO)
Health Technology Assessment (HTA)
ISPOR – The Professional Society for Health Economics and Outcomes Research
Clinical Outcomes Assessment @ Food and Drug Administration (FDA)
Health Insurance Portability and Accountability Act (HIPAA)
General Data Protection and Regulation (GDPR)
Abbott’s Freestyle Libre Medical Device/ Glucose Monitoring System
British Broadcast Channel (BBC)
Nature Article: How the weather affects the pain of citizen scientists using a smartphone app
Books and Literature Mentioned:
The Hard Thing About Hard Things – Ben Horowitz (Amazon, Barnes & Noble)
The Intelligent Investor – Benjamin Graham (Amazon, Barnes & Noble)
Built to Sell – John Warrillow (Amazon, Barnes & Noble)
Show Notes:
[0:20] Kunal Intro and Background on Bruce Hellman and Ben James
- Bruce Hellman
- Chief Patient Officer and Co-Founder of UMotif
- Previously worked at British Biotech
- Management consultant at Circle
- Ben James
- Chief Design Officer and Co-founder of UMotif
- 20 Years of experience in interaction and product design
- Previously managed an interaction design consultancy firm High Rise Design
[2:40] Sponsor Break: Slope (https://www.slopeclinical.com/)
[3:38] Bruce Hellman and Ben James Join
[4:41] How did Bruce and Ben Meet and What Problems are They Trying to Solve at UMotif?
- Originally started out of a mutual interest in creating tools that helped Parkinson’s patients track their day to day health
- Saw an opportunity when looking at the commonalities in patient experience across different conditions
- Got initial funding through the UK Cure Parkinson’s Fund
[8:03] Basics of Clinical Outcome Assessment and Patient Reported Outcome and Why They are Important
- Clinical Outcome Assessment: a method used in clinical trials and healthcare to evaluate the effects of a medical treatment or intervention on patients
- Patient Reported Outcome: Subset of Clinical Outcome Assessment that is completed by the patient
- Clinician Reported Outcomes: Subset of Clinical Outcome Assessments that are completed by a physician or investigator
- When done electronically they’re often called eCOA or ePROs
- Essential for trials and can be their primary endpoint
- Health Technology Assessment (HTA): pathway towards reimbursement for a medical product
[10:22] Current Clinical Trial Approach to Collecting Clinical and Patient Reported Outcomes
- Traditionally assessments are captured on paper
- Electronic forums have become more popular with the advent of Palm Pilots, Smart Phones and Tablets’
- Issues with markings/messiness of paper outcomes have been part of the driver for the shift to digital assessments
- Digital also improves patient experience
- eCOA Consortium looking at how to migrate paper forums to digital
[13:58] Patient Questionnaire Compliance and Quality
- Compliance is partly driven by study design
- Easiest to capture data right before or right after study procedure
- COVID partly a driver for change: electronic forums mean you can capture more data with less visits to site
- Electronic forums help trial to be more patient centric and accommodating
- ISPOR Export Task Force and Critical Path Institute have verified that quality loss isn’t an issue with electronic case forms
[18:05] Determining What Software or Technology Works Well for Patients
- Part of the the issue with older designs is that they were made to capture data but didn’t consider the experience of who was entering it
- UMotif started by working with patients directly
- Research teams may not know what “Design” is but they do understand the human experience piece of research
- Showing end to end experience through client workshops helps to highlight value
- Recommend going 100% digital for quality. Regulatory agencies like quality of all digital approach
[24:41] Sponsor Advice When Selecting Vendors for EDC and ePROs
- Study teams sometimes inclined to go with single supplier for all things from eCRFs to EDC but this may sacrifice patient experience
- Companies should pick their products based on how it best helps the end user even if those products may be from different vendors
- Integration between systems is secondary to making sure the user has the easiest experience
- Variable level of collaboration between vendors to integrate their systems with each other
- UMotif has had success working with some EDC vendors
- EDC Vendor Partners with UMotif not public at time of interview
[29:25] The Role of Electronic Clinical Trial Technology Design in Participant Experience
- Working with patient directly is key to success
- There is both the technology factor of patient experience and the trial design aspect of patient experience
- You need to work with both patients directly as well as sponsors/CROs to make sure your technology meets everyone’s needs
- Design doesn’t just include patient experience but also how the information is databased and reported out to sponsors
- Working with sponsors you want to drill down to what systems are they using, what is their workflow, and what experience do they want sites to have
- Working with research sites helps to identify “friction points”
- Helps to optimize and improve technology
[24:41] How Many Sites has UMotif Worked with?
