As clinical trial complexity continues to rise, effective technology is paramount. In this interview, we discussed clinical trial technology and operational challenges with Mike Hughes, Chief Product Officer at YPrime, and how he leverages advanced technology and a modular system approach to streamline clinical trials, making them more efficient and cost-effective. By actively engaging with key stakeholders in the clinical trial community, Hughes ensures that his solutions are not only technologically advanced but also user-friendly and directly responsive to the needs of site personnel, patients, and sponsors.

Moe: How Are You Addressing the Escalating Complexities and Rising Costs Associated with Clinical Trials?

Mike Hughes: At YPrime, we’re tackling the increasing complexities and rising costs of clinical trials by developing streamlined, cost-effective solutions. Our approach utilizes a sophisticated modular system integrating various technological tools into a seamless operation. The key to our approach is active engagement with the clinical trial community, including site personnel, patients, and sponsors. By prioritizing feedback from these essential stakeholders, we ensure our technology is advanced but also user-

Mike Hughes Chief Product Officer at YPrime

friendly and relevant. This commitment to practical innovation keeps clinical trials accessible, manageable, and poised for success, driving forward medical research in meaningful ways.

Moe: Could You Illustrate Your Approach in Practice?

Mike Hughes:
One example of YPrime’s strategic approach materializing into practical solutions is developing a specialized assessment tool for patients suffering from rheumatoid arthritis. Recognizing the complexity of evaluating numerous joints during clinical site visits, we designed this tool to simplify and expedite the assessment process. This innovation was brought to life with direct contributions from joint assessors on the front lines, interacting with patients and managing the intricacies of these evaluations daily. By integrating their firsthand insights, we were able to tailor the tool specifically to meet the unique needs of both patients and healthcare professionals. This tool elevates user satisfaction among patients and clinicians and enhances the quality and speed of data collection. Our focus on creating such targeted solutions demonstrates our commitment to pushing the boundaries of what’s possible in clinical trial management, making the entire process smoother and more responsive to all stakeholders’ needs.

Moe: How Have You Adapted to Decentralized Clinical Trials?

Mike Hughes:
While the COVID-19 pandemic accelerated the adoption of Decentralized Clinical Trials (DCTs), YPrime has long embraced remote data collection. We’re committed to offering technology solutions supporting decentralized and traditional clinical trial formats to meet the varied needs of patients and sponsors alike, making clinical trials more accessible and practical. Furthermore, our technology is flexible and designed to cater to traditional and decentralized trials, ensuring seamless support regardless of the trial format. This adaptability ensures we continue to lead in clinical trial innovation, enhancing participant and sponsor experiences and facilitating the generation of meaningful medical insights.

Moe: What Steps Do You Take to Uphold Data Integrity and Ensure Regulatory Compliance?

Mike Hughes: At YPrime, the pillars of our operation are the stringent upholding of data integrity and ensuring regulatory compliance across all aspects of our clinical trials. We implement advanced security measures such as biometric and multi-factor authentication to protect data and control access, reinforcing the trustworthiness of our research. Our platforms are intentionally designed to guide users through processes in full compliance with regulatory standards, emphasizing ease of use while maintaining rigorous data protection and integrity. Additionally, the global reach of clinical trials introduces the need to navigate diverse regulatory landscapes, a challenge we meet with our platform’s adaptability. Our platform is engineered to adjust to various international regulations, ensuring that our trials remain compliant and efficient, regardless of jurisdiction.

Moe: Looking to the Future, How Do AI and ML Technologies Stand to Revolutionize Clinical Trials?

Integrating Artificial Intelligence (AI) and Machine Learning (ML) into clinical trials marks a pivotal advancement, promising to enhance the efficiency and outcomes of these studies. However, the effectiveness of these technologies relies heavily on their ability to meet the real needs and preferences of end users, such as researchers, site personnel, and participants. We have prioritized the development of proofs of concept, closely involving end users in the feedback process to refine and ensure our AI and ML tools are practical, user-friendly, and genuinely improve clinical trial processes.

We understand the importance of making these advanced technologies accessible and beneficial to all involved in clinical trials. By engaging with end users throughout the development phase and fine-tuning our tools based on their input, we ensure our AI and ML innovations simplify rather than complicate, enhancing the user experience and overall trial effectiveness. Subsequently, this promotes the adoption of these technologies.

Moe: How Do You Navigate Client Concerns and Challenges?

Mike Hughes:
Our clients, particularly sponsors, are focused on speeding up trial processes, improving participant compliance, and reducing dropout rates. To address these challenges, we’ve designed our platforms to be both engaging for patients and intuitive for site personnel. This approach facilitates efficient and successful outcomes and addresses common hurdles, such as scheduling difficulties and communication gaps between patients and clinical staff. Moreover, we can boost compliance rates and minimize dropouts by incorporating tools that simplify scheduling, provide reminders, and open direct communication channels. These features create a supportive environment for participants, fostering sustained engagement and enabling trials to be completed on schedule.

Moe: Are There Additional Insights You’d Like to Share Regarding Your Vision for Clinical Trials?

Mike Hughes: The clinical trial industry has faced challenges with the slow adoption of new technologies, leading to inefficiencies that can delay critical medical research. We’re committed to changing this by introducing innovative software solutions designed to create a supportive and efficient ecosystem for site personnel and patients. This approach benefits everyone involved by improving retention and compliance and facilitating more complete data collection, which is crucial for developing new treatments.

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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.