While the use of the decentralized trial format was on the rise before COVID-19 landed, it is still a growing and evolving component of the research industry. To help meet sites’ ever-changing needs and encourage greater DCT participation, the patient-centric technology specialist has launched its Site Network Council (SNC). The council comprises a group of clinicians and research leaders who will lend their experience and insight to inform progress.
“There are still many problems in clinical research, and like Medable, I’m passionate about being part of the solution,” said Judy Galindo (director of research and co-owner of Sun Valley Research Center, and a founding member of the SNC). “We aim to inform Medable’s products with insights from experience working in a large, Hispanic community while helping to ensure Medable’s tech innovation makes research more efficient for site personnel.”
Mary Costello, head of site and investigator network for Medable, took the time to discuss the SNC with Outsourcing-Pharma, explaining the inspiration behind its formation and its potential to impact decentralized trials.
OSP: Could you please talk about some of the ideas and conversations that led to the creation of the Site Network Council (SNC)?
MC: Increasingly, many sponsors and research organizations have committed to raise the voice and role of patients, but we were struck at the absence of similar support for investigator sites. They are the cornerstone of research, even decentralized research.
Tufts Center for the Study of Drug Development has a decade's worth of data showing the increased complexity of clinical trials, and that burden is largely absorbed by sites while their revenues remain flat, and many are struggling.
On top of that, early DCT discussions positioned the future as "siteless," where all future trials would work under a central investigator model. Instead, we want our solutions to enhance the work of sites, not replace them. We want to reduce sites’ administrative burden and free up more time for clinical work and human interaction – the heart and soul of all trials; after all, you can’t be patient-centric, if you are not site-centric. The site is patients’ connection to the study.
When we introduced the concept of Medable’s Site Network Council to the site community, it was very well received. Each member asked to participate enthusiastically responded and brings novel ideas, real-life examples, and powerful advice on how to help sites, and by extension, patients.
OSP: Please tell us about the eight founding members and how these folks were tapped to be SNC members.
MC: We reached out to sites that we had relationships with initially and, given their enthusiastic response, expect many more sites to get involved as we seek to involve many different types of sites from healthcare organizations to standalone researchers and academic medical centers, even pharmacies. We want the voice and perspectives from a diverse set of sites as well as sites that represent the diversity in the US, and we will be extending membership to sites in the EU this year.
We want SNC members who share our passion for open collaboration to improve clinical research. To date, Medable’s SNC consists of the following inaugural members:
- Stephanie Abbott, research director at Western Washington Medical Group
- Sarah Grover, site startup specialist at Elligo Health Research
- Melissa Palchak Opraseuth, chief operating officer at par80
- Patricia Larrabee, CEO of Rochester Clinical Research
- Barbara Keskiner, business development/regulatory affairs director at Clinical Research
- Judy Galindo, director of research and co-owner/founder of Sun Valley Research Center
- Steve Clemons, president and CEO of VitaLink Research
- Katelyn Jetelina, assistant professor at UT Public Health System
These impressive site representatives offer a transparent window into modern research environments and will help Medable create DCT workflows that meet sites’ changing needs and enable their greater participation in DCTs.
OSP: Why is diversity among the founding members important?
MC: Both site diversity and the diversity of roles for our members were critical in the formation of Medable’s SNC so that we could capture the opinions and perspectives from a representative group. From site founder to principal investigator to sub-investigator to regulatory experts to study coordinators…we wanted representation across the many types of professionals that support research. We also recognize many people have served in multiple roles during their careers and even currently perform multiple roles, so we felt it important to capture that reality.
Further, we wanted both the perspective of younger members who came of age when tech was already part of the process and experienced industry leaders. We also wanted to ensure that we draw on the backgrounds of the sites that are part of diverse communities, such as Judy Galindo’s Sun Valley Research Center, and better understand those environments.
OSP: How will the work of the SNC benefit the members, Medable, and the overall research industry?
MC: Members of the SNC will provide them with a greater sense of accomplishment and influence on the future of research. Medable shares any product or process adjustments we make as a result of their input so SNC members see their voices in action. Some of these refinements are minor while others involve wholescale transformation of a training program.
We aim to create a culture where the site perspective becomes a part of Medable’s DNA and we hope this translates outside of Medable as well. Our products will increasingly reflect site needs and set a bar for the industry – and as part of that, we also hope to give a larger share of voice to this critical community of stakeholders.
OSP: Have you begun your work, or are you about to? Either way, please tell us about the SNC’s first goals.
MC: The SNC started formation in the first quarter of 2021. Our focus areas have been not only on product – from ideation through to user testing – but also to two other main areas:
- site training
- change management, specifically to help ensure that sites are comfortable with modern technology, and they understand its value to help them and patients.
Sites are often left out of this process – and are hardly even shown demonstrations of a technology before they are forced to use it in trials. To that end, also, we are focused on how to ensure a scalable and effective help desk/support function for sites that keeps trials on track and doesn't create additional burden on the site teams.
OSP: Do you have anything to add?
MC: Medable has invested in and committed to training its internal teams to ensure every Medable employee gains a deeper understanding and appreciation of what it means to work at a clinical site. Specifically, we are piloting a program that is already providing great payback and is achievable only through the generosity of time from our SNC member sites.