Dive into the forefront of clinical trial innovation with our interview featuring Anthony Costello from Medidata. We discuss groundbreaking strategies for data interoperability, enhancing trial diversity, and navigating the regulatory landscape, showcasing how Medidata is redefining the future of clinical research.

Moe Alsumidaie: Anthony, can you share how Medidata’s new solutions, particularly the Clinical Data Studio and Health Record Connect, aim to overcome data interoperability and privacy challenges?

Anthony Costello: Absolutely, Moe. Our approach stems from a long history of grappling with these issues. The Clinical Data Studio is about creating a vast ecosystem of data availability, combining data from various sources used by partners and sponsors. It leverages AI for signal detection, optimizing data management in clinical trials. By contrast, Health Record Connect focuses more on site efficiency by providing ways sites can automatically share EHR source data with Rave and the rest of the Medidata platform. It’s designed to provide speed and efficiency while handling patient data with utmost privacy and care.

Moe: Could you explain how Health Record Connect operates and its role in enhancing clinical trial efficiency?

Anthony Costello: Health Record Connect is an enabling infrastructure for interoperability with various EHR systems. We are essentially utilizing the capabilities of intermediaries who have already established integrations with site-level EHR systems. This strategic approach allows us to bypass the lengthy process of negotiating individual agreements and standards-based data transfers with each institution. As for compatibility, we’re focused on integrating with major EHR systems like Epic and Cerner through these intermediaries.

Our new Rave Companion product, launching on the Health Record Connect infrastructure, will allow over 90% of Rave sites to transact EHR data directly into Rave. This is a quantum leap in site efficiency as, it eliminates the need for manual data entry from EHR to Rave, reducing errors and significantly improving operational efficiency. The data capture becomes almost touchless, with sites being able to visualize EHR data directly inside of Rave and select relevant values to be used on the Case Report Form (CRF). This seamless integration promotes data accuracy and streamlines the entire data management process in clinical trials.

Moe: Medidata is actively working on improving diversity in clinical trials. What strategies and technologies are you deploying to achieve this?

Anthony Costello: Our approach to enhancing diversity in clinical trials is multi-dimensional. One key aspect is our AI program, which plays a crucial role. By analyzing a vast trove of data from the 30,000 clinical trials and 9 million patients historically run on our platform, our AI can discern patterns and trends specific to diverse populations. This analysis enables us to understand where diverse populations are successfully engaged in clinical research and where there are gaps. For sponsors and sites, this means having access to insightful data that can guide better trial designs and recruitment strategies, ensuring trials are more inclusive and representative.

Anthony Costello, CEO, Medidata Solutions
Anthony Costello CEO Medidata Solutions

Additionally, our AI assists in reducing patient burden through improved trial operations. It helps identify optimal locations for trial sites and more effective ways to reach diverse patient groups. This is particularly beneficial in understanding the impact of logistical and socioeconomic factors on diverse participation in trials.

Through our partnership with Circuit Clinical, we’re also focusing on integrating site networks and research-naive sites into clinical trials. This is pivotal in building trust within diverse communities. By partnering with trusted healthcare organizations where patients are already engaged, we can begin to overcome trust barriers traditionally associated with clinical research. This approach helps diversify patient enrollment and extends the reach of trials to previously underrepresented areas, making clinical research more accessible and inclusive.

Moe: How do you measure the success of these diversity initiatives? Are there specific metrics you’re focusing on?

Anthony Costello: Our key focus is moving diversity measurement further upstream in the clinical trial process. We look at diverse recruitment at different stages – from initial protocol evaluation to patient consent and randomization. This includes assessing the diversity of investigators, site locations, and compensations affecting diverse participation. It’s about ensuring diversity is considered throughout the trial, not just an afterthought.

Moe: With a growing regulatory focus on diversity and decentralized clinical trials, how are Medidata’s programs aligned with these trends?

Anthony Costello: At Medidata, we proactively strive to stay ahead of regulatory trends, consistently pioneering innovations that eventually set industry standards. Our history showcases a pattern of leading the way in various clinical research domains well before these approaches receive formal regulatory guidance. This includes our early adoption of electronic data capture (EDC) systems, where we set a precedent for the industry, and our integration of AI into our platforms to enhance trial efficiency and data analysis, irrespective of the lack of initial regulatory frameworks.

Similarly, our foresight in implementing e-consent technologies has been instrumental in streamlining the consent process, enhancing participant engagement long before regulatory bodies established guidelines. Our approach to decentralized clinical trials (DCTs) is another prime example of our forward-thinking strategy.

We embraced DCT methodologies early, recognizing their potential to make clinical trials more patient-centric, accessible, and responsive to global challenges like the COVID-19 pandemic. This proactive approach to anticipating and shaping industry needs is central to our ethos, not just staying ahead of the curve but actively shaping it. By doing so, we benefit our clients and significantly contribute to fostering an environment where innovation is encouraged and supported, ultimately leading to more efficient, effective, and inclusive clinical trials.

Moe: What future innovations or improvements is Medidata focusing on to transform clinical trials and patient care further?

Anthony Costello: Our future is geared towards developing digital twins of patients, representing a significant leap in conducting clinical trials. The idea is to create a comprehensive healthcare ecosystem that extends beyond clinical trials, encompassing prevention, disease management, and long-term patient engagement. Technologies like the myMedidata app are steps towards this future, ensuring continued patient engagement even after a trial concludes.

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Moe Alsumidaie Chief Editor
Moe Alsumidaie is Chief Editor of The Clinical Trial Vanguard. Moe holds decades of experience in the clinical trials industry. Moe also serves as Head of Research at CliniBiz and Chief Data Scientist at Annex Clinical Corporation.