Site Perspectives in Decentralized Clinical Trials
By: Ayesha Rashid, PhD
Interviewee: Rebecca Kottschade, Director of Research Operations, Mayo Clinic
Site Perspectives in Decentralized Clinical Trials
By: Ayesha Rashid, PhD
Interviewee: Rebecca Kottschade, Director of Research Operations, Mayo Clinic
Decentralized clinical trials (DCTs) represent a significant shift in how clinical research is conducted, moving away from traditional site-centered models to more patient-centered approaches. This has implications for various stakeholders, including the clinical trial sites themselves.
Rebecca Kottschade, Director of Research Operations at Mayo Clinic, explained in an interview with Xtalks that post-pandemic, the industry is incorporating digital and decentralized capabilities into more traditional clinical trials and interventional clinical trials.
“We recognize that not every trial can be a fully decentralized clinical trial, but there is an opportunity to meet in the middle and have specific capabilities be decentralized to support our patients and make it easier for them to participate,” said Kottschade.
Despite the utilization of the same tools and strategies, the DCT experience is different for patients and the site. In traditional clinical trial models, patients and site staff are physically in the same space. With decentralized, off-site models, patients are participating from their home or community while staff are interacting with patients remotely. This brings about both new opportunities and challenges.
DCT Site Challenges
Staff not only have to navigate new remote tools and hybrid strategies in DCTs, but may also have to assist patients who are using various tools and devices at home if there is no designated technical support team.
With the advent of DCTs and advancements in technology, remote monitoring has become a major feature in some clinical trial models, including those that may not be fully decentralized, such as hybrid trials or even traditional trial models that may incorporate some decentralized components.
Remote Monitoring
Remote monitoring in clinical trials can offer an efficient and flexible approach to overseeing trial progress and ensuring data quality and participant safety. As the industry continues to evolve, adopting and adapting to remote monitoring practices will be essential for conducting successful clinical trials.
Remote monitoring involves the use of tools and technologies, often in a patient’s home, for measuring and collecting data. This can include the use of devices, software and mobile apps among others. When considering devices used in the home careful consideration needs to be made regarding their use. Questions should be asked about the device, for example, is it medical grade or a health and wellness device? Is the device approved for in-home use or does the data collected need to be validated by another device? Another question to consider by researchers and study teams: Is the device part of the invention or has it already been validated as a remote collection device?
If these types of devices are being used, it’s important to identify the points of interest being collected from the devices and validate that information with medical-grade devices, says Kottschade. Important considerations around the use of devices include their safety and ensuring patients know how to use them.
When working with remote monitoring, whether it be a wearable or medical device, an important consideration is understanding the implications for the patient and knowing how to support the patient remotely, explains Kottschade.
For example, there can be digital challenges or barriers as patients may not have readily accessible internet, a computer or a cell phone. This makes it important for a site to be equipped with the knowledge, understanding and expertise to help support patients when launching a clinical trial that has a decentralized capability.
Continuous advancements in technology and an increasing shift toward decentralized trials will only increase the demand and use of remote monitoring. Integration of artificial intelligence (AI) and machine learning for data analysis, and improving user-friendly interfaces for remote monitoring tools, are areas likely to see growth.
Adoption of such new technologies necessitates training for staff at sites, which can also involve supporting patients who are using the new technologies. Therefore, it is important to be able to adapt to new, evolving tools and technologies with the necessary training and support for site staff’s workload.
Patient Enrolment and Engagement
DCTs create enrollment opportunities.
Kottschade says, “In the discovery work we’ve done at Mayo Clinic, we recognize that financial and travel burden is critical for patients who want to participate in clinical trials. If we are able to have a conversation with a patient via a video visit, that can reduce a trip to the campus or the hospital or clinic. It’s an opportunity for patients who have busy schedules.”
“We also need to recognize how we support all communities in patient enrollment and incorporate different perspectives. Can multiple options to engage patients help us reach more individuals in diverse communities?” she adds.
In remote patient engagement, you must incorporate how to connect the patient with study teams if most visits are remote, explains Kottschade.
Communications and interactions may be through video visits, text messaging or an app that keeps the patients up to date on what’s happening for them in the clinical trial. It also supports the researcher in understanding if the patient has a concern, if they need to report an event or if they need any other type of help. Maintaining contact with the study team is imperative throughout a trial.
Study Design and Patient Safety
A critical step to study design is to understand the protocol and which components are going to be decentralized and what components are going to remain traditional or on campus; patient safety s top of mind. This involves considering what can be feasibly done in the home and what can be done in a clinic or hospital setting, recognizing the technology that will be used and being familiar with it, says Kottschade.
