Medidata Blog
Transforming the Clinical Research Experience
![Transforming the Clinical Research Experience](https://www.medidata.com/wp-content/uploads/2024/08/shutterstock_1255404034-1024x683.jpg)
In June 2024, Michael Peel, Science Editor of the Financial Times, moderated a FT LIVE webinar in partnership with Medidata, Transforming the Clinical Research Experience. This must-watch session featured key speakers representing patients, research sites, sponsors, and Medidata.
The panel’s unified message is that the transformation of the clinical trial experience begins with listening and understanding. Patient and site experiences are central to this.
Technology-driven advancements and evolving improvements in clinical trial practices have made significant contributions to the industry, but more can be done to enhance experiences for patients and site staff.
The patient population is diverse, with each individual having personal medical needs and specific preferences for study engagement. Without a positive patient experience, retention will be an issue. There isn’t a one-size-fits-all solution, so how can we enable a meaningful and effective patient experience?
Building Trust with Patients & Sites
Carole Scrafton, co-founder of Flutters and Strutters, a patient advocacy organization, feels that technology provides greater opportunities to build relationships and trust in clinical trials and healthcare:
“[Technology is] creating more avenues for liaison with patients. Engagement is becoming more possible, and because it's becoming more possible, [so is] the ability to relationship-build as early as possible.”
Understanding what is important to patients is at the heart of building the patient experience. Carole Scrafton and Viviënne van de Walle—co-founder of the independent clinical research site, PT&R, and member of the leadership council for the Society for Clinical Research Sites (SCRS)—talked about the importance of patients feeling valued and included.
Julia Chernova, Associate Director, Clinical Data Science and Digital Health, Bayer Pharmaceuticals, pointed out that if a patient is not seeing progress from their treatments during the trial, a possible decline in motivation will add to the retention issue.
In addition to the care and therapy received during a study, patients will naturally ask for information or feedback. Both Carole and Viviënne highlighted that this patient feedback loop is missing and needs to be implemented while also ensuring data security, privacy, and compliance.
Julia highlighted the problem that:
“...no matter how much we would like to give back the data, it's not possible while the trial is running because that goes against all best practices and against all the regulations. It would not be fair, neither to the patients, not to the teams, not to the sponsor—blinding patients is essential.”
Tom Doyle, SVP and Chief Technology Officer at Medidata, shared new ways to help patients feel included, see feedback, and share their experiences in clinical trials. Additionally, sensors and wearables allow data collection to be less intrusive while enabling a deeper understanding of the patient experience.
The panelists agreed that a balance is needed to achieve compliance while providing an inclusive experience for patients. Carole and Viviënne’s recommendation was to use shareable data that provides patients with insights that are of interest to them. Examples of questions that add value for patients were: What’s the impact of their participation in a study? How’s the data being used? How will the study help other patients in the future?
The panel also shared examples that highlighted how a patient’s circumstances must always be taken into account. Julia commented that technology adoption by patients varies, and she gave an example of one study where “...out of [one] hundred patients, only three patients agreed to use wearables or sensors.” Not all patients want or have access to WiFi or technology, so she emphasized the importance of offering alternative methods for participation in a study.
DCT (decentralized clinical trials) and hybrid studies have created a different trial experience for patients, and Julia pointed out that this is still a novel approach for Bayer. While this is the case, OCEANIC, Bayer’s pivotal phase III global trial, has been described as an innovative trailblazer in DCT execution. The 18,000-patient global study was originally conceived as a hybrid study but transitioned to a fully remote trial. It was ideally suited to a DCT model due to the nature of its compounds, streamlined protocol, and the need for direct patient interaction.
Another reason for Bayer’s success was its ability to achieve seamless integration of disparate technologies–such as ePRO, eConsent, telehealth, etc.–through successful multi-channel management and collaboration with diverse solution providers. Tom pointed out that the patient experience has shifted, creating optionality for individuals. Involving patients and patient advocates in the design and development of Medidata software ensures a better patient experience all around.
In the same vein, Viviënne stated, “It helps to be at the drawing table with a sponsor when they're developing the protocol or program for a certain drug, to have input on the challenges [and] the bottlenecks we see.”
Technology as an Enabler
Tom commented that technology is an enabler, increasing participation, improving retention, and collecting more data with the potential to be used beyond the scope of a study. In addition to continuous improvement of the Medidata ecosystem, the industry is ever-evolving and working to meet the challenges and needs of data management and compliance.
Data privacy and security are critical, of course, and the discussion touched on the complexities of managing data from the increasing number of medical devices—sensors, wearables, smart devices—and varying global data regulatory requirements. While the benefits of technology are significant, providing a multitude of systems, devices, and solutions leads to a lack of consistency and adds to operational complexity for research sites. The breadth and volume of data collected has increased, bringing about both benefits and challenges.
Tom talked about how historically clinical trial data has been collected to serve a specific study, with the goal of gathering the minimum required information. That method successfully served its purpose, bringing novel treatments to billions of people around the world, but:
“... it's also a little bit of a paradox. We know that the more data we collect, the more we're able to use that. The more insights that we will be able to glean, that will help us uncover the next generation of treatments and the next generation of better experiences for patients that only come through partnerships.”
Viviënne agreed and shared examples of data that sites collect that fall outside the scope of a specific study. This data could have been used if patient consent had been given.
Faced with this larger data ecosystem, the potential benefits of using data to drive innovation and assist in other studies are significant and clear, but there are further challenges that need to be addressed.
From a sponsor’s perspective, Julia shared her view:
“[There are] two domains that are a challenge: [The first is] a coordination problem… coordination of partnerships, coordination of funders, a commission of stakeholders, externally and internally as we need to establish new processes. We need to understand what that value is.
The second biggest challenge is to figure out the impact… what we need to do and how we can do it in a more efficient way that maximizes the impact of the new technologies.”
Additionally, during vendor selection, a vendor’s engagement with sites and clinical research associated with patients is a key part of their assessment.
Viviënne commented that sites are the interface between sponsors, technology, and patients. While they see benefits from the technologies provided when asked to use a variety of disparate systems, it increases site burden, leading to what she called “an escape room experience.” This greatly impacts both the patient and site experience.
With the increasing complexity of studies, the volumes and multitude of data have increased for review and management. And data review, cleaning, and management have become more burdensome. So what can be done?
The Role of AI
AI (artificial intelligence) is playing an increasingly transformational role throughout the clinical trial process to create better patient and site experiences for better outcomes. Quoting Tom, “The limit of AI is identifying opportunity… AI-assisted solutions are surfacing in the collective knowledge of very engaged researcher sites and patient populations.” Examples include AI-assisted recruitment to identify underserved populations, accelerating operational tasks, data management, designing protocols, and identifying potential risks.
Medidata’s use of AI also follows a human-in-the-loop process to ensure supervised management is in place. Not all AI systems have this in place, and Viviënne shared examples of AI-assisted failures, highlighting the need for due diligence when selecting systems.
In Conclusion
Transforming the clinical research experience is dependent on a deep understanding of the challenges faced across the industry and the ability to adapt as the industry evolves. Inviting feedback and input from key stakeholders in the industry is a critical part of this change.
Medidata’s solutions have been designed with patients and sites in mind, collecting feedback from patient advocacy groups and site staff. This includes the well-established Patient Insights Program—whose services not only inform the development of Medidata’s patient-facing technologies, but are also available to guide customers—and the SiteTech Board, jointly run with the SCRS to gain research site feedback.