The global COVID-19 pandemic has seriously shaken up the clinical trial industry’s ability to continue its work. In the face of travel restrictions, participant fears, and the desire to keep patients and staff safe, sites, sponsors, and other stakeholders are wracking their brains to create and integrate technology that keeps research going, without sacrificing the health of trial teams or participants.
ConvergeHEALTH, a business unit of Deloitte, has launched MyPath for Clinical, a technology platform intended to help streamline the execution of clinical trials. According to the company, it is designed to help accelerate digital trials by connecting patients, caregivers, clinical teams, investigators, and other parties to elevate trial matching, boost engagement and retention, and provide a better patient experience.
Chris Zant, chief digital officer of ConvergeHealth by Deloitte, explained before the launch of the platform, the team conducted focus groups, communicated with investigators, and spoke to patients about their experiences and perspectives to collect useful insights about the trial experience and technology. One thing coming out of those conversations, he said, is a need to better engage and inform patients.
“The patients we spoke to told us, ‘[Trial staff] ask a lot of questions, and they hand us a lot of materials, but they don’t give us back much,’” he said, adding that MyPath aims to support better engagement and interaction between sites and patient participants.
Dawn Anderson, life sciences specialist with Deloitte, told OSP that the company has been working on digital clinical trials and technology for approximately 15 years. That stretch of experience, and the extended feedback-gathering conversations with stakeholders, helped inform the development of their trial technology.
“With MyPath for Clinical, the idea is to put the focus on the patient, to deal with what in the past has been difficult in clinical trials,” she explained. “It is really focused on giving them a better experience, which helps get them to stay in those trials and give us quality data.”
OSP connected with Anderson and Zant about the MyPath for Clinical Platform, and the importance of putting patients at the center of clinical trial technology offerings.
OSP: Chris, you’d said, “Navigating trials as a participant can be harder than navigating a disease as a patient.” Could you please elaborate, and maybe share what trial professionals don’t understand about how frustrating that can be for participants?
CZ: Clinical trials include all the “normal” considerations of having a debilitating, chronic, or terminal disease and introduce the incremental concerns around placebos (“did I get the real medication”), efficacy (“will this new drug be effective”), side effects (“will I experience unknown or significant side effects”), and also add the burden of incremental check-ins, appointments, and testing.
OSP: Could you please elaborate on the things a trial team can gain if they make sure the patient experience is built in from the get-go, rather than at the tail end?
CZ: Experience, by definition, is about the journey, the path, and the steps we take along the way as humans moving through the world. A meaningful experience cannot be dropped in at the end but must be part of the fabric of the design, the spirit of the solution; we must think about it from the start and be cognizant of the implications on every step of the process. A well-designed patient/participant experience should be at the heart of a solution for digitally enabled clinical trials.
OSP: Dawn, as you pointed out, your team has been working on digital and decentralized trial solutions for the last 15 years—whereas other companies that might have been looking at such solutions since before COVID are still at the starting line, more or less. Can you share some thoughts on the perspective that affords you, having those years of insights?
DA: Not our Deloitte team but the industry did its first virtual trial 15 years ago (at Pfizer). The challenge at the time was that technology - Smartphone apps, digital technology platforms, and Bluetooth-enabled connected medical devices didn’t exist or were not yet as prevalent as they are today.
It was hard to do telemedicine visits (no Zoom) and difficult to collect meaningful clinical data (vitals, EKGs, ePROs, etc.) without being in a doctor’s office. The industry deemed virtual trials not yet “ready” and continued to design studies using a traditional site model where patients went to sites to have testing done. But today almost everyone carries a Smartphone, Uses Apps and we have thousands of Bluetooth-enabled devices for everything from blood pressure to EKGs – which allows us to capture more real-time data outside the doctor’s office.
Along with this came the focus on patient engagement – and patient focus groups told Pharma that it was a burden to go to the site and asked “why if they can bank on their phone, can’t they do more clinical activities at home. Pharma has never been fast to change so many in pharma – (1-2 years before COVID) – started to plan their strategies for enabling digital clinical trials with a timeframe to start to develop them slowly with a goal toward doing more in 3-5 years.
Then along came COVID – and suddenly the industry had no choice and 3-5 years became last year (2020). Stay at home orders meant if we didn’t go digital a trial would just stop – meaning nothing would be ready for market. So the industry had to adapt and do it quickly.
At the high point of the COVID shut down more than 50% of trials had some form of virtual visits – and today most pharma feel that they will keep at least 20% decentralized and plan to scale that to 50% of trials decentralized in the next 5-7 years . . .COVID and the prevalence of at-home healthcare technology has created the perfect “storm” needed to shift the paradigm to digital clinical trials . . .
OSP: Could you please tell us how different the patient experience looks when a patient-centric approach is considered much earlier in the process?
CZ: It depends on the specific solution, but a well-designed patient/participant experience will embrace the disease journey of the individual patient, address their fears, support their hopes, and help encourage them to follow the required protocols while engaging them in the journey and increasing adherence with study tasks.
OSP: Could you please talk about some of the key challenges in patient identification, and how you work to cut through some of the ID and outreach obstacles with your solutions?
CZ: Patient identification and enrollment are complex topics and while digitally enabled trials MIGHT make trials more appealing to patients in and of themselves, they do not necessarily increase enrollment. That said, broader digital engagement strategies extending outside of trials and into disease state and/or commercial (in-market) support programs could generate opportunities to “feed” patients into digital trials, by leveraging similar digital tools and consenting patients (or disease sufferers not currently on therapy) into sharing their health information for analysis and alerting to study opportunities.
OSP: Do you have anything to add about what the future of patient-centricity in trials might look like in the coming months and years?
CZ: Better-supported patients lead to better real-world evidence—and stronger outcomes. An experience and solutions that improve the sharing of information among patients, investigators, and sponsors in a way that transforms the overall clinical experience will transform the future of clinical trials by:
- Connecting patients, investigators, and sponsors through personalized education and actions, communication, and dashboards that deliver a real-time understanding of the clinical trial process and more data-driven conversations
- Enabling more direct patient data capture in hybrid virtual and digital clinical trial designs, reducing the burden on the patient and eliminating common barriers to clinical trial recruitment and retention
- Creating transparency and access by investigators and sponsors to real-time patient data, providing a simplified path to adherence, compliance, and study data.