“We have regular conversations with our sponsors to understand topics like video consent, but there are specifics from a sponsor perspective that they may want to require a particular device or technology from a study perspective,” explains Kottschade.
This conversation needs to happen with the physician and the study team so there is an understanding of the things that can be done. “And this doesn’t mean that some complex tasks can’t be done in the home. We just need to be able to outline the plan and how to support it.”
Site Design
Designing a clinical trial site for decentralized trials involves ensuring there are robust infrastructure and IT systems to support virtual interactions, data collection and management. Facilitating integration with electronic health records (EHR) for seamless data exchange and access is also key.
User-friendly telemedicine platforms for virtual visits and consultations, as well as training and support for remote monitoring tools are important to consider when designing a trial site. This is particularly important in fostering a patient-centered design that involves systems that are easy and accessible for patients to use to help reduce barriers to participation. Providing robust patient support and education on how to use the technology and participate in the trial are critical to a successful site.
Secure data transmission and storage to maintain data integrity and security; designing sites and systems to be in compliance with regulatory standards and guidelines; training site staff on the use of decentralized trial technologies and processes; providing ongoing technical support for both staff and participants to address issues as they arise; and facilitate change management to help staff adapt to new ways of working are critical factors to consider in designing a trial with decentralized elements.
Kottschade says it is important to take the time to plan ahead so that people, both participants and staff, have a path to follow and navigate.
Thinking about what impact those capabilities have on processes and how they could change, as well as ensuring a solid relationship with the participating patient, are key to site planning.
The PI Perspective
Kottschade says the PI perspective is essential for the site or multi-site perspective.
And with the new FDA guidance, which highlights that PIs are ultimately responsible for the conduct of a trial, traditional or decentralized, understanding the PI oversight responsibility is imperative, explains Kottschade.
PIs also require the appropriate support as they are working with new technologies, patients in different settings and different teams and organizations. For example, it is important to consider the type of support needed when partnering with a mobile phlebotomy organization or a mobile nursing organization and to understand what the process looks like outside of the organization, explains Kottschade.
The Future of DCTs from a Site Perspective
The future of DCTs is poised for significant growth and transformation, driven by technological advancements, regulatory support and a growing recognition of the need for more patient-centric research models.
Kottschade says she thinks “DCTs will continue to be top of mind for our sponsors, pharmaceutical companies and the groups we work with as well as our sites.”
“We’ll continue to look for advancements in remote monitoring in how we can make the patient experience better and reduce the burden to participate. In the end, it’s up to an individual organization to determine how and what types of trials they decentralize.”
There are also financial and resource implications to consider with decentralized trial models. Ongoing analysis of the cost-effectiveness of DCTs compared to traditional trials will be important. Establishing clear models for reimbursement and compensation related to decentralized trial activities is another critical aspect to consider.
Collaboration between pharmaceutical companies, technology providers, healthcare providers and patient advocacy groups is imperative for trial success. Additionally, DCTs have the potential to facilitate more global clinical trials, increasing access to diverse patient populations.
By focusing on these areas, clinical sites can be effectively designed or adapted to support DCTs, enhancing patient accessibility, ensuring data quality and security and maintaining compliance with regulatory standards.
Decentralized trial models have the potential to significantly improve the patient experience and deliver robust clinical data. As the industry continues to evolve towards decentralized options, planning studies from both a patient-centric and site-centric approach will be key to the success of DCTs.
ABOUT Rebecca Kottschade
Career Summary
Becky Kottschade is a seasoned professional with over 20 years of financial and administrative experience in clinical research. She currently serves as the administrative leader of Mayo Clinic’s Decentralized Clinical Trials Initiative: Clinical Trials Beyond Walls (CTBW). In her current role, she leads teams to develop processes and technology solutions to support patient engagement regardless of their location, promotes patient optionality, and streamlining processes to enable study teams and researchers to incorporate decentralized capabilities into new and existing protocols supports the enablement of decentralized capabilities for Mayo Clinic researchers and study teams.
She is passionate about developing talent, improving processes, and creating great customer experiences. She aims to foster a culture of research excellence and engagement among Mayo Clinic staff and stakeholders to support patients in need of new treatments that only clinical research can provide.
Education and Certification
Becky holds a Master of Arts in Health and Human Services from St. Mary's University and a Bachelor of Science in Accounting from Winona State University. She is also a certified Project Management Professional (PMP) and an Instructor in Health Care Administration at Mayo Clinic.
Personal Statement
Clinical Research is not only a career for me but impacts me on a personal level. My family and I have benefited from the new treatments and discoveries that only clinical research can provide. My goal is supporting researchers as they strive for scientific discovery by streamlining processes, improving accessibility, and removing barriers.