- 100s of sites across 60 different countries
- Americas, Europe, Asia: Japan, South Korea, China
- Worked with both large sponsors and CROs as well as mid sized biotech companies
- Start with understanding the study design and the desired user experience
[38:54] Strategy for Provisioning Clinical Trial Hardware
- Often a BYOD (Bring Your Own Device) approach on studies
- Patients or sites download their app on phones, tablets. Android and iOS compatible
- Sometimes sites provision devices for consistency in experience
- Recommend clinics have a stock of provisioned devices for a study
[41:18] Legal Elements of Managing Electronic Clinical Trial Data
- Data rights at the outset of a project is a very important topic to make sure you’re aligned with local regulatory requirements
- HIPAA, GCP, and GDPR are guiding requirements
- Also important to consider the local requirements and requests of study partners
[43:44] Sponsor Break: Slope (https://www.slopeclinical.com) & Florence (https://florencehc.com )
[46:01] Questions Sponsors Should be Asking When Selecting Clinical Trial Suppliers and Vendors
- Make sure platform is compliant with local regulations
- Ensure system can scale and integrate with other study systems
- Can data be transferred seamlessly and in high quality?
- Study teams don’t ask as many questions about design as they should
- UMotif has found success in these conversations framing them more as a discussion/presentation of potential solutions
- Important to always highlight what the patient/user experience is desired to be with the technology
[52:26] Language Support for Clinical Trials
- Platform was built to be able to handle any language
- Worked with English, Spanish, French, Japanese, Korean, Chinese
- Local level support is really valuable for patient experience
[24:41] Wearable Devices for Clinical Trials
- Exciting to potentially integrate wearable devices into the ecosystem of technology used for clinical trials
- Important wearables are tailored to their application for the study
- Live-streaming of data out from these devices to the cloud can be really powerful
- Hypo-Metrics study
- 600 patients across numerous EU Countries to monitor hypoglycemia
- Used Abbott glucose monitor, Fitbit, and UMotif ePROs
[58:29] Home Sample Collection
- Guideline materials and support for patients to do their study work at home is important to ensure they collect samples and provide data correctly
- Working with study team and patients helps to optimize the home sample collection process to ensure best patient experience
- Examples like: ePROs, Bloodspot tests, and symptom data
- Not every solution needs to be technical, think about people first
[1:03:35] Best Practices for PRO Selection and Data Collection
- Important to let science and study goals guide the selection of best instruments and tests
- Challenge arises with some of the older instruments and tests that were designed decades ago
- New technology and electronic forms help to make the data collection process more smooth
- UMotif Body Mapping Technology: Worked with University of Manchester to develop a way for patients to draw on device which areas of their body are experiencing symptoms
[1:07:31] Being Inclusive to Older Patient Populations with New Technology
- Make sure design and build is accessible to people
- UMotif data has shown women between ages of 60-65 have actually been some of their most consistent users on studies
- See pretty good adherence to studies even up to 85. Notable drop off in adherence after the age of 85.
- Important to test your interface with different groups of users – motor control, reading age, configurable system that fits the patient group, take the technology to the patients
[1:12:11] Large Decentralized Parkinson’s Study
- 18,000 participants in a decentralized study
- Study with Manchester University called Cloudy with a Chance of Pain
- Launched on the BBC for people to download on their phone
- Lead to a couple of publications in Nature
[1:15:17] Books and Resources that have Inspired Bruce and Ben
- The Hard Thing About Hard Things – Ben Horowitz
- The Intelligent Investor – Benjamin Graham
- Built to Sell – John Warrillow
- The Wim Hof Method: Activate Your Full Human Potential – Wim Hof)
[1:19:46] Sponsor Break: Slope (https://www.slopeclinical.com/)
Major Themes:
- In the last couple of decades, digital case report forms have moved in to replace paper forms. These digital forms offer a better patient experience while also providing the opportunity to collect data more consistently and in different locations like at home.
- When designing electronic case report forms for studies it is important to understand the desired workflow and end user experience. Getting feedback from Clinicians and Patients is critical to good design practices
- Improving the quality of patient experience and the overall inclusivity of studies helps to make the overall research higher quality.
Quotes:
- “The genesis of a lot of these systems that are there to capture data. They were originally designed as systems that clinicians use…. I think that really shows and these sort of patient facing pieces had to be bolted on to them.”
- “I think the best way is actually working with the sites to understand, you know, where their friction points are.”
- “If you start with a system that is designed for patients as well as clinicians, I think you end up with a different user experience.”
Audience Question:
Have you worked on any clinical trials that used electronic patient reported outcomes (ePROs) or electronic Clinical Assessment Outcomes (eCOA) to capture study data? What challenges, if any, did you face? Please share your experience in the comments below. I’d love to hear from you.?
