ICON, the world’s leading clinical research organisation, continues its work for improving research processes with its Clinical Trial Tokenisation. We spoke to Kathleen Mandziuk, Vice President of Real-World Solutions and Tokenisation at ICON about the progressive work the solution has achieved since its inception.
ICON’s Clinical Trial Tokenisation melds clinical trial patient data tokenisation with real-world data, providing in-depth insights into drug safety and efficiency over time through advanced analytics. ICON’s dedication to data privacy, regulatory compliance and legal acumen makes them a foremost partner for research support. With access to a vast repository of patient-based health transactions, they’re poised to reshape evidence generation and research insights.
Can you tell us a little bit about your career and what led you to your role today?
I’ve had a 25-year career in clinical research, initially in data, then in clinical and project roles. My passion lies in improving drug development through innovative use of secondary data, particularly in real-world and post-marketing research. My background as a nurse and epidemiologist offers a unique blend of clinical experience and scientific knowledge. I’ve been part of the ICON organisation for 16 years and have witnessed its remarkable evolution.
Could you provide an overview of ICON’s clinical trial tokenisation solution and its primary objectives in the healthcare industry?
Secondary data has been around for a while in the healthcare space and we have witnessed open medical claims and electronic medical records grow over time.
When we started bringing more data within ICON, particularly with our Symphony Health Division that was acquired several years ago, we had our own open claims data available within ICON as well as our own token; Synoma. Being able to link healthcare data to follow a group of patients longitudinally and bi-directionally was really exciting. Not just from the commercial side, but also from the clinical and scientific side. I would say that four to five years ago, we started working with one of our partners to have a proof of concept determined, asking whether we could develop an approach to actually track our clinical trial patients within those data assets. Because with the patients in a clinical trial, you don’t have that visible data asset as it’s an investigational product. We’ve worked with them and developed an innovative solution to not only generate tokens within for clinical trial population and that data but also how we curate that data and then create powerful analytics.
ICON’s solution is not just a token, it’s an end-to-end approach. We’ve established a strong privacy framework, which is crucial when tokenising clinical trial patients. ICON, as a clinical research organisation, excels in this area, ensuring robust privacy and security measures. We’ve invested our expertise in enhancing flexibility to cater to various sponsor and asset requirements, making our solution adaptable and standardised.
How does this updated solution enable sponsors to leverage digital health tools effectively during clinical trials?
If a sponsor, for example, is developing a cellular therapy, they are required to follow patients for 10 – 15 years after they’ve taken their investigational treatment. Being able to tokenise those patients and follow their secondary data, even if they lose touch with them over that time, allows them to have a more robust approach. This also allows them to return to regulators showing their due diligence in following those patients and those exposed to advanced treatments.
It’s highly asset-specific in terms of products entering the market, differentiation comes from robust long-term safety, effectiveness and health economic data. These insights can create valuable publications and analysis, setting your product apart and offering unique advantages over competitors.
Patient privacy is a crucial concern in clinical trials. How does ICON ensure the protection of patient data while using real-world data?
It’s something that’s at the forefront of everything that we’ve built, and it starts with the clinical trial consent. Making sure that the patient is aware of what we’re doing and that we’re maintaining our security and privacy throughout the entire process.
Having the ability for patients to withdraw their consent at any time, even after the study is completed, where we might still be generating insights and also having the infrastructure in place to house and analyse the data in the correct fashion per our clinical trial regulations, is something we value and succeed in.
In what ways does this solution align with the current trends and advancements in the healthcare and pharmaceutical industries?
We are really focused on trends, constantly asking; how we leverage this, not only as a standalone solution for a clinical trial but also how this integrates with all the other advancements that we are making within clinical research. Being able to leverage things like Artificial Intelligence in analytics, for example, allows a more robust and advanced way of interpreting the results. I think it’s a key component of the future of clinical research.
What challenges do sponsors commonly face when integrating digital health tools and real-world data and how does ICON address these challenges?
We focus on educating various stakeholders in the clinical research space about clinical trial tokenisation, which is a relatively new concept. Providing this education helps our customers, trial sites and patients understand what it entails and its privacy framework. A few years ago, this concept was brand-new, but the industry is becoming more acquainted with it. The current discussion isn’t about what clinical trial tokenisation is but rather how to leverage it for asset value. Customers’ primary concern, particularly smaller BioTechs, is optimising the development of a specific asset. In contrast, large pharmaceutical companies prioritise timely study completion and approval. The perspective on clinical trial tokenisation and its long-term asset value varies based on the customer.
Recently, a customer likened tokenising their studies to a safety net or a bank. They invest in tokens, even without full knowledge of the insights they’ll derive. Having tokens allows them to conduct future analyses in response to questions from regulators or safety concerns. Ensuring upfront consent from patients and generating tokens from the beginning is crucial for this approach.
Are there any recent developments or future plans for ICON’s Clinical Trial Tokenisation solution that you can share with us?
Over the years, we’ve expanded our focus on short-term and long-term goals. Maximising the value of secondary real-world data is enhancing our internal capabilities and forging partnerships therefore by integrating multiple datasets, including our own tokens, we aim to create comprehensive insights for drug development through collaboration with the right partners.